Trial Outcomes & Findings for Testing a Brief Substance Misuse Preventative Intervention for Parents/Guardians of 5th-7th Grade Students (NCT NCT03925220)

NCT ID: NCT03925220

Last Updated: 2025-07-09

Results Overview

Positive and negative expectancies about the affective, cognitive, and behavioral effects of cigarette use will be assessed with the Positive and Negative Outcome Expectancies of Smoking scale. The tool comprises 12 items, each with response options ranging from (1) Strongly Disagree to (6) Strongly Agree. The tool has two subscales (positive expectancies, determined by 7 questions; negative expectancies, determined by 5 questions). Summary scores for both the positive and negative expectancies are created. Summary score values range from 0-7 for positive, 0-5 for negative expectancies. Higher score on positive expectancies scale indicates a greater belief that there are positive outcomes of smoking. Higher score on negative expectancies scale indicates a greater belief in negative consequences of smoking. This measure was reported by children only.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

402 participants

Primary outcome timeframe

18 months

Results posted on

2025-07-09

Participant Flow

The protocol enrollment reflects the number of parent and child dyads enrolled in the study. Before COVID-19, participants were recruited through schools. After COVID-19, participants were recruited through community-based organizations and an online recruitment company.

Participants were screened for eligibility and had to complete all baseline assessments. Parents and children were eligible to participate if: (1) the child was enrolled in 5th, 6th, or 7th grade at a school within Massachusetts at the time of recruitment, (2) the child and parent were able to independently complete study activities in English or Spanish, (3) the parent and child were living together at least 50% of the time, (4) parents consent to participate and child gives assent.

Participant milestones

Participant milestones
Measure
Substance Use Prevention Intervention - Parents
Parents were given a handbook specific to the gender of their child that provides information and advice on communication and substance use prevention. Parents then participated in a one-hour session with an interventionist where the main points in the handbook were reviewed and they filled out an action plan on how to make changes in communication about substances with their child. The interventionist also provided parents with a referral packet. Two weeks after the live session, participants had a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents received two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Substance Use Prevention Intervention - Children
Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Nutrition, Physical Activity, and Weight Talk Comparison - Parents
Parents received a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Parents also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had the 30-minute call, as well as receive two text messages twice per week for 13 weeks with tips and reminders from the comparison handbook and insert.
Nutrition, Physical Activity, and Weight Talk Comparison - Children
Children discussed with their parents a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert.
Overall Study
STARTED
201
201
201
201
Overall Study
Baseline Analyzed
192
192
196
196
Overall Study
3 Months Follow-up
181
181
185
185
Overall Study
6 Months Follow-up
159
159
170
170
Overall Study
12 Months Follow-up
152
148
150
150
Overall Study
18 Months Follow-up
157
151
160
159
Overall Study
COMPLETED
157
151
160
159
Overall Study
NOT COMPLETED
44
50
41
42

Reasons for withdrawal

Reasons for withdrawal
Measure
Substance Use Prevention Intervention - Parents
Parents were given a handbook specific to the gender of their child that provides information and advice on communication and substance use prevention. Parents then participated in a one-hour session with an interventionist where the main points in the handbook were reviewed and they filled out an action plan on how to make changes in communication about substances with their child. The interventionist also provided parents with a referral packet. Two weeks after the live session, participants had a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents received two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Substance Use Prevention Intervention - Children
Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Nutrition, Physical Activity, and Weight Talk Comparison - Parents
Parents received a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Parents also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had the 30-minute call, as well as receive two text messages twice per week for 13 weeks with tips and reminders from the comparison handbook and insert.
Nutrition, Physical Activity, and Weight Talk Comparison - Children
Children discussed with their parents a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert.
Overall Study
Withdrawal by Subject
4
4
4
4
Overall Study
Lost to Follow-up
40
46
37
38

Baseline Characteristics

Missing participants did not answer the survey question.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Substance Use Prevention Intervention
n=192 Participants
Parents were given a handbook specific to the gender of their child that provides information and advice communication and substance use prevention. Parents then participated in a one-hour session with an interventionist where the main points in the handbook were reviewed and they filled out an action plan on how to make changes in communication about substances with their child. The interventionist also provided parents with a referral packet. Two weeks after the live session, participants had a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents received two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Substance Use Prevention Intervention - Children
n=192 Participants
Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Nutrition, Physical Activity, and Weight Talk Comparison
n=196 Participants
For the comparison condition, after the baseline assessment, parents received a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Parents also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had the 30-minute call, as well as receive two text messages twice per week for 13 weeks with tips and reminders from the comparison handbook and insert.
Nutrition, Physical Activity, and Weight Talk Comparison - Children
n=196 Participants
Children discussed with their parents a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert.
Total
n=776 Participants
Total of all reporting groups
Frequency of parent-child conversations on substances
On using cannabis · 'Several times' or 'a lot'
16 Participants
n=5 Participants • Missing participants did not answer the survey question.
14 Participants
n=7 Participants • Missing participants did not answer the survey question.
27 Participants
n=5 Participants • Missing participants did not answer the survey question.
18 Participants
n=4 Participants • Missing participants did not answer the survey question.
75 Participants
n=21 Participants • Missing participants did not answer the survey question.
Frequency of parent-child conversations on substances
On using cannabis · 'None', 'once', or 'a few times'
176 Participants
n=5 Participants • Missing participants did not answer the survey question.
178 Participants
n=7 Participants • Missing participants did not answer the survey question.
169 Participants
n=5 Participants • Missing participants did not answer the survey question.
178 Participants
n=4 Participants • Missing participants did not answer the survey question.
701 Participants
n=21 Participants • Missing participants did not answer the survey question.
Age, Continuous
42.1 years
STANDARD_DEVIATION 6.3 • n=5 Participants
11.8 years
STANDARD_DEVIATION 1.1 • n=7 Participants
43.3 years
STANDARD_DEVIATION 6.8 • n=5 Participants
11.8 years
STANDARD_DEVIATION 1.0 • n=4 Participants
27.3 years
STANDARD_DEVIATION 3.8 • n=21 Participants
Sex: Female, Male
Female
169 Participants
n=5 Participants
99 Participants
n=7 Participants
173 Participants
n=5 Participants
102 Participants
n=4 Participants
543 Participants
n=21 Participants
Sex: Female, Male
Male
23 Participants
n=5 Participants
93 Participants
n=7 Participants
23 Participants
n=5 Participants
94 Participants
n=4 Participants
233 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
41 Participants
n=5 Participants
48 Participants
n=7 Participants
40 Participants
n=5 Participants
42 Participants
n=4 Participants
171 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
151 Participants
n=5 Participants
144 Participants
n=7 Participants
156 Participants
n=5 Participants
154 Participants
n=4 Participants
605 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Asian
8 Participants
n=5 Participants
9 Participants
n=7 Participants
7 Participants
n=5 Participants
4 Participants
n=4 Participants
28 Participants
n=21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
3 Participants
n=21 Participants
Race (NIH/OMB)
Black or African American
19 Participants
n=5 Participants
21 Participants
n=7 Participants
26 Participants
n=5 Participants
28 Participants
n=4 Participants
94 Participants
n=21 Participants
Race (NIH/OMB)
White
117 Participants
n=5 Participants
104 Participants
n=7 Participants
118 Participants
n=5 Participants
110 Participants
n=4 Participants
449 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
7 Participants
n=5 Participants
9 Participants
n=7 Participants
4 Participants
n=5 Participants
11 Participants
n=4 Participants
31 Participants
n=21 Participants
Race (NIH/OMB)
Unknown or Not Reported
41 Participants
n=5 Participants
48 Participants
n=7 Participants
40 Participants
n=5 Participants
42 Participants
n=4 Participants
171 Participants
n=21 Participants
Region of Enrollment
United States
192 Participants
n=5 Participants
192 Participants
n=7 Participants
196 Participants
n=5 Participants
196 Participants
n=4 Participants
776 Participants
n=21 Participants
Frequency of parent-child conversations on substances
On drinking alcohol · 'Several times' or 'a lot'
28 Participants
n=5 Participants • Missing participants did not answer the survey question.
17 Participants
n=7 Participants • Missing participants did not answer the survey question.
36 Participants
n=5 Participants • Missing participants did not answer the survey question.
23 Participants
n=4 Participants • Missing participants did not answer the survey question.
104 Participants
n=21 Participants • Missing participants did not answer the survey question.
Frequency of parent-child conversations on substances
On drinking alcohol · 'None', 'once', or 'a few times'
164 Participants
n=5 Participants • Missing participants did not answer the survey question.
175 Participants
n=7 Participants • Missing participants did not answer the survey question.
160 Participants
n=5 Participants • Missing participants did not answer the survey question.
173 Participants
n=4 Participants • Missing participants did not answer the survey question.
672 Participants
n=21 Participants • Missing participants did not answer the survey question.
Frequency of parent-child conversations on substances
On smoking cigarettes · 'Several times' or 'a lot'
23 Participants
n=5 Participants • Missing participants did not answer the survey question.
12 Participants
n=7 Participants • Missing participants did not answer the survey question.
26 Participants
n=5 Participants • Missing participants did not answer the survey question.
19 Participants
n=4 Participants • Missing participants did not answer the survey question.
80 Participants
n=21 Participants • Missing participants did not answer the survey question.
Frequency of parent-child conversations on substances
On smoking cigarettes · 'None', 'once', or 'a few times'
169 Participants
n=5 Participants • Missing participants did not answer the survey question.
180 Participants
n=7 Participants • Missing participants did not answer the survey question.
170 Participants
n=5 Participants • Missing participants did not answer the survey question.
177 Participants
n=4 Participants • Missing participants did not answer the survey question.
696 Participants
n=21 Participants • Missing participants did not answer the survey question.
Frequency of parent-child conversations on substances
On vaping · 'Several times' or 'a lot'
19 Participants
n=5 Participants • Missing participants did not answer the survey question.
14 Participants
n=7 Participants • Missing participants did not answer the survey question.
31 Participants
n=5 Participants • Missing participants did not answer the survey question.
13 Participants
n=4 Participants • Missing participants did not answer the survey question.
77 Participants
n=21 Participants • Missing participants did not answer the survey question.
Frequency of parent-child conversations on substances
On vaping · 'None', 'once', or 'a few times'
173 Participants
n=5 Participants • Missing participants did not answer the survey question.
178 Participants
n=7 Participants • Missing participants did not answer the survey question.
165 Participants
n=5 Participants • Missing participants did not answer the survey question.
183 Participants
n=4 Participants • Missing participants did not answer the survey question.
699 Participants
n=21 Participants • Missing participants did not answer the survey question.
Frequency of parent-child conversations on substances
On using other drugs · 'Several times' or 'a lot'
23 Participants
n=5 Participants • Missing participants did not answer the survey question.
17 Participants
n=7 Participants • Missing participants did not answer the survey question.
23 Participants
n=5 Participants • Missing participants did not answer the survey question.
25 Participants
n=4 Participants • Missing participants did not answer the survey question.
88 Participants
n=21 Participants • Missing participants did not answer the survey question.
Frequency of parent-child conversations on substances
On using other drugs · 'None', 'once', or 'a few times'
169 Participants
n=5 Participants • Missing participants did not answer the survey question.
175 Participants
n=7 Participants • Missing participants did not answer the survey question.
173 Participants
n=5 Participants • Missing participants did not answer the survey question.
171 Participants
n=4 Participants • Missing participants did not answer the survey question.
688 Participants
n=21 Participants • Missing participants did not answer the survey question.
Targeted parent-child communication on substance use
Warned about the dangers · Agree
142 Participants
n=5 Participants
164 Participants
n=7 Participants
157 Participants
n=5 Participants
168 Participants
n=4 Participants
631 Participants
n=21 Participants
Targeted parent-child communication on substance use
Warned about the dangers · Disagree
50 Participants
n=5 Participants
28 Participants
n=7 Participants
39 Participants
n=5 Participants
28 Participants
n=4 Participants
145 Participants
n=21 Participants
Targeted parent-child communication on substance use
Talked about how to handle offers · Agree
81 Participants
n=5 Participants
122 Participants
n=7 Participants
88 Participants
n=5 Participants
116 Participants
n=4 Participants
407 Participants
n=21 Participants
Targeted parent-child communication on substance use
Talked about how to handle offers · Disagree
111 Participants
n=5 Participants
70 Participants
n=7 Participants
108 Participants
n=5 Participants
80 Participants
n=4 Participants
369 Participants
n=21 Participants
Targeted parent-child communication on substance use
Given rules to obey · Agree
72 Participants
n=5 Participants
115 Participants
n=7 Participants
82 Participants
n=5 Participants
111 Participants
n=4 Participants
380 Participants
n=21 Participants
Targeted parent-child communication on substance use
Given rules to obey · Disagree
120 Participants
n=5 Participants
77 Participants
n=7 Participants
114 Participants
n=5 Participants
85 Participants
n=4 Participants
396 Participants
n=21 Participants
Targeted parent-child communication on substance use
Not directly talked but given hints · Agree
44 Participants
n=5 Participants
58 Participants
n=7 Participants
41 Participants
n=5 Participants
64 Participants
n=4 Participants
207 Participants
n=21 Participants
Targeted parent-child communication on substance use
Not directly talked but given hints · Disagree
148 Participants
n=5 Participants
134 Participants
n=7 Participants
155 Participants
n=5 Participants
132 Participants
n=4 Participants
569 Participants
n=21 Participants
Targeted parent-child communication on substance use
Lectured or given speech · Agree
69 Participants
n=5 Participants
84 Participants
n=7 Participants
66 Participants
n=5 Participants
88 Participants
n=4 Participants
307 Participants
n=21 Participants
Targeted parent-child communication on substance use
Lectured or given speech · Disagree
123 Participants
n=5 Participants
108 Participants
n=7 Participants
130 Participants
n=5 Participants
108 Participants
n=4 Participants
469 Participants
n=21 Participants
Targeted parent-child communication on substance use
Made a comment on character on TV · Agree
69 Participants
n=5 Participants
70 Participants
n=7 Participants
78 Participants
n=5 Participants
73 Participants
n=4 Participants
290 Participants
n=21 Participants
Targeted parent-child communication on substance use
Made a comment on character on TV · Disagree
123 Participants
n=5 Participants
122 Participants
n=7 Participants
118 Participants
n=5 Participants
123 Participants
n=4 Participants
486 Participants
n=21 Participants
Targeted parent-child communication on substance use
Told stories of people · Agree
104 Participants
n=5 Participants
58 Participants
n=7 Participants
104 Participants
n=5 Participants
75 Participants
n=4 Participants
341 Participants
n=21 Participants
Targeted parent-child communication on substance use
Told stories of people · Disagree
88 Participants
n=5 Participants
134 Participants
n=7 Participants
92 Participants
n=5 Participants
121 Participants
n=4 Participants
435 Participants
n=21 Participants
Targeted parent-child communication on substance use
Told they would be disappointed · Agree
49 Participants
n=5 Participants
91 Participants
n=7 Participants
57 Participants
n=5 Participants
95 Participants
n=4 Participants
292 Participants
n=21 Participants
Targeted parent-child communication on substance use
Told they would be disappointed · Disagree
143 Participants
n=5 Participants
101 Participants
n=7 Participants
139 Participants
n=5 Participants
101 Participants
n=4 Participants
484 Participants
n=21 Participants
Targeted parent-child communication on substance use
Shown information about the dangers · Agree
53 Participants
n=5 Participants
50 Participants
n=7 Participants
47 Participants
n=5 Participants
59 Participants
n=4 Participants
209 Participants
n=21 Participants
Targeted parent-child communication on substance use
Shown information about the dangers · Disagree
139 Participants
n=5 Participants
142 Participants
n=7 Participants
149 Participants
n=5 Participants
137 Participants
n=4 Participants
567 Participants
n=21 Participants
Targeted parent-child communication on substance use
Asked about their thoughts/opinions · Agree
102 Participants
n=5 Participants
106 Participants
n=7 Participants
107 Participants
n=5 Participants
115 Participants
n=4 Participants
430 Participants
n=21 Participants
Targeted parent-child communication on substance use
Asked about their thoughts/opinions · Disagree
90 Participants
n=5 Participants
86 Participants
n=7 Participants
89 Participants
n=5 Participants
81 Participants
n=4 Participants
346 Participants
n=21 Participants

PRIMARY outcome

Timeframe: 3 months (short-term) and 18 months (long-term)

Population: Sample sizes differ for parent- and child-reported data based on how many parents and children completed the survey at each follow-up.

Frequency of conversations was measured using an item adapted from a measure for parent-child communication about sex (Miller et al, 1998). Question: "During the past 3-months, how many times have you and your child talked about \[substance\]?" The same question assessed frequency for each substance of interest (alcohol, cigarettes, e-cigarettes, cannabis, other drugs) on a five-point Likert scale from "None" to "A lot". Responses were dichotomized as "Several" or "A lot" versus "None", "Once", or "A few times". This measure was reported by parents and children.

Outcome measures

Outcome measures
Measure
Substance Use Prevention Intervention
n=178 Participants
Parents were given a handbook specific to the gender of their child that provides information and advice communication and substance use prevention. Parents then participated in a one-hour session with an interventionist where the main points in the handbook were reviewed and they filled out an action plan on how to make changes in communication about substances with their child. The interventionist also provided parents with a referral packet. Two weeks after the live session, participants had a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents received two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Substance Use Prevention Intervention - Children
n=178 Participants
Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Nutrition, Physical Activity, and Weight Talk Comparison
n=185 Participants
For the comparison condition, after the baseline assessment, parents received a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Parents also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had the 30-minute call, as well as receive two text messages twice per week for 13 weeks with tips and reminders from the comparison handbook and insert.
Nutrition, Physical Activity, and Weight Talk Comparison - Children
n=185 Participants
Children discussed with their parents a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert.
Frequency of Parent-child Conversations on Substances
3-months - drinking alcohol · 'Several times' or 'a lot'
87 Participants
32 Participants
29 Participants
20 Participants
Frequency of Parent-child Conversations on Substances
3-months - drinking alcohol · 'None', 'once', or 'a few times'
91 Participants
146 Participants
156 Participants
165 Participants
Frequency of Parent-child Conversations on Substances
3-months - using e-cigarettes or vaping · 'Several times' or 'a lot'
70 Participants
28 Participants
28 Participants
17 Participants
Frequency of Parent-child Conversations on Substances
3-months - using e-cigarettes or vaping · 'None', 'once', or 'a few times'
108 Participants
150 Participants
157 Participants
168 Participants
Frequency of Parent-child Conversations on Substances
3-months - using marijuana · 'Several times' or 'a lot'
61 Participants
20 Participants
27 Participants
17 Participants
Frequency of Parent-child Conversations on Substances
3-months - using marijuana · 'None', 'once', or 'a few times'
117 Participants
158 Participants
158 Participants
168 Participants
Frequency of Parent-child Conversations on Substances
3-months - smoking cigarettes · 'Several times' or 'a lot'
79 Participants
28 Participants
23 Participants
21 Participants
Frequency of Parent-child Conversations on Substances
3-months - smoking cigarettes · 'None', 'once', or 'a few times'
99 Participants
150 Participants
162 Participants
164 Participants
Frequency of Parent-child Conversations on Substances
3-months - using other drugs · 'Several times' or 'a lot'
55 Participants
25 Participants
20 Participants
19 Participants
Frequency of Parent-child Conversations on Substances
3-months - using other drugs · 'None', 'once', or 'a few times'
123 Participants
153 Participants
165 Participants
166 Participants
Frequency of Parent-child Conversations on Substances
18-months - drinking alcohol · 'Several times' or 'a lot'
51 Participants
30 Participants
36 Participants
28 Participants
Frequency of Parent-child Conversations on Substances
18-months - drinking alcohol · 'None', 'once', or 'a few times'
106 Participants
121 Participants
124 Participants
131 Participants
Frequency of Parent-child Conversations on Substances
18-months - using e-cigarettes or vaping · 'Several times' or 'a lot'
40 Participants
22 Participants
33 Participants
18 Participants
Frequency of Parent-child Conversations on Substances
18-months - using e-cigarettes or vaping · 'None', 'once', or 'a few times'
117 Participants
129 Participants
127 Participants
141 Participants
Frequency of Parent-child Conversations on Substances
18-months - using marijuana · 'Several times' or 'a lot'
38 Participants
26 Participants
30 Participants
22 Participants
Frequency of Parent-child Conversations on Substances
18-months - using marijuana · 'None', 'once', or 'a few times'
119 Participants
125 Participants
130 Participants
137 Participants
Frequency of Parent-child Conversations on Substances
18-months - smoking cigarettes · 'Several times' or 'a lot'
33 Participants
22 Participants
28 Participants
18 Participants
Frequency of Parent-child Conversations on Substances
18-months - smoking cigarettes · 'None', 'once', or 'a few times'
124 Participants
129 Participants
132 Participants
141 Participants
Frequency of Parent-child Conversations on Substances
18-months - using other drugs · 'Several times' or 'a lot'
28 Participants
23 Participants
26 Participants
19 Participants
Frequency of Parent-child Conversations on Substances
18-months - using other drugs · 'None', 'once', or 'a few times'
129 Participants
128 Participants
134 Participants
140 Participants

PRIMARY outcome

Timeframe: 3 months (short-term) and 18 months (long-term)

Population: Sample sizes differ for parent- and child-reported data based on how many parents and children completed the survey at each follow-up.

An adapted version of the Targeted Parent-Child Communication about Alcohol Scale (Miller-Day et al, 2010) was used to assess targeted communication about alcohol and other drugs use. The ten-item assesses parents' agreement on having communication about substance use related topics and applying strategies parents may have discussed with their child. Items were assessed on a six-point Likert scale from "Strongly agree" to "Strongly disagree". Responses were dichotomized as "Agree" or "Strongly Agree" versus "Strongly Disagree" to "Somewhat Agree". This measure was reported by parents and children.

Outcome measures

Outcome measures
Measure
Substance Use Prevention Intervention
n=181 Participants
Parents were given a handbook specific to the gender of their child that provides information and advice communication and substance use prevention. Parents then participated in a one-hour session with an interventionist where the main points in the handbook were reviewed and they filled out an action plan on how to make changes in communication about substances with their child. The interventionist also provided parents with a referral packet. Two weeks after the live session, participants had a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents received two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Substance Use Prevention Intervention - Children
n=181 Participants
Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Nutrition, Physical Activity, and Weight Talk Comparison
n=185 Participants
For the comparison condition, after the baseline assessment, parents received a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Parents also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had the 30-minute call, as well as receive two text messages twice per week for 13 weeks with tips and reminders from the comparison handbook and insert.
Nutrition, Physical Activity, and Weight Talk Comparison - Children
n=185 Participants
Children discussed with their parents a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert.
Targeted Parent-child Communication on Substance Use
3 months - warned about the dangers · Agree
162 Participants
147 Participants
126 Participants
143 Participants
Targeted Parent-child Communication on Substance Use
3 months - warned about the dangers · Disagree
19 Participants
34 Participants
59 Participants
42 Participants
Targeted Parent-child Communication on Substance Use
3 months - talked about how to handle offers · Agree
137 Participants
125 Participants
81 Participants
106 Participants
Targeted Parent-child Communication on Substance Use
3 months - talked about how to handle offers · Disagree
44 Participants
56 Participants
104 Participants
79 Participants
Targeted Parent-child Communication on Substance Use
3 months - given rules to obey · Agree
139 Participants
111 Participants
61 Participants
104 Participants
Targeted Parent-child Communication on Substance Use
3 months - given rules to obey · Disagree
42 Participants
70 Participants
124 Participants
81 Participants
Targeted Parent-child Communication on Substance Use
3 months - not directly talked but given hints on not to use · Agree
18 Participants
39 Participants
29 Participants
59 Participants
Targeted Parent-child Communication on Substance Use
3 months - not directly talked but given hints on not to use · Disagree
163 Participants
142 Participants
156 Participants
126 Participants
Targeted Parent-child Communication on Substance Use
3 months - lectured or given speech · Agree
71 Participants
83 Participants
41 Participants
68 Participants
Targeted Parent-child Communication on Substance Use
3 months - lectured or given speech · Disagree
110 Participants
98 Participants
144 Participants
117 Participants
Targeted Parent-child Communication on Substance Use
3 months - made a comment if a character on TV is drinking/drunk · Agree
83 Participants
84 Participants
57 Participants
64 Participants
Targeted Parent-child Communication on Substance Use
3 months - made a comment if a character on TV is drinking/drunk · Disagree
98 Participants
97 Participants
128 Participants
121 Participants
Targeted Parent-child Communication on Substance Use
3 months - told stories of people who drink or have been drunk or use drugs · Agree
112 Participants
60 Participants
86 Participants
60 Participants
Targeted Parent-child Communication on Substance Use
3 months - told stories of people who drink or have been drunk or use drugs · Disagree
69 Participants
121 Participants
99 Participants
125 Participants
Targeted Parent-child Communication on Substance Use
3 months - told they would be disappointed · Agree
88 Participants
77 Participants
47 Participants
71 Participants
Targeted Parent-child Communication on Substance Use
3 months - told they would be disappointed · Disagree
93 Participants
104 Participants
138 Participants
114 Participants
Targeted Parent-child Communication on Substance Use
3 months - shown information about the dangers · Agree
71 Participants
50 Participants
48 Participants
44 Participants
Targeted Parent-child Communication on Substance Use
3 months - shown information about the dangers · Disagree
110 Participants
131 Participants
137 Participants
141 Participants
Targeted Parent-child Communication on Substance Use
3 months - asked about their thoughts or opinions · Agree
144 Participants
101 Participants
83 Participants
81 Participants
Targeted Parent-child Communication on Substance Use
3 months - asked about their thoughts or opinions · Disagree
37 Participants
80 Participants
102 Participants
104 Participants
Targeted Parent-child Communication on Substance Use
18 months - warned about the dangers · Agree
114 Participants
108 Participants
105 Participants
108 Participants
Targeted Parent-child Communication on Substance Use
18 months - warned about the dangers · Disagree
43 Participants
43 Participants
55 Participants
51 Participants
Targeted Parent-child Communication on Substance Use
18 months - talked about how to handle offers · Agree
95 Participants
93 Participants
76 Participants
81 Participants
Targeted Parent-child Communication on Substance Use
18 months - talked about how to handle offers · Disagree
62 Participants
58 Participants
84 Participants
78 Participants
Targeted Parent-child Communication on Substance Use
18 months - given rules to obey · Agree
87 Participants
92 Participants
63 Participants
74 Participants
Targeted Parent-child Communication on Substance Use
18 months - given rules to obey · Disagree
70 Participants
59 Participants
97 Participants
85 Participants
Targeted Parent-child Communication on Substance Use
18 months - not directly talked but given hints on not to use · Agree
18 Participants
22 Participants
27 Participants
49 Participants
Targeted Parent-child Communication on Substance Use
18 months - not directly talked but given hints on not to use · Disagree
139 Participants
129 Participants
133 Participants
110 Participants
Targeted Parent-child Communication on Substance Use
18 months - lectured or given speech · Agree
50 Participants
62 Participants
32 Participants
47 Participants
Targeted Parent-child Communication on Substance Use
18 months - lectured or given speech · Disagree
107 Participants
89 Participants
128 Participants
112 Participants
Targeted Parent-child Communication on Substance Use
18 months - made a comment if a character on TV is drinking/drunk · Agree
69 Participants
47 Participants
50 Participants
52 Participants
Targeted Parent-child Communication on Substance Use
18 months - made a comment if a character on TV is drinking/drunk · Disagree
88 Participants
104 Participants
110 Participants
107 Participants
Targeted Parent-child Communication on Substance Use
18 months - told stories of people who drink or have been drunk or use drugs · Agree
90 Participants
55 Participants
76 Participants
52 Participants
Targeted Parent-child Communication on Substance Use
18 months - told stories of people who drink or have been drunk or use drugs · Disagree
67 Participants
96 Participants
84 Participants
107 Participants
Targeted Parent-child Communication on Substance Use
18 months - told they would be disappointed · Agree
56 Participants
59 Participants
41 Participants
52 Participants
Targeted Parent-child Communication on Substance Use
18 months - told they would be disappointed · Disagree
101 Participants
92 Participants
119 Participants
107 Participants
Targeted Parent-child Communication on Substance Use
18 months - shown information about the dangers · Agree
56 Participants
36 Participants
38 Participants
37 Participants
Targeted Parent-child Communication on Substance Use
18 months - shown information about the dangers · Disagree
101 Participants
115 Participants
122 Participants
122 Participants
Targeted Parent-child Communication on Substance Use
18 months - asked about their thoughts or opinions · Agree
99 Participants
64 Participants
84 Participants
57 Participants
Targeted Parent-child Communication on Substance Use
18 months - asked about their thoughts or opinions · Disagree
58 Participants
87 Participants
76 Participants
102 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Sample sizes differ at each follow-up based on how many parents and children completed the audio submission.

The prompts, modeled after the Family Assessment Task (FAsTask) where parents and adolescents have a conversation about substance use and related behaviors, were developed by the study team (Spirito et al, 2011). The same prompts are used at each time point. The sub-scales (expectations, messaging, communication style, and strategies) range from 1 to 9 (higher values represent a higher quality conversation compared to lower values). The overall combined score ranges from 4 to 36 (higher values represent a higher quality conversation compared to lower values).

Outcome measures

Outcome measures
Measure
Substance Use Prevention Intervention
n=90 Participants
Parents were given a handbook specific to the gender of their child that provides information and advice communication and substance use prevention. Parents then participated in a one-hour session with an interventionist where the main points in the handbook were reviewed and they filled out an action plan on how to make changes in communication about substances with their child. The interventionist also provided parents with a referral packet. Two weeks after the live session, participants had a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents received two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Substance Use Prevention Intervention - Children
n=86 Participants
Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Nutrition, Physical Activity, and Weight Talk Comparison
For the comparison condition, after the baseline assessment, parents received a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Parents also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had the 30-minute call, as well as receive two text messages twice per week for 13 weeks with tips and reminders from the comparison handbook and insert.
Nutrition, Physical Activity, and Weight Talk Comparison - Children
Children discussed with their parents a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert.
Parent-child Audio-recorded Conversations About Substance Use
Messaging
4.7 score
Standard Deviation 1.3
4.6 score
Standard Deviation 1.3
Parent-child Audio-recorded Conversations About Substance Use
Expectations
3.5 score
Standard Deviation 2.1
3.2 score
Standard Deviation 1.9
Parent-child Audio-recorded Conversations About Substance Use
Communication style
5.5 score
Standard Deviation 1.6
5.5 score
Standard Deviation 1.5
Parent-child Audio-recorded Conversations About Substance Use
Strategies
2.4 score
Standard Deviation 1.8
2.2 score
Standard Deviation 1.5
Parent-child Audio-recorded Conversations About Substance Use
Overall combined score
16 score
Standard Deviation 4.0
15.5 score
Standard Deviation 3.5

PRIMARY outcome

Timeframe: 12 months

Population: Sample sizes differ at each follow-up based on how many parents and children completed the video submission.

The mean quality of mealtime interactions is measured using various scales from the Iowa Family Interaction Rating Scales (IFIRS) coding system: Dyadic Interaction Scales, Dyadic Relationship Scales, Group Interactions Scales, and Parenting Scales. Observed behaviors from 3 video-recorded family meals are assessed and scored on a 9-point scale. A higher score indicates coders observed a higher intensity and/or frequency of the construct in the video-recorded family meals. Each IFIRS scale is scored individually, and the average across the 3 family meals is reported. The items were organized into four subscales: Communication (range: 4-36), Parenting Style (range: 5-45), Dyad Relationship (range: 5-45), and Group Enjoyment (range: 1-9).

Outcome measures

Outcome measures
Measure
Substance Use Prevention Intervention
n=90 Participants
Parents were given a handbook specific to the gender of their child that provides information and advice communication and substance use prevention. Parents then participated in a one-hour session with an interventionist where the main points in the handbook were reviewed and they filled out an action plan on how to make changes in communication about substances with their child. The interventionist also provided parents with a referral packet. Two weeks after the live session, participants had a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents received two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Substance Use Prevention Intervention - Children
n=92 Participants
Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Nutrition, Physical Activity, and Weight Talk Comparison
For the comparison condition, after the baseline assessment, parents received a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Parents also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had the 30-minute call, as well as receive two text messages twice per week for 13 weeks with tips and reminders from the comparison handbook and insert.
Nutrition, Physical Activity, and Weight Talk Comparison - Children
Children discussed with their parents a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert.
Quality of Video-recorded Family Mealtime Interactions
Parent communication
28.9 score
Standard Deviation 0.3
28.6 score
Standard Deviation 0.3
Quality of Video-recorded Family Mealtime Interactions
Parenting style
30.3 score
Standard Deviation 0.2
30.1 score
Standard Deviation 0.2
Quality of Video-recorded Family Mealtime Interactions
Dyad relationship
25.7 score
Standard Deviation 0.3
25.8 score
Standard Deviation 0.3
Quality of Video-recorded Family Mealtime Interactions
Group enjoyment
4.5 score
Standard Deviation 0.1
4.2 score
Standard Deviation 0.1

PRIMARY outcome

Timeframe: 18 months

Population: Sample sizes differ based on how many children completed the survey at each follow-up.

Positive and negative expectancies about the affective, cognitive, and behavioral effects of alcohol use will be assessed with the Alcohol Expectancy Questionnaire-Adolescent Form, short version. The tool is comprised of 27 items, each with response options ranging from (1) Strongly Disagree to (6) Strongly Agree. Questions 6, 9, 17, and 26 are scored in opposite direction before they are included in the negative sub-scale (remaining items are included in the positive sub-scale). Sub-scales are created by averaging the items and range from 1 to 6. A higher score on the positive expectancies scale indicates a greater belief that alcohol has desirable effects, and a higher score on the negative expectancies scale indicates a greater belief that alcohol has undesirable effects. This measure was reported by children only.

Outcome measures

Outcome measures
Measure
Substance Use Prevention Intervention
n=129 Participants
Parents were given a handbook specific to the gender of their child that provides information and advice communication and substance use prevention. Parents then participated in a one-hour session with an interventionist where the main points in the handbook were reviewed and they filled out an action plan on how to make changes in communication about substances with their child. The interventionist also provided parents with a referral packet. Two weeks after the live session, participants had a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents received two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Substance Use Prevention Intervention - Children
n=140 Participants
Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Nutrition, Physical Activity, and Weight Talk Comparison
For the comparison condition, after the baseline assessment, parents received a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Parents also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had the 30-minute call, as well as receive two text messages twice per week for 13 weeks with tips and reminders from the comparison handbook and insert.
Nutrition, Physical Activity, and Weight Talk Comparison - Children
Children discussed with their parents a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert.
Child Substance Use Expectancies (Alcohol)
Positive expectancies
2.55 score
Standard Deviation 0.08
2.53 score
Standard Deviation 0.07
Child Substance Use Expectancies (Alcohol)
Negative expectancies
4.24 score
Standard Deviation 0.09
4.23 score
Standard Deviation 0.09

PRIMARY outcome

Timeframe: 18 months

Population: Sample sizes differ based on how many children completed the survey at each follow-up.

Positive and negative expectancies about the affective, cognitive, and behavioral effects of cigarette use will be assessed with the Positive and Negative Outcome Expectancies of Smoking scale. The tool comprises 12 items, each with response options ranging from (1) Strongly Disagree to (6) Strongly Agree. The tool has two subscales (positive expectancies, determined by 7 questions; negative expectancies, determined by 5 questions). Summary scores for both the positive and negative expectancies are created. Summary score values range from 0-7 for positive, 0-5 for negative expectancies. Higher score on positive expectancies scale indicates a greater belief that there are positive outcomes of smoking. Higher score on negative expectancies scale indicates a greater belief in negative consequences of smoking. This measure was reported by children only.

Outcome measures

Outcome measures
Measure
Substance Use Prevention Intervention
n=133 Participants
Parents were given a handbook specific to the gender of their child that provides information and advice communication and substance use prevention. Parents then participated in a one-hour session with an interventionist where the main points in the handbook were reviewed and they filled out an action plan on how to make changes in communication about substances with their child. The interventionist also provided parents with a referral packet. Two weeks after the live session, participants had a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents received two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Substance Use Prevention Intervention - Children
n=143 Participants
Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Nutrition, Physical Activity, and Weight Talk Comparison
For the comparison condition, after the baseline assessment, parents received a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Parents also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had the 30-minute call, as well as receive two text messages twice per week for 13 weeks with tips and reminders from the comparison handbook and insert.
Nutrition, Physical Activity, and Weight Talk Comparison - Children
Children discussed with their parents a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert.
Child Substance Use Expectancies (Cigarettes)
Positive expectancies
1.68 score
Standard Error 0.05
1.57 score
Standard Error 0.05
Child Substance Use Expectancies (Cigarettes)
Negative expectancies
5.15 score
Standard Error 0.07
5.22 score
Standard Error 0.07

PRIMARY outcome

Timeframe: 18 months

Population: Sample sizes differ based on how many children completed the survey at each follow-up.

Positive and negative expectancies about the affective, cognitive, and behavioral effects of marijuana use will be assessed with an adapted version of the Marijuana Effect Expectancies Questionnaire - Brief. The tool comprises three standalone subscales (Relaxation/Tension Reduction, Cognitive/Behavioral Impairment, Global Negative Effects) for a total of 27 items. Each item has responses ranging from (1) Strongly Disagree to (6) Strongly Agree. Scores for each subscale are calculated by averaging item scores within that subscale. Each subscale score range is from 1 - 6. Higher scores on each scale indicate greater expectations positive expectancies (Relaxation/Tension Reduction) and negative expectancies (Cognitive/Behavioral Impairment and Global Negative Effects) associated with marijuana use. This measure was reported by children only.

Outcome measures

Outcome measures
Measure
Substance Use Prevention Intervention
n=128 Participants
Parents were given a handbook specific to the gender of their child that provides information and advice communication and substance use prevention. Parents then participated in a one-hour session with an interventionist where the main points in the handbook were reviewed and they filled out an action plan on how to make changes in communication about substances with their child. The interventionist also provided parents with a referral packet. Two weeks after the live session, participants had a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents received two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Substance Use Prevention Intervention - Children
n=140 Participants
Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Nutrition, Physical Activity, and Weight Talk Comparison
For the comparison condition, after the baseline assessment, parents received a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Parents also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had the 30-minute call, as well as receive two text messages twice per week for 13 weeks with tips and reminders from the comparison handbook and insert.
Nutrition, Physical Activity, and Weight Talk Comparison - Children
Children discussed with their parents a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert.
Child Substance Use Expectancies (Marijuana)
Positive expectancies
2.69 score
Standard Error 0.1
2.73 score
Standard Error 0.1
Child Substance Use Expectancies (Marijuana)
Negative expectancies
4.04 score
Standard Error 0.12
4.16 score
Standard Error 0.12

PRIMARY outcome

Timeframe: 18 months

Population: Sample sizes differ based on how many children completed the survey at each follow-up.

Using an item from the Monitoring the Future study, children will be asked how many of their friends they think use substances. The item is repeated for each substance. This measure was reported by children only.

Outcome measures

Outcome measures
Measure
Substance Use Prevention Intervention
n=148 Participants
Parents were given a handbook specific to the gender of their child that provides information and advice communication and substance use prevention. Parents then participated in a one-hour session with an interventionist where the main points in the handbook were reviewed and they filled out an action plan on how to make changes in communication about substances with their child. The interventionist also provided parents with a referral packet. Two weeks after the live session, participants had a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents received two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Substance Use Prevention Intervention - Children
n=148 Participants
Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Nutrition, Physical Activity, and Weight Talk Comparison
For the comparison condition, after the baseline assessment, parents received a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Parents also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had the 30-minute call, as well as receive two text messages twice per week for 13 weeks with tips and reminders from the comparison handbook and insert.
Nutrition, Physical Activity, and Weight Talk Comparison - Children
Children discussed with their parents a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert.
Child Affiliation With Substance-using Peers
How many of your friends do you think use marijuana? · Some to most
15 Participants
11 Participants
Child Affiliation With Substance-using Peers
How many of your friends do you estimate occassionally drink alcohol? · Some to most
21 Participants
15 Participants
Child Affiliation With Substance-using Peers
How many of your friends do you estimate occassionally drink alcohol? · None
124 Participants
126 Participants
Child Affiliation With Substance-using Peers
How many of your friends do you think smoke cigarettes? · Some to most
11 Participants
4 Participants
Child Affiliation With Substance-using Peers
How many of your friends do you think smoke cigarettes? · None
137 Participants
143 Participants
Child Affiliation With Substance-using Peers
How many of your friends do you think use marijuana? · None
131 Participants
137 Participants
Child Affiliation With Substance-using Peers
How many of your friends do you estimate occassionally use e-cigarettes or vapes? · Some to most
29 Participants
23 Participants
Child Affiliation With Substance-using Peers
How many of your friends do you estimate occassionally use e-cigarettes or vapes? · None
117 Participants
119 Participants
Child Affiliation With Substance-using Peers
How many of your friends do you think use other drugs? · Some to most
4 Participants
2 Participants
Child Affiliation With Substance-using Peers
How many of your friends do you think use other drugs? · None
140 Participants
139 Participants

PRIMARY outcome

Timeframe: 18 months

Population: Sample sizes differ based on how many children completed the survey at each follow-up.

Child willingness to use substances will be assessed through three items adapted from the measure combining intention and willingness originally developed for tobacco and amphetamines found in Gibbons et al. (1998) Reasoned Action and Social Reaction: Willingness and Intention as Independent Predictors of Health Risk. The three items will be asked for each substance. Each item has response options ranging from (1) Not at all likely to (6) Very likely. Response options are transformed to binary format such that 0 represents (1) Not at all likely and 1 represents (2) Unlikely to (6) Very Likely. The three binary items are then averaged for each substance and scores range from 0 to 1 (0 being not willing at all and 1 being somewhat to very likely willing to use the substance). This measure was reported by children only.

Outcome measures

Outcome measures
Measure
Substance Use Prevention Intervention
n=149 Participants
Parents were given a handbook specific to the gender of their child that provides information and advice communication and substance use prevention. Parents then participated in a one-hour session with an interventionist where the main points in the handbook were reviewed and they filled out an action plan on how to make changes in communication about substances with their child. The interventionist also provided parents with a referral packet. Two weeks after the live session, participants had a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents received two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Substance Use Prevention Intervention - Children
n=156 Participants
Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Nutrition, Physical Activity, and Weight Talk Comparison
For the comparison condition, after the baseline assessment, parents received a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Parents also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had the 30-minute call, as well as receive two text messages twice per week for 13 weeks with tips and reminders from the comparison handbook and insert.
Nutrition, Physical Activity, and Weight Talk Comparison - Children
Children discussed with their parents a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert.
Child Willingness to Use Substances
Alcohol - Willingness to use
0.27 score
Standard Deviation 0.64
0.26 score
Standard Deviation 0.63
Child Willingness to Use Substances
Cigarettes - Willingness to use
0.22 score
Standard Deviation 0.61
0.13 score
Standard Deviation 0.41
Child Willingness to Use Substances
Cannabis - Willingness to use
0.24 score
Standard Deviation 0.66
0.15 score
Standard Deviation 0.45
Child Willingness to Use Substances
E-cigarettes or vaping - Willingness to use
0.34 score
Standard Deviation 0.85
0.21 score
Standard Deviation 0.56
Child Willingness to Use Substances
Other drugs - Willingness to use
0.12 score
Standard Deviation 0.44
0.17 score
Standard Deviation 0.49

PRIMARY outcome

Timeframe: 18 months

Population: Sample sizes differ based on how many children completed the survey at each follow-up.

One item from the Youth Alcohol and Drug Survey will assess child's intention to use substances in the next 30 days. The question is asked for each substance and has the response options 'No', 'Probably No', 'Probably Yes', 'Yes'. Response options are dichotomized to (1) No \[which includes 'No' and 'Probably No'\] and (2) Yes \[which includes 'Probably Yes' and 'Yes'\]. This measure was reported by children only.

Outcome measures

Outcome measures
Measure
Substance Use Prevention Intervention
n=147 Participants
Parents were given a handbook specific to the gender of their child that provides information and advice communication and substance use prevention. Parents then participated in a one-hour session with an interventionist where the main points in the handbook were reviewed and they filled out an action plan on how to make changes in communication about substances with their child. The interventionist also provided parents with a referral packet. Two weeks after the live session, participants had a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents received two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Substance Use Prevention Intervention - Children
n=148 Participants
Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Nutrition, Physical Activity, and Weight Talk Comparison
For the comparison condition, after the baseline assessment, parents received a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Parents also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had the 30-minute call, as well as receive two text messages twice per week for 13 weeks with tips and reminders from the comparison handbook and insert.
Nutrition, Physical Activity, and Weight Talk Comparison - Children
Children discussed with their parents a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert.
Child Intentions to Use Substances
Alcohol - Plan to use in the next 30 days · Yes
0 Participants
0 Participants
Child Intentions to Use Substances
Alcohol - Plan to use in the next 30 days · No
147 Participants
146 Participants
Child Intentions to Use Substances
Cigarettes - Plan to use in the next 30 days · Yes
0 Participants
0 Participants
Child Intentions to Use Substances
Cigarettes - Plan to use in the next 30 days · No
147 Participants
148 Participants
Child Intentions to Use Substances
Cannabis - Plan to use in the next 30 days · Yes
0 Participants
0 Participants
Child Intentions to Use Substances
Cannabis - Plan to use in the next 30 days · No
147 Participants
147 Participants
Child Intentions to Use Substances
E-cigarettes or vapes - Plan to use in the next 30 days · Yes
1 Participants
1 Participants
Child Intentions to Use Substances
E-cigarettes or vapes - Plan to use in the next 30 days · No
146 Participants
147 Participants
Child Intentions to Use Substances
Other drugs - Plan to use in the next 30 days · Yes
0 Participants
0 Participants
Child Intentions to Use Substances
Other drugs - Plan to use in the next 30 days · No
144 Participants
140 Participants

SECONDARY outcome

Timeframe: 18 months

Population: Sample sizes differ based on how many children completed the survey at each follow-up.

Substance use initiation for each substance will be assessed with three items from the Drug Use Questionnaire. The items will be asked for each substance. Child responds Yes/No to the "have you ever used \[substance\]?" question. This measure was reported by children only.

Outcome measures

Outcome measures
Measure
Substance Use Prevention Intervention
n=187 Participants
Parents were given a handbook specific to the gender of their child that provides information and advice communication and substance use prevention. Parents then participated in a one-hour session with an interventionist where the main points in the handbook were reviewed and they filled out an action plan on how to make changes in communication about substances with their child. The interventionist also provided parents with a referral packet. Two weeks after the live session, participants had a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents received two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Substance Use Prevention Intervention - Children
n=182 Participants
Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators.
Nutrition, Physical Activity, and Weight Talk Comparison
For the comparison condition, after the baseline assessment, parents received a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Parents also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had the 30-minute call, as well as receive two text messages twice per week for 13 weeks with tips and reminders from the comparison handbook and insert.
Nutrition, Physical Activity, and Weight Talk Comparison - Children
Children discussed with their parents a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert.
Pre/Early-adolescent Substance Use Initiation
Other drugs · Yes
1 Participants
1 Participants
Pre/Early-adolescent Substance Use Initiation
Alcohol · Yes
14 Participants
9 Participants
Pre/Early-adolescent Substance Use Initiation
Alcohol · No
173 Participants
173 Participants
Pre/Early-adolescent Substance Use Initiation
Cigarettes · Yes
3 Participants
2 Participants
Pre/Early-adolescent Substance Use Initiation
Cigarettes · No
184 Participants
180 Participants
Pre/Early-adolescent Substance Use Initiation
Cannabis · Yes
9 Participants
3 Participants
Pre/Early-adolescent Substance Use Initiation
Cannabis · No
178 Participants
179 Participants
Pre/Early-adolescent Substance Use Initiation
E-cigarettes or vaping · Yes
13 Participants
6 Participants
Pre/Early-adolescent Substance Use Initiation
E-cigarettes or vaping · No
174 Participants
176 Participants
Pre/Early-adolescent Substance Use Initiation
Other drugs · No
186 Participants
181 Participants

Adverse Events

Substance Use Prevention Intervention - Parents

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Substance Use Prevention Intervention - Children

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Nutrition, Physical Activity, and Weight Talk Comparison - Parents

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Nutrition, Physical Activity, and Weight Talk Comparison - Children

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Margie Skeer

Tufts University

Phone: 8579191262

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place