Trial Outcomes & Findings for Parent Feedback Intervention Targeting Student Transitions and Alcohol Related Trajectories (+) Efficacy Study (NCT NCT04549454)

Last Updated: 2023-06-01

Results Overview

At baseline and the 1-month follow-up, participants reported the typical quantity of standard alcohol drinks consumed on each day of the week during the past 30 days using the Daily Drinking Questionnaire. Quantity of drinks reported on each day of the week at baseline and 1-month were then summed (separately) to create a composite variable assessing typical weekly drinking at each time point. To compute the outcome, the 1-month measure of typical drinks per week was subtracted from the baseline measure of typical drinks per week such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.

Recruitment status

COMPLETED

Study phase

Target enrollment

266 participants

Primary outcome timeframe

baseline, 1 month

Results posted on

2023-06-01

Participant Flow

The university's admission's office emailed eligible first-year students an invite to take part in a 3-part longitudinal survey study (July 2021). Parents of students who completed the baseline survey were invited via email to join a free online program designed to help them support their student's college transition (Aug 2021). Invited parents were randomized to receive a web URL linking to either the intervention or control version of the program.

Participant milestones

Participant milestones
Measure	Intervention App Students in arm of the study will have a parent who has access to the following content in the parent app: (a) FITSTART+ PBI materials (personalized normative feedback quiz, information on college student drinking, and alcohol-specific advice for parents of first year students); (b) general advice for parents of college students (e.g., improving communication; reducing conflict); (c) information about university resources; and (d) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). FITSTART+ PBI: Personalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice	Control App Students in this arm of the study will have a parent who has access to the following content in the parent app: (a) general advice for parents of college students (e.g., improving communication; reducing conflict); (b) information about university resources; and (c) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). General Parenting Advice: General parenting advice
T1 to T2 STARTED	134	132
T1 to T2 COMPLETED	112	106
T1 to T2 NOT COMPLETED	22	26
T1 to T3 STARTED	134	132
T1 to T3 COMPLETED	103	96
T1 to T3 NOT COMPLETED	31	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention App Students in arm of the study will have a parent who has access to the following content in the parent app: (a) FITSTART+ PBI materials (personalized normative feedback quiz, information on college student drinking, and alcohol-specific advice for parents of first year students); (b) general advice for parents of college students (e.g., improving communication; reducing conflict); (c) information about university resources; and (d) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). FITSTART+ PBI: Personalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice	Control App Students in this arm of the study will have a parent who has access to the following content in the parent app: (a) general advice for parents of college students (e.g., improving communication; reducing conflict); (b) information about university resources; and (c) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). General Parenting Advice: General parenting advice
T1 to T2 Lost to Follow-up	22	26
T1 to T3 Lost to Follow-up	31	36

Baseline Characteristics

Parent Feedback Intervention Targeting Student Transitions and Alcohol Related Trajectories (+) Efficacy Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention App n=134 Participants Students in arm of the study will have a parent who has access to the following content in the parent app: (a) FITSTART+ PBI materials (personalized normative feedback quiz, information on college student drinking, and alcohol-specific advice for parents of first year students); (b) general advice for parents of college students (e.g., improving communication; reducing conflict); (c) information about university resources; and (d) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). FITSTART+ PBI: Personalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice	Control App n=132 Participants Students in this arm of the study will have a parent who has access to the following content in the parent app: (a) general advice for parents of college students (e.g., improving communication; reducing conflict); (b) information about university resources; and (c) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). General Parenting Advice: General parenting advice	Total n=266 Participants Total of all reporting groups
Age, Categorical <=18 years	129 Participants n=5 Participants	124 Participants n=7 Participants	253 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	17.91 years STANDARD_DEVIATION 0.40 • n=5 Participants	17.91 years STANDARD_DEVIATION 0.45 • n=7 Participants	17.91 years STANDARD_DEVIATION 0.42 • n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants	75 Participants n=7 Participants	154 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	57 Participants n=7 Participants	112 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants n=5 Participants	34 Participants n=7 Participants	66 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	102 Participants n=5 Participants	98 Participants n=7 Participants	200 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) White	69 Participants n=5 Participants	72 Participants n=7 Participants	141 Participants n=5 Participants
Race (NIH/OMB) More than one race	32 Participants n=5 Participants	25 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	134 participants n=5 Participants	132 participants n=7 Participants	266 participants n=5 Participants
Typical Weekly Drinking	1.97 Typical alcohol drinks consumed per week STANDARD_DEVIATION 3.70 • n=5 Participants	1.98 Typical alcohol drinks consumed per week STANDARD_DEVIATION 3.78 • n=7 Participants	1.97 Typical alcohol drinks consumed per week STANDARD_DEVIATION 3.74 • n=5 Participants
Consequences	1.34 Types of alcohol consequences STANDARD_DEVIATION 1.96 • n=5 Participants	1.35 Types of alcohol consequences STANDARD_DEVIATION 2.04 • n=7 Participants	1.34 Types of alcohol consequences STANDARD_DEVIATION 2.00 • n=5 Participants
Quantity/Frequency/Peak Alcohol Use	1.78 Peak alcoholic beverages consumed STANDARD_DEVIATION 2.53 • n=5 Participants	2.17 Peak alcoholic beverages consumed STANDARD_DEVIATION 3.16 • n=7 Participants	1.97 Peak alcoholic beverages consumed STANDARD_DEVIATION 2.86 • n=5 Participants
HED	0.42 HED events STANDARD_DEVIATION 1.05 • n=5 Participants	0.56 HED events STANDARD_DEVIATION 1.44 • n=7 Participants	0.49 HED events STANDARD_DEVIATION 1.26 • n=5 Participants

PRIMARY outcome

Timeframe: baseline, 1 month

Outcome measures

Outcome measures
Measure	Intervention App n=111 Participants Students in arm of the study will have a parent who has access to the following content in the parent app: (a) FITSTART+ PBI materials (personalized normative feedback quiz, information on college student drinking, and alcohol-specific advice for parents of first year students); (b) general advice for parents of college students (e.g., improving communication; reducing conflict); (c) information about university resources; and (d) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). FITSTART+ PBI: Personalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice	Control App n=106 Participants Students in this arm of the study will have a parent who has access to the following content in the parent app: (a) general advice for parents of college students (e.g., improving communication; reducing conflict); (b) information about university resources; and (c) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). General Parenting Advice: General parenting advice
Change From Baseline Typical Weekly Drinking at 1 Month	1.67 typical alcohol drinks consumed per week Standard Deviation 3.65	1.82 typical alcohol drinks consumed per week Standard Deviation 3.77

PRIMARY outcome

Timeframe: baseline, 6 months

At baseline and the 6-month follow-up, participants reported the typical quantity of standard alcohol drinks consumed on each day of the week during the past 30 days using the Daily Drinking Questionnaire. Quantity of drinks reported on each day of the week at baseline and 1-month were then summed (separately) to create a composite variable assessing typical weekly drinking at each time point. To compute the outcome, the 6-month measure of typical drinks per week was subtracted from the baseline measure of typical drinks per week such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.

Outcome measures

Outcome measures
Measure	Intervention App n=103 Participants Students in arm of the study will have a parent who has access to the following content in the parent app: (a) FITSTART+ PBI materials (personalized normative feedback quiz, information on college student drinking, and alcohol-specific advice for parents of first year students); (b) general advice for parents of college students (e.g., improving communication; reducing conflict); (c) information about university resources; and (d) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). FITSTART+ PBI: Personalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice	Control App n=94 Participants Students in this arm of the study will have a parent who has access to the following content in the parent app: (a) general advice for parents of college students (e.g., improving communication; reducing conflict); (b) information about university resources; and (c) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). General Parenting Advice: General parenting advice
Change From Baseline Typical Weekly Drinking at 6 Months	2.31 typical alcohol drinks consumed per week Standard Deviation 5.20	2.21 typical alcohol drinks consumed per week Standard Deviation 4.44

PRIMARY outcome

Timeframe: baseline, 1 month

At baseline and the 1-month follow-up, the number of types of negative alcohol-related consequences experienced out of a list of 14 common negative alcohol-related consequences (past 30 days) were summed to create a composite variable at each time point. To compute the outcome, the 1-month measure of negative consequences was subtracted from the baseline measure of negative consequences such that a positive value indicates a decrease in consequences during this period and a negative value indicates an increase in consequences during this period.

Outcome measures

Outcome measures
Measure	Intervention App n=112 Participants Students in arm of the study will have a parent who has access to the following content in the parent app: (a) FITSTART+ PBI materials (personalized normative feedback quiz, information on college student drinking, and alcohol-specific advice for parents of first year students); (b) general advice for parents of college students (e.g., improving communication; reducing conflict); (c) information about university resources; and (d) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). FITSTART+ PBI: Personalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice	Control App n=105 Participants Students in this arm of the study will have a parent who has access to the following content in the parent app: (a) general advice for parents of college students (e.g., improving communication; reducing conflict); (b) information about university resources; and (c) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). General Parenting Advice: General parenting advice
Change From Baseline Frequency of Alcohol Consequences at 1 Month	0.24 types of alcohol consequences Standard Deviation 1.71	0.28 types of alcohol consequences Standard Deviation 2.22

PRIMARY outcome

Timeframe: baseline, 6 months

At baseline and the 6-month follow-up, the number of types of negative alcohol-related consequences experienced out of a list of 14 common negative alcohol-related consequences (past 30 days) were summed to create a composite variable at each time point. To compute the outcome, the 6-month measure of negative consequences was subtracted from the baseline measure of negative consequences such that a positive value indicates a decrease in consequences during this period and a negative value indicates an increase in consequences during this period.

Outcome measures

Outcome measures
Measure	Intervention App n=103 Participants Students in arm of the study will have a parent who has access to the following content in the parent app: (a) FITSTART+ PBI materials (personalized normative feedback quiz, information on college student drinking, and alcohol-specific advice for parents of first year students); (b) general advice for parents of college students (e.g., improving communication; reducing conflict); (c) information about university resources; and (d) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). FITSTART+ PBI: Personalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice	Control App n=96 Participants Students in this arm of the study will have a parent who has access to the following content in the parent app: (a) general advice for parents of college students (e.g., improving communication; reducing conflict); (b) information about university resources; and (c) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). General Parenting Advice: General parenting advice
Change From Baseline Frequency of Alcohol Consequences at 6 Months	.52 types of alcohol consequences Standard Deviation 2.84	.73 types of alcohol consequences Standard Deviation 3.30

PRIMARY outcome

Timeframe: baseline, 1 month

At baseline and the 1-month follow-up, an item assessing the number of maximum drinks on one occasion from the Frequency, Quantity, Max (FQM) measure was used to assess peak drinks on one occasion over the past 30 days. To compute the outcome, the 1-month measure of peak drinks was subtracted from the baseline measure of peak drinks such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.

Outcome measures

Outcome measures
Measure	Intervention App n=111 Participants Students in arm of the study will have a parent who has access to the following content in the parent app: (a) FITSTART+ PBI materials (personalized normative feedback quiz, information on college student drinking, and alcohol-specific advice for parents of first year students); (b) general advice for parents of college students (e.g., improving communication; reducing conflict); (c) information about university resources; and (d) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). FITSTART+ PBI: Personalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice	Control App n=106 Participants Students in this arm of the study will have a parent who has access to the following content in the parent app: (a) general advice for parents of college students (e.g., improving communication; reducing conflict); (b) information about university resources; and (c) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). General Parenting Advice: General parenting advice
Change From Baseline Quantity/Frequency/Peak Alcohol Use at 1 Month	.91 Peak alcoholic beverages consumed Standard Deviation 2.46	.98 Peak alcoholic beverages consumed Standard Deviation 2.63

PRIMARY outcome

Timeframe: baseline, 6 months

At baseline and the 6-month follow-up, an item assessing the number of maximum drinks on one occasion from the Frequency, Quantity, Max (FQM) measure was used to assess peak drinks on one occasion over the past 30 days. To compute the outcome, the 6-month measure of peak drinks was subtracted from the baseline measure of peak drinks such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.

Outcome measures

Outcome measures
Measure	Intervention App n=103 Participants Students in arm of the study will have a parent who has access to the following content in the parent app: (a) FITSTART+ PBI materials (personalized normative feedback quiz, information on college student drinking, and alcohol-specific advice for parents of first year students); (b) general advice for parents of college students (e.g., improving communication; reducing conflict); (c) information about university resources; and (d) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). FITSTART+ PBI: Personalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice	Control App n=95 Participants Students in this arm of the study will have a parent who has access to the following content in the parent app: (a) general advice for parents of college students (e.g., improving communication; reducing conflict); (b) information about university resources; and (c) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). General Parenting Advice: General parenting advice
Change From Baseline Quantity/Frequency/Peak Alcohol Use at 6 Months	1.54 Peak alcoholic beverages consumed Standard Deviation 3.43	1.36 Peak alcoholic beverages consumed Standard Deviation 3.25

PRIMARY outcome

Timeframe: baseline, 1 month

At baseline and the 1-month follow-up, an item assessing the number of times students reported a heavy episodic drinking (HED) event in the past two weeks. To compute the outcome, the 1-month measure of HED was subtracted from the baseline measure of HED such that a positive value indicates a decrease in HED events during this period and a negative value indicates an increase in HED events during this period.

Outcome measures

Outcome measures
Measure	Intervention App n=111 Participants Students in arm of the study will have a parent who has access to the following content in the parent app: (a) FITSTART+ PBI materials (personalized normative feedback quiz, information on college student drinking, and alcohol-specific advice for parents of first year students); (b) general advice for parents of college students (e.g., improving communication; reducing conflict); (c) information about university resources; and (d) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). FITSTART+ PBI: Personalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice	Control App n=106 Participants Students in this arm of the study will have a parent who has access to the following content in the parent app: (a) general advice for parents of college students (e.g., improving communication; reducing conflict); (b) information about university resources; and (c) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). General Parenting Advice: General parenting advice
Change From Baseline Heavy Episodic Drinking at 1 Month	.41 HED events Standard Deviation 1.27	.47 HED events Standard Deviation 1.44

PRIMARY outcome

Timeframe: baseline, 6 months

Outcome measures

Outcome measures
Measure	Intervention App n=103 Participants Students in arm of the study will have a parent who has access to the following content in the parent app: (a) FITSTART+ PBI materials (personalized normative feedback quiz, information on college student drinking, and alcohol-specific advice for parents of first year students); (b) general advice for parents of college students (e.g., improving communication; reducing conflict); (c) information about university resources; and (d) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). FITSTART+ PBI: Personalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice	Control App n=96 Participants Students in this arm of the study will have a parent who has access to the following content in the parent app: (a) general advice for parents of college students (e.g., improving communication; reducing conflict); (b) information about university resources; and (c) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). General Parenting Advice: General parenting advice
Change From Baseline Heavy Episodic Drinking at 6 Months	.67 HED events Standard Deviation 1.67	.56 HED events Standard Deviation 1.50

Adverse Events

Intervention App

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control App

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. Bradley Trager, Research Scientist

Loyola Marymount University

Phone: 3103385238

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place