Trial Outcomes & Findings for Parental Research on Interventions for Social Media (NCT NCT04333966)

NCT ID: NCT04333966

Last Updated: 2024-10-24

Results Overview

Percentage of parents in the interactive PBI condition who agreed or strongly agreed that the program was useful

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

202 participants

Primary outcome timeframe

Data will be collected at 1 month follow-up

Results posted on

2024-10-24

Participant Flow

Only parent and teen dyads and who had both completed baseline were considered enrolled. The numbers in each milestone represent the total number of participants (parents and teens combined).

Participant milestones

Participant milestones
Measure
Interactive PBI
Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS. Interactive Social Networking Site Parent Based Intervention: Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS. Both parents and teens completed baseline, 1, and 6 month follow-up.
Active Control
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families. Active Control: Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families. Both parents and teens completed baseline, 1, and 6 month follow-up.
Overall Study
STARTED
100
102
Overall Study
Parents Started
50
51
Overall Study
Teens Who Started
50
51
Overall Study
Teen Completed
41
42
Overall Study
Parent Completed
48
47
Overall Study
COMPLETED
90
89
Overall Study
NOT COMPLETED
10
13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data are being reported separately for the parents and their teens/

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Interactive PBI (Parents and Teens Combined)
n=100 Participants
Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS. Interactive Social Networking Site Parent Based Intervention: Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS. Parents and teens completed both baseline, 1 month, and 6-month follow-up. Baseline measure sample sizes are presented for parents and teens combined for each arm.
Control Condition (Parents and Teens Combined)
n=102 Participants
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families. Active Control: Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families. Parents and teens completed both baseline, 1 month, and 6-month follow-up. Baseline measure sample sizes are presented for parents and teens combined for each arm.
Total
n=202 Participants
Total of all reporting groups
Age, Categorical
Teens · <=18 years
40 Participants
n=50 Participants • Data are being reported separately for the parents and their teens/
46 Participants
n=51 Participants • Data are being reported separately for the parents and their teens/
86 Participants
n=101 Participants • Data are being reported separately for the parents and their teens/
Age, Categorical
Teens · Between 18 and 65 years
10 Participants
n=50 Participants • Data are being reported separately for the parents and their teens/
5 Participants
n=51 Participants • Data are being reported separately for the parents and their teens/
15 Participants
n=101 Participants • Data are being reported separately for the parents and their teens/
Age, Categorical
Teens · >=65 years
0 Participants
n=50 Participants • Data are being reported separately for the parents and their teens/
0 Participants
n=51 Participants • Data are being reported separately for the parents and their teens/
0 Participants
n=101 Participants • Data are being reported separately for the parents and their teens/
Age, Categorical
Parents · <=18 years
0 Participants
n=50 Participants • Data are being reported separately for the parents and their teens/
0 Participants
n=51 Participants • Data are being reported separately for the parents and their teens/
0 Participants
n=101 Participants • Data are being reported separately for the parents and their teens/
Age, Categorical
Parents · Between 18 and 65 years
50 Participants
n=50 Participants • Data are being reported separately for the parents and their teens/
51 Participants
n=51 Participants • Data are being reported separately for the parents and their teens/
101 Participants
n=101 Participants • Data are being reported separately for the parents and their teens/
Age, Categorical
Parents · >=65 years
0 Participants
n=50 Participants • Data are being reported separately for the parents and their teens/
0 Participants
n=51 Participants • Data are being reported separately for the parents and their teens/
0 Participants
n=101 Participants • Data are being reported separately for the parents and their teens/
Sex: Female, Male
Teens · Female
26 Participants
n=50 Participants • Data are being reported separately for the parents and their teens
28 Participants
n=51 Participants • Data are being reported separately for the parents and their teens
54 Participants
n=101 Participants • Data are being reported separately for the parents and their teens
Sex: Female, Male
Teens · Male
24 Participants
n=50 Participants • Data are being reported separately for the parents and their teens
23 Participants
n=51 Participants • Data are being reported separately for the parents and their teens
47 Participants
n=101 Participants • Data are being reported separately for the parents and their teens
Sex: Female, Male
Parents · Female
41 Participants
n=50 Participants • Data are being reported separately for the parents and their teens
43 Participants
n=51 Participants • Data are being reported separately for the parents and their teens
84 Participants
n=101 Participants • Data are being reported separately for the parents and their teens
Sex: Female, Male
Parents · Male
9 Participants
n=50 Participants • Data are being reported separately for the parents and their teens
8 Participants
n=51 Participants • Data are being reported separately for the parents and their teens
17 Participants
n=101 Participants • Data are being reported separately for the parents and their teens
Ethnicity (NIH/OMB)
Teens · Hispanic or Latino
16 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
33 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
49 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Ethnicity (NIH/OMB)
Teens · Not Hispanic or Latino
32 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
15 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
47 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Ethnicity (NIH/OMB)
Teens · Unknown or Not Reported
2 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
3 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
5 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Ethnicity (NIH/OMB)
Parents · Hispanic or Latino
13 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
33 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
46 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Ethnicity (NIH/OMB)
Parents · Not Hispanic or Latino
37 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
18 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
55 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Ethnicity (NIH/OMB)
Parents · Unknown or Not Reported
0 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
0 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
0 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Race (NIH/OMB)
Parents · American Indian or Alaska Native
0 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
1 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
1 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Race (NIH/OMB)
Parents · Asian
6 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
2 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
8 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Race (NIH/OMB)
Parents · Native Hawaiian or Other Pacific Islander
0 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
0 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
0 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Race (NIH/OMB)
Parents · Black or African American
13 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
12 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
25 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Race (NIH/OMB)
Parents · White
29 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
31 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
60 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Race (NIH/OMB)
Parents · More than one race
2 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
3 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
5 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Race (NIH/OMB)
Parents · Unknown or Not Reported
0 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
2 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
2 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Race (NIH/OMB)
Teens · American Indian or Alaska Native
0 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
1 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
1 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Race (NIH/OMB)
Teens · Asian
9 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
4 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
13 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Race (NIH/OMB)
Teens · Native Hawaiian or Other Pacific Islander
0 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
0 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
0 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Race (NIH/OMB)
Teens · Black or African American
7 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
12 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
19 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Race (NIH/OMB)
Teens · White
26 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
28 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
54 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Race (NIH/OMB)
Teens · More than one race
4 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
5 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
9 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Race (NIH/OMB)
Teens · Unknown or Not Reported
4 Participants
n=50 Participants • Data are being reported separately for parents and their teens.
1 Participants
n=51 Participants • Data are being reported separately for parents and their teens.
5 Participants
n=101 Participants • Data are being reported separately for parents and their teens.
Region of Enrollment
United States
100 participants
n=100 Participants
102 participants
n=102 Participants
0 participants
n=202 Participants
Drinking Days per Month
0.15 days
STANDARD_DEVIATION 0.65 • n=50 Participants • This outcome was only assessed for the teens, and thus is half of the overall enrollment number.
0.22 days
STANDARD_DEVIATION 0.62 • n=51 Participants • This outcome was only assessed for the teens, and thus is half of the overall enrollment number.
0.18 days
STANDARD_DEVIATION 0.63 • n=101 Participants • This outcome was only assessed for the teens, and thus is half of the overall enrollment number.

PRIMARY outcome

Timeframe: Data will be collected at 1 month follow-up

Population: Only parents in the interactive PBI condition received this item.

Percentage of parents in the interactive PBI condition who agreed or strongly agreed that the program was useful

Outcome measures

Outcome measures
Measure
Interactive PBI
n=49 Participants
Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS. Interactive Social Networking Site Parent Based Intervention: Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS.
Active Control
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families. Active Control: Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families.
Acceptability (Parent)- Program Usefulness
42 Participants

PRIMARY outcome

Timeframe: Data will be collected at 1 month follow-up

Population: Only parents assigned to interactive PBI received this item

Percentage of parents assigned to Interactive PBI who agreed or strongly agreed that the program helped their relationship with their teen

Outcome measures

Outcome measures
Measure
Interactive PBI
n=49 Participants
Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS. Interactive Social Networking Site Parent Based Intervention: Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS.
Active Control
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families. Active Control: Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families.
Acceptability (Parent)- Relationship
45 Participants

PRIMARY outcome

Timeframe: Data will be collected at 1 month follow-up

Population: Only participants assigned to interactive PBI received this item

Percentage of teens assigned to interactive PBI who agreed or strongly agreed that the program helped their relationship with their parent

Outcome measures

Outcome measures
Measure
Interactive PBI
n=47 Participants
Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS. Interactive Social Networking Site Parent Based Intervention: Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS.
Active Control
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families. Active Control: Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families.
Acceptability (Teen)- Relationship
41 Participants

PRIMARY outcome

Timeframe: Data will be collected at 1 month follow-up

Population: Only participants assigned to interactive PBI received this item.

Percentage of teens assigned to the interactive PBI who would recommend the program

Outcome measures

Outcome measures
Measure
Interactive PBI
n=47 Participants
Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS. Interactive Social Networking Site Parent Based Intervention: Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS.
Active Control
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families. Active Control: Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families.
Acceptability (Teen)- Percentage Who Would Recommend the Program
45 Participants

PRIMARY outcome

Timeframe: Data will be collected at 1 month follow-up

Population: Only participants assigned to interactive PBI received this item.

Percentage of parents assigned to interactive PBI who would recommend the program

Outcome measures

Outcome measures
Measure
Interactive PBI
n=49 Participants
Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS. Interactive Social Networking Site Parent Based Intervention: Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS.
Active Control
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families. Active Control: Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families.
Acceptability (Parent)- Percentage Who Would Recommend the Program
45 Participants

SECONDARY outcome

Timeframe: Data will be collected at 1 month follow-up

Population: Only those participants who completed the 1-month follow-up were analyzed.

Number of drinking days in the past month.

Outcome measures

Outcome measures
Measure
Interactive PBI
n=45 Participants
Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS. Interactive Social Networking Site Parent Based Intervention: Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS.
Active Control
n=46 Participants
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families. Active Control: Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families.
Drinking Days in Past Month (Teen)
0.24 Number of days
Standard Deviation 0.88
0.26 Number of days
Standard Deviation 0.86

SECONDARY outcome

Timeframe: Data will be collected at 6 month follow-up

Population: Only participants who completed 6 month follow-up were analyzed

Number of drinking days in the past month.

Outcome measures

Outcome measures
Measure
Interactive PBI
n=39 Participants
Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS. Interactive Social Networking Site Parent Based Intervention: Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS.
Active Control
n=37 Participants
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families. Active Control: Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families.
Drinking Days in Past Month (Teen)
0.18 number of days
Standard Deviation 0.51
0.76 number of days
Standard Deviation 2.36

SECONDARY outcome

Timeframe: Data will be collected at 1 month follow-up

Population: All parents who completed the 1-month followup survey.

Extent to which parent spoke to teen about alcohol and social media in past month ranging from 1 = not at all to 4 = a great deal.

Outcome measures

Outcome measures
Measure
Interactive PBI
n=50 Participants
Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS. Interactive Social Networking Site Parent Based Intervention: Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS.
Active Control
n=51 Participants
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families. Active Control: Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families.
Communication About Alcohol and Social Media (Parent)
2.03 units on a scale
Standard Deviation 0.68
1.79 units on a scale
Standard Deviation 0.64

SECONDARY outcome

Timeframe: Data will be collected at 6 month follow-up

Population: All parents who completed 6-month followup

Extent to which parent spoke to teen about alcohol and social media in past month from 1= not at all to 4= a great deal.

Outcome measures

Outcome measures
Measure
Interactive PBI
n=49 Participants
Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS. Interactive Social Networking Site Parent Based Intervention: Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS.
Active Control
n=47 Participants
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families. Active Control: Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families.
Communication About Alcohol and Social Media (Parent)
1.80 units on a scale
Standard Deviation 0.80
1.66 units on a scale
Standard Deviation 0.66

SECONDARY outcome

Timeframe: Data will be collected at 1 month follow-up

Population: All teens who completed 1-month follow-up

Extent to which teen spoke to teen about alcohol and social media in past month from 1= not at all to 4 = a great deal.

Outcome measures

Outcome measures
Measure
Interactive PBI
n=49 Participants
Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS. Interactive Social Networking Site Parent Based Intervention: Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS.
Active Control
n=48 Participants
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families. Active Control: Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families.
Communication About Alcohol and Social Media (Teen)
1.65 units on a scale
Standard Deviation 0.68
1.53 units on a scale
Standard Deviation 0.61

SECONDARY outcome

Timeframe: Data will be collected at 6 month follow-up

Population: All teens who completed 6-month follow-up.

Extent to which teen spoke to teen about alcohol and social media in past month from 1= not at all to 4= a great deal.

Outcome measures

Outcome measures
Measure
Interactive PBI
n=44 Participants
Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS. Interactive Social Networking Site Parent Based Intervention: Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS.
Active Control
n=44 Participants
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families. Active Control: Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families.
Communication About Alcohol and Social Media (Teen)
1.48 units on a scale
Standard Deviation 0.53
1.33 units on a scale
Standard Deviation 0.48

Adverse Events

Interactive PBI

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

Active Control

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. Dana Litt

University of North Texas Health Science Center

Phone: 817-735-5453

Results disclosure agreements

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