An interventional study of Interactive Social Networking Site Parent Based Intervention and Active Control in Underage Drinking, sponsored by University of North Texas Health Science Center. Completed at 1 site in United States. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-24.
Sponsored by University of North Texas Health Science Center · Not applicable, Interventional, and Prevention
The prevalence of underage alcohol use continues to be a public health concern. Numerous studies have reported associations between teen drinking tendencies and parental attitudes and beliefs, parental awareness of teen drinking, parental monitoring and the quality of the parent-teen relationship and communication. The extensive work in this area has resulted in parent-based intervention (PBI) efforts to prevent or reduce adolescent alcohol use. Several independent studies have indicated that teens whose parents received a PBI reported less alcohol use and fewer alcohol-related consequences. Despite these strengths, one major limitation of PBI is that they do not currently take into account the large role that social networking sites (SNS) use plays in adolescents' lives and in relation to their alcohol use. Most (90%) adolescents are on SNS, and their Facebook, Instagram, and Twitter profiles include alcohol content. Thus, adolescents are making and exposed to SNS alcohol displays and these displays are associated with high-risk drinking cognitions and alcohol use. As such, the investigators propose to develop and refine an interactive PBI designed to reduce high-risk SNS cognitions (i.e. attitudes and norms), alcohol use, and negative consequences among adolescents. To achieve study aims, the investigators propose an iterative process of focus groups in order to develop and refine the interactive PBI to be delivered in the pilot study with 1 and 6-month follow-up among 100 parent/teen dyads. The objective of this R34 application is to establish feasibility and acceptability of the newly developed interactive PBI that focuses on the role of SNS in adolescent alcohol use as well as to determine preliminary effect sizes for future studies. Determining an efficacious way to reduce alcohol use and high-risk alcohol display cognitions affords future research the opportunity to make use of social network-based interventions, thus the proposed research has great potential to serve as a catalyst for future research.
Although adolescents spend an increasing amount of time with their friends, parents remain an important source of support and continue to play a key role in the lives of their adolescents. The extensive work in this area has resulted in parent based intervention (PBI) efforts to prevent or reduce adolescent alcohol use. Research has shown that teens whose parents received a PBI reported less alcohol use and fewer alcohol related consequences up to 9-month follow-up relative to controls. However, one major limitation of PBIs is that they do not currently take into account the large role that social networking sites (SNS) play in adolescents' lives and in relation to their alcohol use. Most (90%) adolescents are on SNS, and their Facebook, Instagram, and Twitter profiles include alcohol content. Thus, adolescents are making and exposed to SNS alcohol displays, and these displays are associated with high-risk cognitions and alcohol use. Research has argued that existing parental mediation techniques grounded primarily on television/film media have fundamental inadequacies when applied to more interactive media such as websites, social media, and mobile apps as they do not account for the interactivity, immersive virtual environments, and mediated communication innate to SNS. Further, most PBIs are presented in static manual form. The investigators are unaware of any study to date that has developed and tested an interactive PBI about alcohol use and the role of SNS in adolescent alcohol use. As such, the investigators propose to develop and refine an interactive PBI designed to reduce both high-risk SNS cognitions and alcohol use among adolescents. This application responds to PA-18-067 "Pilot and Feasibility Studies in Preparation for Drug and Alcohol Abuse Prevention Trials" as it aims to establish feasibility and acceptability of the newly developed interactive PBI that focuses on the role of SNS in adolescent alcohol use as well as to determine preliminary effect sizes for future studies. The specific aims are as follows: Aim 1: Develop and refine an interactive PBI targeting the influence of SNS on high-risk SNS cognitions and alcohol use among adolescents. Interactive PBI content and text message prompts will be developed through focus groups, which will inform a new interactive PBI to be tested in a pilot study (Aim 2). A total of 16 focus groups (8 parent, 8 teen) will be conducted with 8-10 people in each group with parents only being in focus groups with other parents and teens being only with other teens. Focus groups will occur in two phases whereby an initial sample of participants (4 parent and 4 teen focus groups) will engage in parent and teen specific focus groups (split by age of teen-15-17 and 18-20) in which they will be asked to view and interact with the interactive SNS PBI and generate additional PBI content. Based on focus group data from the first round of focus groups, revisions will be made for use in the remaining 8 focus groups (4 parent, 4 teen). Aim 2: Conduct a pilot study with parents and their adolescents aged 15-20 from the Dallas/Fort Worth (DFW) area to determine feasibility, acceptability, and preliminary effect sizes (to estimate power and sample size for a future R01 application). Parent/teen dyads (N=100) will be randomized to interactive PBI (n=50) or active control (n=50) with a 1- and 6-month follow-up. Parents in the interactive PBI condition will receive the interactive web-based SNS PBI with text message prompts developed and finalized through Aim 1 focus groups. Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families. General Hypotheses (parent and teen). The investigators hypothesize that the interactive SNS PBI will be feasible (i.e., number of eligible participants, number of parents who gave consent, number of teens who gave consent, length of time to achieve planned recruitment and enrollment goal, rate of study completion and rate of study attrition) and acceptable (i.e., proportion of parents and teens who find the intervention acceptable; ease of viewing and interacting with interactive PBI content; relevance of material; finding content helpful, beneficial, important; ratings of individual web-based modules and text messages of the PBI; the proportion of parents and teens who would recommend the study to other families, and the proportion of parents and teens who found the interactive PBI to be favorable overall) relative to active control. The investigators further hypothesize that teens and parents in the interactive PBI condition will report more positive communication about alcohol and SNS at the 1- and 6-month follow-up relative to active control. Parent Hypotheses: The investigators hypothesize that at 1- and 6-month follow-up, parents in the interactive PBI condition will report greater knowledge about alcohol as well as the role of SNS in alcohol use relative to active control. Teen Hypotheses: The investigators hypothesize that teens in the interactive PBI condition will report less drinking, fewer alcohol-related negative consequences, less favorable attitudes toward posting about alcohol on SNS, greater perceived vulnerability to the risks of posting alcohol displays on SNS, and decreased normative perceptions about how many teens post alcohol displays on SNS relative to active control at 1- and 6-month follow-up.
44 studies on the registry are indexed under Underage Drinking; 13 are open to participants now.
This study's enrollment of 202 is below the median of 360 across 43 interventional studies indexed under Underage Drinking.
Browse Underage Drinking studies →University of North Texas Health Science Center is the lead sponsor of 31 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (Parents):
Inclusion Criteria (Teens):
Exclusion Criteria:
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.
Behavioral: Interactive Social Networking Site Parent Based Intervention
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families.
Behavioral: Active Control
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 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
Percentage of parents in the interactive PBI condition who agreed or strongly agreed that the program was useful
Time frame: Data will be collected at 1 month follow-up
Acceptability (Parent)- Relationship
Percentage of parents assigned to Interactive PBI who agreed or strongly agreed that the program helped their relationship with their teen
Time frame: Data will be collected at 1 month follow-up
Acceptability (Teen)- Relationship
Percentage of teens assigned to interactive PBI who agreed or strongly agreed that the program helped their relationship with their parent
Time frame: Data will be collected at 1 month follow-up
Acceptability (Teen)- Percentage Who Would Recommend the Program
Percentage of teens assigned to the interactive PBI who would recommend the program
Time frame: Data will be collected at 1 month follow-up
Acceptability (Parent)- Percentage Who Would Recommend the Program
Percentage of parents assigned to interactive PBI who would recommend the program
Time frame: Data will be collected at 1 month follow-up
Drinking Days in Past Month (Teen)
Number of drinking days in the past month.
Time frame: Data will be collected at 1 month follow-up
Drinking Days in Past Month (Teen)
Number of drinking days in the past month.
Time frame: Data will be collected at 6 month follow-up
Communication About Alcohol and Social Media (Parent)
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.
Time frame: Data will be collected at 1 month follow-up
Communication About Alcohol and Social Media (Parent)
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.
Time frame: Data will be collected at 6 month follow-up
Communication About Alcohol and Social Media (Teen)
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.
Time frame: Data will be collected at 1 month follow-up
Communication About Alcohol and Social Media (Teen)
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.
Time frame: Data will be collected at 6 month follow-up
| Milestone | Interactive PBI | Active Control |
|---|---|---|
| Started | 100 | 102 |
| Parents started | 50 | 51 |
| Teens who started | 50 | 51 |
| Teen completed | 41 | 42 |
| Parent completed | 48 | 47 |
| Completed | 90 | 89 |
| Not completed | 10 | 13 |
Percentage of parents in the interactive PBI condition who agreed or strongly agreed that the program was useful
| Participants | Interactive PBI |
|---|---|
| Acceptability (Parent)- Program Usefulness | 42 |
Percentage of parents assigned to Interactive PBI who agreed or strongly agreed that the program helped their relationship with their teen
| Participants | Interactive PBI |
|---|---|
| Acceptability (Parent)- Relationship | 45 |
Percentage of teens assigned to interactive PBI who agreed or strongly agreed that the program helped their relationship with their parent
| Participants | Interactive PBI |
|---|---|
| Acceptability (Teen)- Relationship | 41 |
Percentage of teens assigned to the interactive PBI who would recommend the program
| Participants | Interactive PBI |
|---|---|
| Acceptability (Teen)- Percentage Who Would Recommend the Program | 45 |
Percentage of parents assigned to interactive PBI who would recommend the program
| Participants | Interactive PBI |
|---|---|
| Acceptability (Parent)- Percentage Who Would Recommend the Program | 45 |
Number of drinking days in the past month.
| Number of days | Interactive PBI | Active Control |
|---|---|---|
| Drinking Days in Past Month (Teen) | 0.24 ± 0.88 | 0.26 ± 0.86 |
Number of drinking days in the past month.
| number of days | Interactive PBI | Active Control |
|---|---|---|
| Drinking Days in Past Month (Teen) | 0.18 ± 0.51 | 0.76 ± 2.36 |
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.
| units on a scale | Interactive PBI | Active Control |
|---|---|---|
| Communication About Alcohol and Social Media (Parent) | 2.03 ± 0.68 | 1.79 ± 0.64 |
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.
| units on a scale | Interactive PBI | Active Control |
|---|---|---|
| Communication About Alcohol and Social Media (Parent) | 1.80 ± 0.80 | 1.66 ± 0.66 |
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.
| units on a scale | Interactive PBI | Active Control |
|---|---|---|
| Communication About Alcohol and Social Media (Teen) | 1.65 ± 0.68 | 1.53 ± 0.61 |
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.
| units on a scale | Interactive PBI | Active Control |
|---|---|---|
| Communication About Alcohol and Social Media (Teen) | 1.48 ± 0.53 | 1.33 ± 0.48 |
Collected over Adverse event data was collected over the life of study participation, which was 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Interactive PBI | 0/100 (0%) | 0/100 (0%) | 0/100 (0%) |
| Active Control | 0/102 (0%) | 0/102 (0%) | 0/102 (0%) |
Fully enrolled participants include those dyads where both parent and teen completed baseline. Numbers presented are for parents and teens combined (total number of participants).
| Age, Categorical(Participants) | Interactive PBI (Parents and Teens Combined) | Control Condition (Parents and Teens Combined) | Total |
|---|---|---|---|
| Teens — <=18 years | 40 | 46 | 86 |
| Teens — Between 18 and 65 years | 10 | 5 | 15 |
| Teens — >=65 years | 0 | 0 | 0 |
| Parents — <=18 years | 0 | 0 | 0 |
| Parents — Between 18 and 65 years | 50 | 51 | 101 |
| Parents — >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Interactive PBI (Parents and Teens Combined) | Control Condition (Parents and Teens Combined) | Total |
|---|---|---|---|
| Teens — Female | 26 | 28 | 54 |
| Teens — Male | 24 | 23 | 47 |
| Parents — Female | 41 | 43 | 84 |
| Parents — Male | 9 | 8 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Interactive PBI (Parents and Teens Combined) | Control Condition (Parents and Teens Combined) | Total |
|---|---|---|---|
| Teens — Hispanic or Latino | 16 | 33 | 49 |
| Teens — Not Hispanic or Latino | 32 | 15 | 47 |
| Teens — Unknown or Not Reported | 2 | 3 | 5 |
| Parents — Hispanic or Latino | 13 | 33 | 46 |
| Parents — Not Hispanic or Latino | 37 | 18 | 55 |
| Parents — Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Interactive PBI (Parents and Teens Combined) | Control Condition (Parents and Teens Combined) | Total |
|---|---|---|---|
| Parents — American Indian or Alaska Native | 0 | 1 | 1 |
| Parents — Asian | 6 | 2 | 8 |
| Parents — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Parents — Black or African American | 13 | 12 | 25 |
| Parents — White | 29 | 31 | 60 |
| Parents — More than one race | 2 | 3 | 5 |
| Parents — Unknown or Not Reported | 0 | 2 | 2 |
| Teens — American Indian or Alaska Native | 0 | 1 | 1 |
| Teens — Asian | 9 | 4 | 13 |
| Teens — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Teens — Black or African American | 7 | 12 | 19 |
| Teens — White | 26 | 28 | 54 |
| Teens — More than one race | 4 | 5 | 9 |
| Teens — Unknown or Not Reported | 4 | 1 | 5 |
| Region of Enrollment(participants) | Interactive PBI (Parents and Teens Combined) | Control Condition (Parents and Teens Combined) | Total |
|---|---|---|---|
| United States | 100 | 102 | 0 |
| Drinking Days per Month(days) | Interactive PBI (Parents and Teens Combined) | Control Condition (Parents and Teens Combined) | Total |
|---|---|---|---|
| Mean | 0.15 ± 0.65 | 0.22 ± 0.62 | 0.18 ± 0.63 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — A select number of researchers will have access to unidentified participant data at the close of the study.
Ran from Feb 2023 to primary completion in Mar 2024, 13 months.
Results were first posted in Oct 2024, 7 months after primary completion.
Of 34 non-industry interventional studies with no phase under Underage Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 38. This study's 13 months is below that.
Counting every sponsor, half of 36 studies reached it within 24 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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University of North Texas Health Science Center