Clinical trial NCT04333966: Parental Research on Interventions for Social Media
Official title: Parental Research on Interventions for Social Media (Project PRISM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Underage Drinking
Lead sponsor: University of North Texas Health Science Center
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-04-03
Enrollment: 202
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria (Parents):

* have a child between the ages of 15-20 who currently lives with them
* believe that their child is active on at least one SNS
* live in Texas
* valid email address
* own a cell phone with text messaging capabilities and be ok with receiving messages
* provide valid contact information for their teen
* and willing to complete a 6 month long pilot study

Inclusion Criteria (Teens):

* being between the ages of 15-20
* be active on at least one SNS
* live in Texas
* valid email address
* own a cell phone with text messaging capabilities and be ok with receiving messages
* and willing to complete a 6 month long pilot study

Exclusion Criteria:

* not meeting inclusion criteria
* unwillingness to participate
* failure to provide consent (e.g., declining participation in the study)
* providing inconsistent responses (e.g., age) identified by the survey and introductory study telephone call
* and having already participated in the study as identified by overlap or consistency in computer IP addresses, contact information, and demographics.

Primary outcomes:
measure: Acceptability (Parent)- Program Usefulness
timeFrame: Data will be collected at 1 month follow-up
measure: Acceptability (Parent)- Relationship
timeFrame: Data will be collected at 1 month follow-up
measure: Acceptability (Teen)- Relationship
timeFrame: Data will be collected at 1 month follow-up
measure: Acceptability (Teen)- Percentage Who Would Recommend the Program
timeFrame: Data will be collected at 1 month follow-up
measure: Acceptability (Parent)- Percentage Who Would Recommend the Program
timeFrame: Data will be collected at 1 month follow-up
Secondary outcomes:
measure: Drinking Days in Past Month (Teen)
timeFrame: Data will be collected at 1 month follow-up
measure: Drinking Days in Past Month (Teen)
timeFrame: Data will be collected at 6 month follow-up
measure: Communication About Alcohol and Social Media (Parent)
timeFrame: Data will be collected at 1 month follow-up
measure: Communication About Alcohol and Social Media (Parent)
timeFrame: Data will be collected at 6 month follow-up
measure: Communication About Alcohol and Social Media (Teen)
timeFrame: Data will be collected at 1 month follow-up
measure: Communication About Alcohol and Social Media (Teen)
timeFrame: Data will be collected at 6 month follow-up
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center
state: Texas
Study officials:
affiliation: University of North Texas Health Science Center
name: Dana M Litt, PhD
role: PRINCIPAL_INVESTIGATOR
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