A Parent-Based Intervention for Reducing High-risk Social Media Cognitions, Alcohol Use, and Negative Consequences Among Adolescents: Protocol for a Randomized Controlled Pilot Study

Background The prevalence of adolescent alcohol use continues to be a public health concern. 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. Extensive research in this area has resulted in parent-based intervention (PBI) efforts to prevent or reduce adolescent alcohol use. However, one major limitation of PBIs is that they do not currently consider the large role that social media plays in adolescents’ lives and in relation to their alcohol use. We will add to the literature by developing and refining a web-based PBI designed to reduce both high-risk social media cognitions and alcohol use among adolescents. Objective The central goal of the proposed study is to develop, refine, and pilot a web-based PBI to reduce both high-risk social media cognitions and alcohol use among adolescents. Methods A total of 100 parent-teen dyads will be randomly assigned to one of the following 2 conditions: intervention or control. Parents in the intervention group will be given access to the web-based PBI and suggestions for working through the PBI modules with their teens. The parent-teen dyads will fill out 3 questionnaires: a baseline questionnaire, 1-month questionnaire, and 6-month questionnaire. Results Recruitment and enrollment will begin in August 2022. Upon completion of the intervention trial, we will examine the feasibility, acceptability, and preliminary effect sizes of the newly developed web-based PBI. Conclusions This study has the potential to open doors for future studies examining the clinical implications of an efficacious web-based PBI to reduce alcohol use and high-risk cognitions about alcohol displays on social media. Trial Registration ClinicalTrials.gov NCT04333966; https://clinicaltrials.gov/ct2/show/NCT04333966 International Registered Report Identifier (IRRID) PRR1-10.2196/38543

AA-2 LITT, D Environment: 2 Overall Impact: This proposal seeks to build on the success of a parent-based intervention for adolescent alcohol use prevention by making it web-based and interactive as well as adding a component to address the problematic influence of alcohol depictions/posting on social network sites. There are a number of factors that contribute to the overall impact of the proposed project including: the potential of developing a prevention tool that would be likely to have a positive effect given previous research, the likely appeal to parents, the current lack of interventions or parent training to address SNS influence, and the readily disenable nature of a web-based intervention. The scientific premise for the study is strong. The design of the project and the research team positively affected the overall impact, although several minor weaknesses are noted to the approach.

Significance:
Strengths  A strong findings-based argument is made for the importance of parents as well as social network site (SNS) use in alcohol outcomes for adolescents, including newer longitudinal research findings providing more of a basis on which to infer causal associations -suggesting that both are important targets for prevention efforts.
 A strong argument is made that parents are in need of training on how to influence drinking and SNS use in effective ways for prevention.
 The interactive web-based format of the PBI with SNS intervention has the potential to be more efficacious than the currently available PBI.
 The focus on SNS has a high potential to appeal to parents given the important role of SNS in youth's lives and lack of general knowledge regarding how to parent with respect to technology.
Weaknesses  None noted.

Investigator(s):
Strengths  The research team has a record of grant funded research and publications in the areas under investigation, including SNS and internet-based interventions. The expertise of the research team in these areas is established. Each team member is responsible for aspects of the project that are particularly within their area of experience and expertise.
 The team has demonstrated the ability to recruit, retain, coordinate similar studies, and analyze similar data.
 The research team is productive and has successfully worked together in the past.

Weaknesses
 While the research team has considerable experience with the methodologies outlined, both the PI and Co-I are recent transplants to the university where the study will be conducted and to that area of the country. Dallas/Fort Worth has a considerably different demographic than Seattle, which may affect recruitment, focus groups, or the intervention in ways that may not be anticipated. Given that 34% of the sample is anticipated to be Latino there may be cultural differences in parenting practices as well as attitudes toward alcohol that need to be considered. Seeking local consultation or expertise would be worthwhile.

Innovation:
Strengths  Creation of an interactive, web-based intervention with text prompts for PBI is a significant innovation over current handbook-based interventions. This has a higher potential for parent uptake and use than traditional methods of delivery (static, written intervention).
 Including SNS use in an efficacious PBI is a significant innovation that is likely to enhance parental interest and the appeal of the intervention as well as to enhance the effects of PBI.

Weaknesses
 Making static content interactive and web-based is not necessarily paradigm changing.

Approach:
Strengths  A major strength is that the recruitment strategy is broad to reach parents who do and do not currently use SNS.
 Including youths age 18-20 in addition to 15-17-year olds is a strength given continued parental influence for this later age group, as well as the particular need for prevention in this high-risk group for alcohol use disorders.
 The use of focus group feedback from both parents and adolescents from different age ranges to refine the intervention is a major strength. The number of focus groups and large sample sizes are a significant strength.
 The parent and adolescent outcomes measured and longitudinal design, including a six-month follow-up period are a major strength.
 A major strength is that each phase of the project is well designed, including a TAU control that appears to be a good comparison group. Below weaknesses are note; however, each is relatively minor or easily addressed.

Weaknesses
 Although the AUDIT has been used with adolescents, it is a blunt tool for this population. The AUDIT as a measure of alcohol consequences in a general adolescent sample would seem to have quite poor sensitivity (floor effects) given the focus of many of the items on truly problematic drinking. A previous reviewer noted issues with the YAACQ as a measure designed for an older population, the AUDIT is likewise designed for an older sample and to screen for those with misuse in need of intervention. Therefore, it does not seem appropriate for the purposes of a prevention-based intervention and this study. However, its use for assessing risk and as part of the human subject's protections seems quite appropriate.
 The hypothesis of having differential recruitment, enrollment, and attrition in the intervention vs.
TAU is problematic, as this would indicate systematic bias thereby negating the ability to attribute change to the intervention and the benefit of random assignment.  A minor weakness was that the rationale for the eligibility criteria (as opposed to 13 or 14) was not provided.
 A minor weakness is that the focus group length of 90 minutes seems quite inadequate to cover all of the content planned and elicit feedback. These sessions would need to be considerably longer or use different focus groups to preview different samplings of the content. 1 R34 AA026332-01A1 5 AA-2 LITT, D  Providing $10 to the PBI group to encourage parents to take their child out to discuss issues seems like it would lower the external validity of the results of the pilot given that this would be an unlikely aspect of the intervention when it is disseminated, as well as raising issues of treating the conditions differently (internal validity).  There appears that there may be some additional ways in which the intervention groups are treated that may result in differential social desirability, expectancies, and demand characteristics among groups. For example, a letter sent to the PBS parents regarding the goals of the research, but apparently not to the TAU group.  Ten covariates are listed for inclusion in the GLMM models, this is excessive. I assume that these will be included as appropriate by dependent variable, but this was not stated. It may be worthwhile to examine for potential ethnic differences for inclusion as a covariate or moderator.

Strengths
 The PIs facilities and resources are well suited to successfully carrying out the proposed study.
 The reputation of The University of North Texas Health Science Center in relation to substance abuse research is not widely known; however, both the PI and the Co-I are seasoned investigators and are at this same institution. This suggests the opportunity for team-based problem solving and collaboration to overcome any potential challenges associated with the new environment.

Weaknesses
 While the facilities section is long, much of what is included is not directly relevant to the current study and factors that may affect the success of the current study are not elaborated on (e.g., dedicated space).

Study Timeline:
Strengths  Sufficient time is dedicated to each phase of the project.

Weaknesses
 Timeline could include more information to justify the time length devoted to phases of the study.

Protections for Human Subjects:
Acceptable Risks and/or Adequate Protections  Consent from both parents/guardians and children (minor and adult) appear adequate.
Protection of data and identities appears adequate.

Data and Safety Monitoring Plan (Applicable for Clinical Trials Only):
Acceptable o Protections are in place for participants with dangerous levels of alcohol consumption.
Adequate plans are in place to protect participant identities and personal information.  Sex/gender, race/ethnicity, and age inclusionary criteria are represented and justified. The study is restricted to adolescents and very young adults age 15-20 and their parents or guardians. This is justified given the parent-based intervention being studied.

Resource Sharing Plans:
 Acceptable  Other than personal no budget justification or details are provided thus it is difficult to judge whether the budget should be recommended without modifications.

Overall Impact:
This is a revision of an earlier proposal to modify an existing parent-based intervention approach. It seeks to provide parents with information about current teen issues with online social media access, social media use, and alcohol presence on social media. Its goal is to assist parents to more effectively engage in parental mediation of a teen social environment that is deeply saturated with social media sites. Most teens report going online daily, and much of this time is spent on social network sites where one quarter of adolescent profiles include alcohol-related content. Parents often have limited knowledge regarding their children's social media profiles or the types of online experiences they are having. This proposal is for an intervention to bridge this gap in parent knowledge. The intervention seeks to assist parents in a role as socialization agents to counter negative social media influence on drinking and focuses on risky alcohol cognitions in youth. The revision is now clear on ways social media influences are potentially stronger than other areas of media influence in adolescent drinking through their interactive nature and through a diminished separation of online and offline lives, as well as ways in which parent mediation of social media needs to change in order to be effective. The proposal addresses the issue of findings of mixed effects of the existing parent-based intervention and introduces a new component to parent-based intervention that may heighten its impact. The investigator team and environment are strong, and the focus on social media for a parent-based 1 R34 AA026332-01A1 7 AA-2 LITT, D intervention is innovative. In the revised proposal, instead of consisting entirely of parent readings in paper-based manuals, the parent educational materials are now web based and interactive. However, opportunities to provide parents experiential exposure to the types of immersive experiences of influence their own children are exposed to through alcohol related social media content does not yet seem maximally realized through what is described in the approach. Specific recruitment efforts are now detailed that will be used to facilitate diverse recruitment. The revision now proposes to use as a main alcohol outcome measure a measure that has been validated with adolescents, and outcomes are now extended out to 6 months posttreatment. The GLM model is now precisely described and possible covariates to be explored are now clearly and extensively delineated.

Significance:
Strengths  Parental influences to discourage drinking are strongly associated with reductions in adolescent drinking.
 Teens report being online daily with a majority of time on social network sites; data indicates up to 1⁄4 of adolescent social network site profiles include alcohol-related content; at the same time parents often have limited knowledge regarding this content and youth internet experience in general.
 Parent based intervention approaches have not kept up with social media and the role of social media in adolescent experience and socialization to alcohol.  There is a need for intervention to bridge this gap by providing parents with information about teen social media use and social media alcohol exposures to assist parental mediation as socialization agent to prevent teen alcohol misuse.
 The revision presents important research findings that, "There is a robust relationship between exposure to SNS alcohol content and alcohol consumption six months later, which persists even after close friends' drinking was accounted for (Boyle et al., 2016)" that addresses a question about the significance of this study: does exposure to alcohol displays through social media sites lead to risky alcohol cognitions in ways that are additive to the impacts of more direct life experience in family and peer settings? Further, the authors note: "adolescents use SNS to reconstruct negative and risky drinking practices into positive outcomes (Hebden et al., 2015;Lyons et al., 2015) in order to avoid acknowledging any implications of or reference to negative consequences associated with drinking (Niland et al., 2014)" suggesting social media sites may lead to risky alcohol cognitions in ways that are potentially different and more powerful.
 The investigators are now much clearer in their theory and rationale regarding the significance of social media sites in their influence on youth. The revision now describes literature on how traditional media channels cultivated passive observers who were not able to influence content, while social media sites allow users to participate in how content is created and shared. The revision also notes how parents often find it difficult to relate to how for their digitally savvy children online lives are an extension of their offline lives, and importantly, given social media sites' interactivity, immersive virtual environments, and mediated communication, general parental mediation strategies for more traditional forms of media may not be effective for this new medium.
 Given this universal intervention can be offered with ease of dissemination and at low-cost, its modest intervention effects, on a population level, can be significant.
 Previous research on parent-based intervention has produced inconsistent findings and modest effect sizes; however, this approach may enhance its effects in moving from static formats of parent handbooks to web-based, more interactive formats.

Investigator(s):
Strengths  Dr. Litt has strong history of work with parent-based intervention, clinical trials research, and recently completed research on impact of alcohol displays on social networking sites on adolescent alcohol use.
 Dr. Lewis has a long history of success conducting theory-driven research focused on the role of social influence on the etiology and prevention of drinking along with work on 10 NIAAA-and NIDA-funded longitudinal research projects.
 As consultants, Dr. Turrisi has background to assist in development and refinement of the parent intervention while Dr. Moreno can provide focus group questions, refining of intervention materials, measurement development, and design.

Weaknesses
 None noted

Innovation:
Strengths  The intervention would train and assist parents to address social network site social influence.
 The intervention inserts education on social network sites and their potential influence on risky alcohol cognitions into an established evidence-based parent-based intervention approach.
 A strength in this revised proposal is, in keeping with the project focus upon digital media's impacts upon youth and a migration of sources of social influence on youth to social media, the proposed intervention materials are also moving from paper to web-based, interactive, and accompanied by text message prompts.
Weaknesses  There remains an unrealized opportunity for the web-based interactive training materials to actually provide experiential examples of the interactivity, immersive virtual environments, and mediated communication that would provide adults with the kinds of experiences their children are currently encountering; this would enhance parent understanding of these digital sources of influence and the vanishing distinction between online and offline lives.

Approach:
Strengths  Excellent focus group and cognitive interviewing strategies in intervention development efforts.
 An addition to the revised design is to now measure parental education/literacy as a covariate.
 A 6 month follow up assessment provides additional evidence especially with regards to the sustainability of impact over time.
 The revised proposal now emphasizes feasibility and acceptability of the intervention as critical research questions for the pilot implementation study, and precisely operationalizes each.
1 R34 AA026332-01A1 9 AA-2 LITT, D  The proposed analysis to explore treatment differences and determine preliminary effect sizes is now thoroughly documented. The GLMM is now presented in the revision through conventional mixed model conventional notation , and in addition, covariates to be considered are presented, and include age, gender, parent-teen relationship satisfaction, adult attitudes and teen perceptions of their parents' attitudes toward teen alcohol use and alcohol displays on SNS, parental monitoring, parental education, baseline levels of teen drinking and consequences, SNS use, and baseline levels of communication about alcohol use and SNS will be used as covariates.
 Retention efforts are significant and are now extensively described in the revision, and include efforts directed towards enhanced diversity in the sample.

Weaknesses
 Elements related to clinical trials support appropriate for the trial proposed that facilitate investigator ability to conduct the trial and meet its regulatory and reporting requirements are not specified.

Study Timeline:
Strengths  The timeline describes time periods for basic elements of the study including start-up activities.

Weaknesses
 The timeline does not take into account anticipated rate of enrollment and delineate the planned follow-up assessments.
 The timeline does not describe how the project incorporates efficiencies and utilizes existing resources at the home institutions. Acceptable o The data safety management plan is thorough and well-conceived. A plan is now in place for identifying and referring individuals who report significantly worsening alcohol use trajectories as well as consumption of potentially lethal doses of alcohol (BAC's above .35) and potential for alcohol use disorder as measured on the AUDIT. Once identified, these individuals will be contacted by the PI within 48 hours to explain their risk and to provide referral. The investigators note in their response ot reviews "all teens" will receive information about alcohol use regardless of their personal risk to address confidentiality concerns. The investigators need to clarify what is meant by "teens" and if this means under 18 or all youth under 21, for which drinking is illegal. The investigators clarify that parents will not be notified specifically about their children's level of risk but will receive general information instead. The investigators in this revision have clarified that while ultimate outcomes from the intervention impact youth and young adults, including children from age 15-17, as reported through self-report assessments, the intervention procedures are entirely focused on parents. Therefore, though the study involves children, which are a vulnerable population in the NIH definition, the intervention activities occur with their parents, and is therefore seems best understood as a Phase II clinical trial that does not involve participants from a vulnerable population, and a DSMB is not required.

Inclusion of Women, Minorities and Children:
 Sex/Gender: Distribution justified scientifically