Hybrid Type 1 Trial of a Parent-Based Intervention Addressing Social Media and Adolescent Alcohol Use

June 18, 2026 updated by: Dana Litt, The University of Texas at Arlington

A Hybrid Type 1 Effectiveness Implementation Trial of a Parent-Based Intervention to Address Social Media Influences on Adolescent Alcohol Outcomes

The central goal of this application is to conduct a Hybrid Type 1 effectiveness-implementation randomized controlled trial to test the comparative effectiveness of an alcohol and social media parent-based intervention (PBI), compared to both a combined approach whereby parents receive the alcohol and social media PBI and adolescents receive an alcohol and social media personalized feedback intervention (PFI) and to an efficacious alcohol PBI handbook. Additionally, we will determine key implementation determinants that are crucial to optimizing effectiveness when delivered in community settings. The proposed study will address each of these goals in turn by enrolling parent and adolescent (age 12-17) dyads and collaborating with key community members.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
900

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Parents/legal guardian inclusion criteria:

  • Have a child between the ages of 12-17 who lives with them
  • Believe that their child is active on at least one social media platform
  • Live in Texas
  • Provide a valid email and phone number
  • Own a cell phone with text messaging capabilities and be okay with receiving messages
  • Provide valid contact information for their adolescent
  • Willing to participate in respective phase.

Adolescent inclusion criteria:

  • Have an eligible parent with whom they live
  • Age 12-17
  • Live in Texas
  • Active at least weekly on at least one social media platform
  • Provide a valid phone number and email address
  • Own a cell phone with text messaging capabilities and be okay with receiving text messages,
  • Willing to participate in respective phase

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Alcohol and Social Media PBI and Adolescent Alcohol and Social Media PFI
Parents will receive the alcohol and social media PBI and adolescents will receive a brief alcohol and social media PFI based on our previous work. The PFI will use data from the adolescent baseline survey to create personalized alcohol and social media intervention feedback including normative comparisons to peers and summaries of risk behaviors. Adolescents will be encouraged to complete the PFI in one sitting but can revisit as many times as they like.
Behavioral: Combined Alcohol and Social Media PBI and PFI
Parents will receive the alcohol and social media PBI and adolescents will receive a brief alcohol and social media PFI based on our previous work (PI: Litt, R21AA024163; Litt et al., 2023; Lewis et al., 2019; Larimer et al., 2021, 2023). The PFI will use data from the adolescent baseline survey to create personalized alcohol and social media intervention feedback including normative comparisons to peers and summaries of risk behaviors. Adolescents will be encouraged to complete the PFI in one sitting but can revisit as many times as they like.
Active Comparator: Alcohol and Social Media PBI
The alcohol and social media PBI will be based on our pilot work (R34AA026332) and updated/tailored based on Aim 1 FGs. The PBI will be delivered via a web-based format such that parents will be sent an email and a text message containing a URL to the alcohol and social media PBI website along with guidelines for working through the modules (see below for overview of modules). The website will allow parents to navigate through the modules at their own pace/sequence. Each module will have interactive elements including animations, infographics, and videos to highlight key content. Parents will be sent one text message per week encouraging them to use the website.
Behavioral: Alcohol and Social Media PBI
The alcohol and social media PBI will be based on our pilot work (R34AA026332) and updated/tailored based on Aim 1 FGs. The PBI will be delivered via a web-based format such that parents will be sent an email and a text message containing a URL to the alcohol and social media PBI website along with guidelines for working through the modules (see below for overview of modules). The website will allow parents to navigate through the modules at their own pace/sequence. Each module will have interactive elements including animations, infographics, and videos to highlight key content. Parents will be sent one text message per week encouraging them to use the website.
Active Comparator: Alcohol PBI
Parents will be emailed a link to the Power of Parents Handbook, which is a 52- page static PBI handbook (Turrisi et al., 2001, 2009, 2013) housed on the MADD website offered in English and Spanish. The alcohol PBI instructs parents to use an empathic communication style while providing information about alcohol use.
Behavioral: Power of Parents
Parents will be emailed a link to the Power of Parents Handbook, which is a 52- page static PBI handbook (Turrisi et al., 2001, 2009, 2013) housed on the MADD website offered in English and Spanish. The alcohol PBI instructs parents to use an empathic communication style while providing information about alcohol use.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Drinking Refusal Self-Efficacy
Time Frame: Baseline, 1, 6, 12 month assessments
The Drinking Refusal Self-Efficacy Questionnaire will assess beliefs in one's ability to resist alcohol (Young et al., 2007; α = .96). Responses range from 1 (I am very sure I would drink) to 6 (I am sure I would not drink) with higher scores indicating greater drinking refusal self-efficacy.
Baseline, 1, 6, 12 month assessments
Alcohol-related social media communication
Time Frame: Baseline, 1, 6, 12 month assessments
Alcohol-related social media communication between parents and adolescents will be assessed using the "Alcohol-related Social Media Communication Scale, which is adapted from Turrisi et al., 2000; α = .96). Participants will indicate whether they spoke about a range of topics (yes/no) in the past month with higher scores indicating greater alcohol-related social media communication.
Baseline, 1, 6, 12 month assessments
Alcohol Willingness
Time Frame: Baseline, 1, 6, 12 month assessments
The willingness measure will assess adolescent willingness to drink in certain scenarios (α = .85; Gerrard et al., 2008) using a response rage of 0 (not at all willing) to 4 (extremely willing). Higher scores indicate greater willingness to use alcohol.
Baseline, 1, 6, 12 month assessments

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Alcohol Initiation
Time Frame: Baseline, 1, 6, 12 month assessments
Alcohol initiation for those who abstain at baseline will be calculated as time-to-event from baseline date to participants' reported date of first use using timeline follow-back methods (Sobell & Sobell, 1992) and reporting the approximate date they first used alcohol, an approach used in our current work (R01AA025611).
Baseline, 1, 6, 12 month assessments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas at Arlington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Washington
University of North Texas Health Science Center
UTHealth Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-619

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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