Adolescent Alcohol UseNCT07664644
Hybrid Type 1 Trial of a Parent-Based Intervention Addressing Social Media and Adolescent Alcohol Use
A study testing Combined Alcohol and Social Media PBI and PFI, Alcohol and Social Media PBI and Power of Parents in people with Adolescent Alcohol Use, run by The University of Texas at Arlington.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adolescent Alcohol Use
- What is being tested?
- Combined Alcohol and Social Media PBI and PFI, Alcohol and Social Media PBI and Power of Parents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- Jul 2027to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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, the study 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.
- Conditions
- Adolescent Alcohol Use
- Being tested
- Combined Alcohol and Social Media PBI and PFI, Alcohol and Social Media PBI, Power of Parents
- Medical subject headings
- Underage Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Alcohol and Social Media PBI and PFIBehavioural
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.
Alcohol and Social Media PBIBehavioural
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.
Power of ParentsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol and Social Media PBI and Adolescent Alcohol and Social Media PFI | Experimental | 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. Receives: Behavioral: Combined Alcohol and Social Media PBI and PFI |
| Alcohol and Social Media PBI | Active comparator | The alcohol and social media PBI will be based on pilot work 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. Receives: Behavioral: Alcohol and Social Media PBI |
| Alcohol PBI | Active comparator | Parents will be emailed a link to the Power of Parents Handbook, which is a 52- page static PBI handbook 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. Receives: Behavioral: Power of Parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinking Refusal Self-Efficacy
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.
Measured: Baseline, 1, 6, 12 month assessments
Alcohol-related social media communication
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.
Measured: Baseline, 1, 6, 12 month assessments
Alcohol Willingness
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.
Measured: Baseline, 1, 6, 12 month assessments
Secondary outcomes (1)
Alcohol Initiation
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).
Measured: Baseline, 1, 6, 12 month assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study startJul 2027 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Alcohol UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Arlington
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, UTHealth Houston, University of North Texas Health Science Center
- Responsible party
- Principal investigator, Dana Litt, The University of Texas at Arlington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664644
- Sponsor's protocol ID
- 2025-619
- Status last verified
- Oct 2026
- First submitted
- 15 Jun 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Type 1 Effectiveness Implementation Trial of a Parent-Based Intervention to Address Social Media Influences on Adolescent Alcohol Outcomes
- ClinicalTrials.gov ID
- NCT07664644
- Acronym / sponsor ID
- 2025-619
- Conditions
- Adolescent Alcohol Use
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- The University of Texas at ArlingtonUniversity, hospital or other
- Collaborators
- University of Washington, UTHealth Houston, University of North Texas Health Science Center
- Study start
- Jul 2027 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, the study 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alcohol and Social Media PBI and Adolescent Alcohol and Social Media PFI | Experimental | Behavioral: Combined Alcohol and Social Media PBI and PFIParents 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. |
| Alcohol and Social Media PBI | Active comparator | Behavioral: Alcohol and Social Media PBIThe alcohol and social media PBI will be based on pilot work 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. |
| Alcohol PBI | Active comparator | Behavioral: Power of ParentsParents will be emailed a link to the Power of Parents Handbook, which is a 52- page static PBI handbook 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Alcohol and Social Media PBI and PFIParents 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. | Behavioural | Alcohol and Social Media PBI and Adolescent Alcohol and Social Media PFI |
| Alcohol and Social Media PBIThe 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. | Behavioural | Alcohol and Social Media PBI |
| Power of ParentsParents 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. | Behavioural | Alcohol PBI |
Primary outcome
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.
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.
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.
1 secondary outcome
Alcohol Initiation
Time frame: Baseline, 1, 6, 12 month assessments
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Adolescent Alcohol Use
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems
Alcohol Use, Adolescent
Recruiting
ChangeGradients: Promoting Adolescent Health Behavior Change
Alcohol Drinking, Self Efficacy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Alcohol and Social Media PBI and PFI, Alcohol and Social Media PBI and Power of Parents in people with Adolescent Alcohol Use, run by The University of Texas at Arlington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dana Litt, PhD (3032044109, dana.litt@uta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinking Refusal Self-Efficacy (time frame: Baseline, 1, 6, 12 month assessments). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.