- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07664644
Hybrid Type 1 Trial of a Parent-Based Intervention Addressing Social Media and Adolescent Alcohol Use
18. juni 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
900
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Dana Litt, PhD
- Telefonnummer: 3032044109
- E-mail: dana.litt@uta.edu
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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.
|
|
Aktiv komparator: 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.
|
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.
|
|
Aktiv komparator: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Drinking Refusal Self-Efficacy
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Alcohol Initiation
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juli 2027
Primær færdiggørelse (Anslået)
1. august 2030
Studieafslutning (Anslået)
1. august 2030
Datoer for studieregistrering
Først indsendt
15. juni 2026
Først indsendt, der opfyldte QC-kriterier
18. juni 2026
Først opslået (Faktiske)
24. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-619
Plan for individuelle deltagerdata (IPD)
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