- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07664644
Hybrid Type 1 Trial of a Parent-Based Intervention Addressing Social Media and Adolescent Alcohol Use
18. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Studientyp
Interventionell
Einschreibung (Geschätzt)
900
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Dana Litt, PhD
- Telefonnummer: 3032044109
- E-Mail: dana.litt@uta.edu
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
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.
|
|
Aktiver 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.
|
|
Aktiver 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Drinking Refusal Self-Efficacy
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Alcohol Initiation
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Juli 2027
Primärer Abschluss (Geschätzt)
1. August 2030
Studienabschluss (Geschätzt)
1. August 2030
Studienanmeldedaten
Zuerst eingereicht
15. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. Juni 2026
Zuerst gepostet (Tatsächlich)
24. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
24. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
18. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2025-619
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Nein
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