- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07639736
Teen Helpline Motivational Interviewing Study (MI)
Using Performance Feedback and Facilitation to Integrate Motivational Interviewing in Teen Helpline Services
The proposed study will establish a foundation for research within peer-delivered helplines for teens. It aims to evaluate the impact of a Motivational Interviewing training at peer-to-peer helpline. The study will leverage emerging technologies to surmount the challenges of providing tailored training to a large and diverse mental health workforce at scale.
Aim 1: Adapt Motivational Interviewing (MI) strategies for use in a teen peer-delivered text-based digital helpline.
Aim 2: Co-design performance feedback (PF) and facilitated practice (FP) processes to support MI adherence among peer helpers.
Aim 3: Examine feasibility, acceptability, and initial outcomes in a pilot feasibility trial. Peer helpers (N=50) will be randomized to receive MI training or MI training + PF-FP.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This study will adapt and implement Motivational Interviewing (MI) within Teen Talk App, a text-based teen-to-teen helpline, with the goal of increasing real-world help-seeking among youth users. Using human-centered design methods, teen helpers, supervisors, and users will participate in focus groups, interviews, and iterative prototyping activities to adapt MI for brief text-based interactions and to refine an implementation strategy consisting of performance feedback and facilitated practice (PF-FP). Stakeholder input will be used to ensure the intervention and implementation strategy are acceptable, feasible, and fit within existing helpline workflows.
Following adaptation, a pilot feasibility trial will evaluate the implementation strategy among Teen Talk peer helpers. Helpers who enroll in the study (N=50) will be randomized to receive either training as usual or enhanced training consisting of monthly performance feedback and facilitated practice sessions over a 6-month period. Teen Talk users (N=100) will also be recruited to assess clinical outcomes, including help-seeking behaviors and mental health symptoms. The study will provide preliminary data on implementation outcomes, helper MI skill use, and user outcomes to inform a future fully powered effectiveness-implementation trial.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
California
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San Diego, California, Vereinigte Staaten, 92182-8000
- Rekrutierung
- San Diego State University
-
Kontakt:
- Sylvanna M. Vargas, MPH, PhD
- Telefonnummer: 3057614632
- E-Mail: svargas3@sdsu.edu
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria
Teen Helpers
- Current helpline peer helpers
- Aged 14-19 years.
- Provides assent and documented parental consent (when applicable).
- Completes study measures prior to the first Motivational Interviewing (MI) training session.
- Attends and completes assigned MI training activities.
- Has access to technology required for online participation (computer, tablet, or smartphone with internet access; videoconferencing capability if needed).
- Plans to continue helpline activities throughout the study period.
Teen Users
- Aged 13-19 years.
- Current U.S. resident.
- Has engaged in at least 20 back-and-forth text exchanges with a helpline volunteer.
- Demonstrates active communication and engagement on the helpline platform.
- Has access to technology required to complete online surveys and, if selected, interviews (computer, tablet, or smartphone with internet access).
Exclusion Criteria
Teen Helpers
- Plans to discontinue helpline activities within the next 8 months.
Teen Users
- Identified as currently experiencing acute suicide risk (i.e., assigned a "high-risk" flag by the helpline algorithm or identified as high risk by helpline staff).
- Requires immediate crisis intervention or emergency services that could be disrupted by participation in the research study.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Performance feedback and facilitated practice
Helpline volunteers randomized into this study arm will receive additional MI training through feedback and practice (they will receive standard helpline training and MI training).
|
All participants will receive Motivational Interviewing training through an educational workshop.
Participants in the intervention arm will receive performance feedback and facilitated practice (implementation strategy).
Those in the control arm will receive training as usual.
|
|
Kein Eingriff: Training as usual
Helpline volunteers randomized into this study arm will not receive additional MI training through feedback or practice (they will receive standard helpline training only).
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
General Help Seeking Questionnaire
Zeitfenster: 11 months (consent to post 6-month follow up)
|
Measure of help seeking behavior.
Minimum score = 10; Maximum score = 70.
Higher scores indicate greater intentions or willingness to seek help.
|
11 months (consent to post 6-month follow up)
|
|
Patient Health Questionnaire-8
Zeitfenster: 11 months (consent to post 6-month follow up)
|
Measure helpline user distress.
Minimum score = 0; Maximum score = 24.
Higher scores indicate greater depressive symptom severity.
|
11 months (consent to post 6-month follow up)
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- IRB-24-0310
- K23MH137387 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Quantitative Data. De-identified, clinical self-report questionnaires from the pilot trial (Aim 3) will be shared via the National Institute of Mental Health Data Archive (NDA).
Qualitative data will not be shared to protect participant confidentiality.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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