- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92182-8000
- Recruiting
- San Diego State University
-
Contact:
- Sylvanna M. Vargas, MPH, PhD
- Phone Number: 3057614632
- Email: svargas3@sdsu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
No Intervention: 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
General Help Seeking Questionnaire
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB-24-0310
- K23MH137387 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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