- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study will examine the feasibility and acceptability of using an implementation strategy, performance feedback and facilitated practice, to train teen helpers in Motivational Interviewing (MI) within a helpline setting. MI will be delivered with the goal of increasing help-seeking in real life among helpline users. The study will take place within Teen Talk App, a text-based teen-to-teen helpline. The study will use human centered design principles to engage stakeholders in developing and refining the MI training and implementation strategy (performance feedback and facilitated practice).
First, teen peer helpers and their supervisors/leaders will be engaged to adapt and co-design an MI training that will be responsive to the helpline context. This will include adapting MI to brief, text-based exchanges. As part of the Discover stage in human-centered design, focus groups will be conducted with Teen Talk App teen helpers (3 focus groups, n=4 each) and supervisors/ leaders (2 focus groups, n=5 each), along with individual interviews with users (n=12), to explore how to adapt MI for use within an online, text-based teen peer delivered helpline context. Focus groups and interviews will explore stakeholders' perceptions of the role of Teen Talk App in supporting IRL help-seeking and solicit feedback on how MI strategies can be adapted for use within Teen Talk App. Results from the preliminary work conducted by the current research team will be presented to describe current MI skill use among Teen Talk App helpers. Teen helpers will be asked to provide feedback on how MI strategies can be adapted for the diverse brief, text-based exchanges they encounter on the application. Supervisors/ leaders will be asked to provide feedback on how MI may fit within their existing protocols and trainings. Based on the feedback provided in the Discover stage, a rapid prototype MI workshop will be designed for training Teen Talk App peer helpers. An iterative process of presenting and refining the workshop will occur based on stakeholder input across three workshops (n=4 each). First, the workshop will be presented to teen helper stakeholders. Workshops will be co-facilitated by the PI, a Clinical Psychology PhD student, and a Teen Talk App supervisor/ leader. Each workshop will be followed by individual cognitive interviews with the stakeholder teen helpers. Participants from the interviews will be invited to a follow up focus group where results from the interviews will be presented to them for further feedback. Supervisors/ leaders will be interviewed to process the workshop and their impressions of helpers' reactions. Findings from these focus groups will be integrated to refine the workshop prototype. While three iterations are proposed, focus groups participants will determine whether further iterations are needed.
The study will then engage teen peer helpers and their supervisors/ leaders to co-design a performance feedback interface, using MI adherence metrics provided by an Artificial Intelligence derived tool (Lyssn) and the structure of facilitated practice sessions. As part of the Discover stage, teen peer helpers (3 focus groups, n=4 each) and supervisors/ leaders (2 focus groups, n=5 each) will be invited to two rounds of focus groups to discuss their perspectives about the acceptability of AI-derived PF or FP. At the beginning of each focus group, they will receive a general overview of PF or FP. Teen helpers will be asked to provide feedback on how to promote motivation and receptivity of the training feedback. Supervisors/leaders will be asked similar questions, along with suggestions for how to integrate the implementation strategy into existing workflows. Users will not be engaged in this study aim given the focus on developing a provider-facing implementation strategy. Based on the feedback provided in the Discover stage, two rapid prototypes (performance feedback and facilitated practice; PF and FP) will be designed for training Teen Talk App peer helpers. Separate iterative processes of presenting and refining the prototypes will occur based on helper (n=12) and supervisor/ leader (n=10) input across at least three cycles for each PF and FP. At the end of an iteration cycle, focus groups participants will determine whether further iterations are needed. The PF prototype will be developed by the research team to integrate MI adherence metrics provided by Lyssn, with the goal of displaying metrics in an age-appropriate manner that promotes motivation, openness, and encourages teen helpers to continue towards adherent delivery of MI. An iteration cycle will begin by individually presenting stakeholders with a prototype report as part of a cognitive interview. They will be provided a general overview of PF and MI. The prototype will provide example metrics on individual adherence to MI strategies, suggesting areas for improvement. Participants will be instructed to pretend the feedback was based on their individual use of MI.They will then be asked provide their perspectives about the tool's effectiveness, acceptability, and appeal, and suggestions for improvement (e.g., in content wording and display). Participants from the interviews will be invited to a focus group where results from the interviews will be presented to them for further feedback.
Findings from these focus groups will be integrated to refine the PF prototype as part of the next iteration cycle.
To refine the FP strategy, new and former participants will be invited to one of three facilitation groups with the goal of practicing MI skills (initial prototype). FP groups will be led by the PI, a trained Clinical Psychology PhD student, and a Teen Talk App supervisor/ leader. Each group will have two breakout rooms that will each provide targeted practice of specific MI strategies. Participants will be asked to use the mockup PF tool to determine the breakout room in which they should participate. To enhance rapid feasibility of this iterative prototyping stage, only two MI strategies will be selected for prototyping at this stage. Practice will involve the use of role plays, behavioral shaping, and positive reinforcement strategies delivered by an MI trainer. Helper participants will be asked to provide feedback on this process through individual cognitive interviews and focus groups, following the same process described above for the iteration of PF strategies. Cofacilitator Teen Talk App supervisors/ leaders will be interviewed about their impressions of the FP groups and helpers' reactions.
Finally, the study will test the feasibility of integrating the adapted MI into a helpline with the support of the implementation strategy (PF-FP). All Teen Talk App helpers will have the opportunity to be trained in MI. Initial MI training will occur over two meetings, comprised of a workshop and online practice session. To maximize training reach, three cohorts will be trained across consecutive months. To align with routine workflows, MI training will be offered during regularly scheduled monthly Teen Talk App continuing education (CE) online meetings. Following completion of the MI workshop and online practice, teen helpers who enroll in the research study (N=50) will be randomized to receive either online training as usual (i.e., monthly CEs) or online enhanced training (i.e., monthly PF-FP) for 6 months. Participants in the enhanced training condition will receive monthly PF reports that include their Lyssn metrics on MI skill use based on their Teen Talk exchanges. FP sessions will offer targeted practice exercises to promote specific MI skills indicated as low on each helpers' PF report. Participants will be placed in a breakout room that corresponds to the targeted MI skill areas indicated by their PF reports. MI training and enhanced training will be delivered by the PI and a PhD student who has obtained MI certification. TAU will be delivered by Teen Talk App staff. Teen helpers will participate in study assessments at baseline prior to the MI workshop, immediately after the MI training, and after 4 and 7 months of ongoing training (TAU or enhanced with PF-FP). They will be compensated $25 per survey and $50 for completing a qualitative interview at the end of the trial. During the trial, supervisors/ leaders (n=5), and helpers (n=5) will be invited to participate in monthly periodic reflections to support ongoing PF-FP iteration. Participants will be compensated $50 for each reflection. To measure the effect of the implementation strategy on clinical outcomes, Teen Talk users will also be recruited into the study. Users who are acutely suicidal (designated a "high risk" flag based on Teen Talk App algorithm) will not be recruited to avoid interrupting Teen Talk App's emergency workflow. Users who are actively engaged with Teen Talk App helpers (i.e., a minimum of 6 back-and-forth text exchanges, established in our preliminary study) will be invited to participate in the current study. During the study enrollment period, all users who meet study criteria will receive a pop-up notification on the Teen Talk App application inviting them to participate in a brief, de-identified survey where no sensitive information will be collected. User participants (N=100) will be asked to complete very brief follow-up surveys 1 week, 4 weeks, 3 months, and 6 months after their baseline measures (see Table 5). A small subset of user participants (n=15) will complete a qualitative interview to examine acceptability of MI strategies in Teen Talk and the intended objective of promoting IRL help-seeking. Users will receive $10 per survey (i.e., 5-10 minutes) and $50 for the interview.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
California
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San Diego, California, Forenede Stater, 92182-8000
- Rekruttering
- San Diego State University
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Kontakt:
- Sylvanna M. Vargas, MPH, PhD
- Telefonnummer: 3057614632
- E-mail: svargas3@sdsu.edu
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
All current teen helpers (N=255) will be invited to participate in the research study prior to the MI workshops. Helper participants who provide assent and documented parental consent will be asked to complete study measures prior to the first MI training session (see Human Subjects Study Timeline, Aim 3). Helpers who wish to participate in the research study must have attended and completed the MI training activities. Additionally, helpers must have the ability to participate in online (i.e., access to a computer, tablet, or smart phone with a videocamera and microphone) research activities. Given that Teen Talk App helpers volunteer remotely on the Teen Talk App, they will likely all have access to electronics needed to participate in online activities. Teen Line staff will similarly have access to this technology. The age range of current Teen Talk peer helpers is 14-19 years.
To be eligible for the study, users must have at least 20 back-and-forth text exchanges with a Teen Talk App helper. The inclusion threshold for users is based on preliminary data indicating feasibility of reliable detection of MI skill use using adapted MITI codes. Given that the study clinical outcomes relate to help-seeking IRL via implementing MI's collaborative communication style, only users who display active communication and engagement with helpers (based on the minimum threshold described above) on the Teen Talk App/ Teen Line will be recruited. Additionally, users must have the ability to participate in an online (i.e., access to a computer, tablet, or smart phone, potentially with a videocamera and microphone) survey and potentially, interview. Given that users access the application via a similar technology, it is likely most qualifying users will meet this criterion. Teen Line users will likely have access as well. Between January- May 2023, Teen Talk received an average of 319 posts/month, with an average length of 18 posts per exchange. Therefore, it is conservatively estimated that a <10% response rate will be needed to recruit 100 eligible users over 4 months. Users between the ages 13-19 years are eligible for inclusion in this study. Users must be current US residents.
Exclusion Criteria:
- Helpers who indicate they plan to end their Teen Talk App or Teen Line activities within the next 8 months will not be invited to participate in the research study, due to the study length. Helper study participants, regardless of condition, will attend a monthly training session (TAU: monthly CE offered by Teen Talk App; experimental condition: PF-FP sessions). The age range of current Teen Talk peer helpers is 14-19 years.
Users expressing current acute suicide risk ("high risk" flag based on Teen Talk App algorithm, identified by staff at Teen Line) will not be recruited to avoid interrupting the helplines' emergency workflows. Teen Talk App has an internal algorithm that automatically detects key words associated with suicidal risk. Posts with these keywords are automatically tagged as "high-risk". While all initial and off-hours posts on Teen Talk App receive an automatic message directing users to emergency services if they are in acute distress or suicidal, posts that are tagged as high-risk are given priority during Teen Talk App users' live hours. Teen Talk App has an internal process that involves helpers (with live supervisor support) assessing, responding to, and intervening with users who are experiencing acute suicidal risk. This includes directing users to or deploying emergency services. Given that the current study is focused on the feasibility of implementing MI within an existing service sector, it is critical to not disrupt Teen Talk App's workflow and emergency procedures. More importantly, users in acute crises require priority services and support, including possibly emergency transport. Thus, the current study will exclude users associated with "high-risk" flags to avoid interfering with Teen Talk App's emergency protocol and workflow, and to support users in prioritizing accessing needed support including potentially emergency services. Users between the ages 13-19 years are eligible for inclusion in this study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
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Ingen indgriben: 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).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
General Help Seeking Questionnaire
Tidsramme: 11 months (consent to post 6-month follow up)
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Measure of help seeking behavior
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11 months (consent to post 6-month follow up)
|
|
Patient Health Questionnaire-8
Tidsramme: 11 months (consent to post 6-month follow up)
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Measure helpline user distress
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11 months (consent to post 6-month follow up)
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- IRB-24-0310
- K23MH137387 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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