[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07639736":3,"trial-entities:NCT07639736":92,"trial-summary:NCT07639736":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":39,"secondary_outcomes":47,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":69,"locations":73,"central_contacts":88,"overall_officials":89,"references":90,"see_also_links":91},"NCT07639736","IRB-24-0310","Teen Helpline Motivational Interviewing Study","Using Performance Feedback and Facilitation to Integrate Motivational Interviewing in Teen Helpline Services","RECRUITING","2029-10-31","2026-06","2026-06-25","2025-08-28","San Diego State University","OTHER",true,"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.\n\nAim 1: Adapt Motivational Interviewing (MI) strategies for use in a teen peer-delivered text-based digital helpline.\n\nAim 2: Co-design performance feedback (PF) and facilitated practice (FP) processes to support MI adherence among peer helpers.\n\nAim 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.","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.\n\nFollowing 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.",[19,20],"Implementation Research","Help Seeking",[22,23,24,25],"Adolescent mental health","Implementation Science","Motivational Interviewing","Mental health helplines","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[29],"NA",{"count":31,"type":32},206,"ESTIMATED",[34],{"type":14,"name":35,"description":36,"armGroupLabels":37},"Motivational Interviewing 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.",[38],"Performance feedback and facilitated practice",[40,44],{"measure":41,"description":42,"timeFrame":43},"General Help Seeking Questionnaire","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)",{"measure":45,"description":46,"timeFrame":43},"Patient Health Questionnaire-8","Measure helpline user distress. Minimum score = 0; Maximum score = 24. Higher scores indicate greater depressive symptom severity.",[],"ALL","13 Years",null,{"inclusion":52,"exclusion":65,"raw_text":68},[53,54,55,56,57,58,59,60,61,62,63,64],"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.","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).",[66,67],"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.","Inclusion Criteria\n\nTeen Helpers\n\n* Current helpline peer helpers\n* Aged 14-19 years.\n* Provides assent and documented parental consent (when applicable).\n* Completes study measures prior to the first Motivational Interviewing (MI) training session.\n* Attends and completes assigned MI training activities.\n* Has access to technology required for online participation (computer, tablet, or smartphone with internet access; videoconferencing capability if needed).\n* Plans to continue helpline activities throughout the study period.\n\nTeen Users\n\n* Aged 13-19 years.\n* Current U.S. resident.\n* Has engaged in at least 20 back-and-forth text exchanges with a helpline volunteer.\n* Demonstrates active communication and engagement on the helpline platform.\n* Has access to technology required to complete online surveys and, if selected, interviews (computer, tablet, or smartphone with internet access).\n\nExclusion Criteria\n\nTeen Helpers\n\n\\- Plans to discontinue helpline activities within the next 8 months.\n\nTeen Users\n\n* 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).\n* Requires immediate crisis intervention or emergency services that could be disrupted by participation in the research study.",[70,71,72],"CHILD","ADULT","OLDER_ADULT",[74],{"facility":13,"status":8,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":85},"San Diego","California","92182-8000","United States",[80],{"name":81,"role":82,"phone":83,"email":84},"Sylvanna M. Vargas, MPH, PhD","CONTACT","3057614632","svargas3@sdsu.edu",{"lat":86,"lon":87},32.71571,-117.16472,[],[],[],[],{"nct_id":4,"conditions":93,"biomarkers":95},[94],"Well male adolescent",[],{"nct_id":4,"found":15,"summary":97,"prompt_version":106},{"design":98,"status":99,"heading":6,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This is an interventional study planning to enroll 206 participants. Some participants will receive Motivational Interviewing training, and others will receive the training plus performance feedback and facilitated practice.","completed","This study is looking at how well a special training called Motivational Interviewing (MI) works for teen helpers on a text-based helpline. MI is a way of talking that helps people find their own reasons to make positive changes. The study wants to see if giving teen helpers this training, along with feedback and practice, helps the young people they talk to seek help more often and improve their mental health. You could join if you are a current helpline peer helper, aged 14-19. The study will measure how much help young people seek and their mental health symptoms after 11 months. The current status of the study is unclear.","Your help-seeking and mental health will be measured at 11 months after you join the study.",110,"You would complete study measures before training and attend and complete assigned Motivational Interviewing training activities. The enhanced training involves monthly feedback and practice sessions over 6 months.","Not stated in the trial record.",[],"v2"]