Digital Single Session Intervention for Youth Mental Health
Part of paid clinical trials in Indianapolis, Indiana.
- Sponsor
- Harvard University
- Study ID
- NCT05449002
- Status
- Active Not Recruiting
Conditions
- Anxiety
- Conduct Disorder
- Depression
- Stress
Eligibility Criteria
- Sex
- ALL
- Age
- 9 Years - 17 Years
- Healthy Volunteers
- Accepted
Interventions
- Practicing the Opposite (PTO) — BEHAVIORALThis 30-45-minute digital program is designed to help youths on the waitlist feel better prior to treatment and may also improve their treatment engagement and outcomes.
- Usual Clinical Care — OTHERUsual care provided by participating youth mental health clinics in the United States.
Study Details
The aim of this study is to test the effectiveness of a single-session, digital intervention teaching the principle of practicing the opposite, when administered to youths on the waitlist for psychotherapy, with usual waitlist procedures as a control condition.
Key Dates
- Start date
- Sep 5, 2022
- Status verified
- Jun 2026
- Primary completion
- May 31, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 226 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Practicing the Opposite (PTO) interventionThis 30-45 minutes Qualtrics-based, digital program uses stories, interactive activities, and engaging graphics to teach youths one core principle: by practicing the positive opposite of unhelpful behaviors (e.g., engaging with rather than avoiding feared stimuli), one can, over time, change their mood, thoughts, and actions. The intervention is comprised of four main sections: 1) An introduction to PTO; (2) Testimonials from young people who have been helped by PTO; (3) Learning how to Practice the Opposite through online activities. (4) Planning how to continue to Practice the Opposite in the participant's life. Of note, after being removed from the waitlist at the clinic and contacted to begin treatment, participants will still receive treatment as usual from the clinic.
- Other: Usual waitlist control groupUsual waitlist procedures involve watchful waiting for a therapist to become available, sometimes complemented by periodic check-ins from the family with clinic administrators. After being removed from the waitlist and contacted to begin treatment, participants in both study conditions will receive treatment as usual in the clinic.
Primary Outcome Measure
Behavior and Feelings Survey (Youth and Parent Versions) [ Time Frame: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and monthly follow-up until completion of clinic treatment or 1 year, whichever comes first. ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Riley Child Psychiatry and Behavioral Sciences Clinic | Indianapolis | Indiana | 46202 | - |
| Boston Child Study Center | Boston | Massachusetts | 02116 | - |
| The Baker Center for Children and Families | Boston | Massachusetts | 02120 | - |
| The Concord Center | Concord | Massachusetts | 01742 | - |
| Riverside Community Care | Dedham | Massachusetts | 02026 | - |
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