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

Eligibility Criteria

Sex
ALL
Age
9 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • Practicing the Opposite (PTO) — BEHAVIORAL
    This 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 — OTHER
    Usual 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) intervention
    This 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 group
    Usual 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)

FacilityCityStateZIPSite coordinators
Riley Child Psychiatry and Behavioral Sciences ClinicIndianapolisIndiana46202-
Boston Child Study CenterBostonMassachusetts02116-
The Baker Center for Children and FamiliesBostonMassachusetts02120-
The Concord CenterConcordMassachusetts01742-
Riverside Community CareDedhamMassachusetts02026-

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