Digital Single Session Intervention for Youth Mental Health

This study is testing a digital program called "Practicing the Opposite (PTO)" for young people aged 9 to 17 who are waiting for mental health treatment. This program, lasting 30-45 minutes, aims to help with anxiety, depression, conduct disorder, and stress. Some participants will receive this digital program, while others will receive the usual care from their mental health clinic. Researchers want to see if the PTO program helps young people feel better and improves their engagement with future treatment. Success will be measured by changes in surveys about behavior and feelings, as well as scales for anxiety (GAD-7) and depression (PHQ-8). The study is currently recruiting up to 226 participants.

Study design
This interventional study plans to enroll 226 participants aged 9-17. It compares a digital program to usual clinical care.
What's involved
Participants will complete a 30-45 minute digital program or receive usual care. They will also complete surveys at the start, after the intervention, and then at 2 weeks and monthly until clinic treatment ends or for up to one year.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through post-intervention, 2-week, and monthly follow-up until completion of clinic treatment or 1 year, whichever comes first.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05449002

Digital Single Session Intervention for Youth Mental Health

Active, Not Recruiting
NAAges 9–17InterventionalTreatment
Harvard University
~226 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Practicing the Opposite (PTO)Usual Clinical Care

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Behavior and Feelings Survey (Youth and Parent Versions)
Measured over 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.
+3 more outcomes measured
Anxiety
Depression
Conduct Disorder
Stress
5 sites across 2 states
Massachusetts4
Indiana1
  • Katherine Venturo-Conerly, A.B. · PRINCIPAL_INVESTIGATOR · Harvard University

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Youth/family has contacted a participating outpatient clinic to seek mental health care, and is placed on the waitlist.
Youth is between the ages of 9-17 years (inclusive) at the time of study enrollment.
Youth and at least one guardian consent to the youth's participation in study.
Youth reads English well enough to effectively complete the digital programs (defined as taking classes in English, as opposed to ESL classes).
Youth has access to a digital device.

Exclusion

Youth is non-English speaking, as the program is only available in English.
Youth does not have access to a digital device.
  • Behavior and Feelings Survey (Youth and Parent Versions)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.

    Assesses the child's thoughts and feelings over the past week using both youth and parent report. Both the youth and parent report surveys include 12 items each scored from 04, with higher scores indicating more severe symptoms. Consists of an internalizing and externalizing subscale, the trajectories of which will be analyzed separately and compared between the intervention and control group. Note that timing described below may be adjusted if response or feedback suggests excessive measurement burden.

  • Generalized Anxiety Disorder 7-item scale (GAD-7)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.

    Assesses via a 7-item youth self-report questionnaire (in which scores range from 0-21, and higher scores indicate more severe symptoms) the youth's experience of anxiety symptoms. Trajectory of change on this measure will be compared between the intervention and control group. Note that timing described below may be adjusted if response or feedback suggests excessive measurement burden.

  • Patient Health Questionnaire 8-item scale (PHQ-8)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.

    Assesses via an 8-item youth self-report questionnaire (in which scores range from 0-24, and higher scores indicate more severe symptoms) the youth's experience of anxiety symptoms. Trajectory of change on this measure will be compared between the intervention and control group. Note that timing described below may be adjusted if response or feedback suggests excessive measurement burden.

  • Revised Children's Anxiety and Depression Scale (RCADS) Parent Version (Short Form)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.

    Trajectory of change on this 24-item parent-report measure of anxiety and depression (in which scores range from 0-72 and higher scores indicate more severe symptoms) will be compared between the intervention and control group. Trajectories of change on the subscales within this measure (broad anxiety and depression) may also be analyzed similarly. Note that timing described below may be adjusted if response or feedback suggests excessive measurement burden.