Digital Single Session Intervention for Youth Mental Health

NCT05449002 | Recruiting

• 1 other identifier: IRB22-0101
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Anxiety; Depression; Conduct Disorder; Stress

Outcome Measures

Primary Outcomes (4)

• Behavior and Feelings Survey (Youth and Parent Versions)

  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.

  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.

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

  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.

  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.

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

  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.

  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.

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

  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.

  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.

Secondary Outcomes (5)

• Ecological Momentary Assessment (EMA) Survey

  Scores on each item will be compared across 1 week before the PTO intervention and 2-weeks after. The association between change in behaviors and change in affect across these time ranges will be assessed.

• State Hope Scale

  Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.

• Perceived Control Scale for Children

  Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.

• Secondary Control Scale for Children

  Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.

• Clinic Record Data

  Through study completion, an anticipated average of 6-months

Other Outcomes (2)

• Feedback Questionnaire

  immediately post-intervention

• Demographic Questionnaire

  pre-intervention

Study Arms (2)

Practicing the Opposite (PTO) intervention

EXPERIMENTAL

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.

Behavioral: Practicing the Opposite (PTO)

Usual waitlist control group

OTHER

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.

Other: Usual Clinical Care

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.

Practicing the Opposite (PTO) intervention

Usual Clinical Care OTHER

Usual care provided by participating youth mental health clinics in the United States.

Usual waitlist control group

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Youth is non-English speaking, as the program is only available in English.
• Youth does not have access to a digital device.

Sponsors & Collaborators

• Harvard University: lead

Study Sites (5)

Riley Child Psychiatry and Behavioral Sciences Clinic

Indianapolis, Indiana, 46202, United States

RECRUITING

Boston Child Study Center

Boston, Massachusetts, 02116, United States

RECRUITING

The Baker Center for Children and Families

Boston, Massachusetts, 02120, United States

RECRUITING

The Concord Center

Concord, Massachusetts, 01742, United States

RECRUITING

Riverside Community Care

Dedham, Massachusetts, 02026, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression; Conduct Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Study Officials

• Katherine Venturo-Conerly, A.B.

  Harvard University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Venturo-Conerly, A.M.

CONTACT

609-954-0542; kventuroconerly@g.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants, 9-17 years old, will be: randomized to a 30-45-minute Qualtrics-based, digital program teaching Practicing the Opposite (PTO, followed by psychotherapy) or to the usual care (i.e., usual waitlist procedures, followed by psychotherapy) control.

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 8, 2022
• Study Start: September 5, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

US (5)