Digital Single Session Intervention for Youth Mental Health

NCT ID: NCT05449002

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-05
• Study Completion Date: 2027-09-30

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.

Detailed Description

There is a massive unmet need for youth mental health care in America; only ¼ of youth in need receive services. The problem has been underscored and exacerbated by the pandemic. The need for child and adolescent mental health care, particularly for depression and anxiety, has surged while clinician availability and clinic funding have shrunk. One result is that clinic waitlists, always lengthy, have stretched, with youths and families who seek care waiting for up to 12 months for a first appointment, and many giving up and dropping out before the much-delayed appointment. There is a clear need-in both pandemic and normal times-for efficient mental health support that can be provided when need is acute, to sustain young people through periods of delayed access, and to reduce burden for professionals. Fortunately, recent evidence shows the surprising potential of brief, low-cost, digital interventions that could go a long way toward bridging the need-to-access gap. Single-session interventions have substantial effects, in some cases rivaling effects of full-length in-person psychotherapy. Remote therapies for youth mental health problems are beneficial on average and approximately as beneficial as in-person psychotherapy.

The current trial will test a brief (one 30-45-minute session), online, interactive mental health and behavior change intervention for adolescents (9-17 years old), who have been placed the waitlist for outpatient treatment at participating mental health clinics in the United States. Previous RCTs show beneficial effects of the principle of Practicing the Opposite (PTO) on youth mental health when using the therapeutic elements present in PTO (e.g., exposure, to overcome anxiety; behavioral activation, to overcome depression). The single-session PTO intervention uses stories, interactive activities, and engaging graphics to teach youths a key principle: by practicing the positive opposite of unhelpful behaviors, one can, over time, change their emotions thoughts, and actions.

Conditions

Anxiety; Depression; Conduct Disorder; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Practicing the Opposite (PTO)

Intervention Type: 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 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.

Group Type: OTHER

Usual Clinical Care

Intervention Type: OTHER

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

Interventions

Practicing the Opposite (PTO)

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.

Intervention Type: BEHAVIORAL

Usual Clinical Care

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harvard University

OTHER

Sponsor Role: lead

Responsible Party

Katherine Venturo-Conerly

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine Venturo-Conerly, A.B.

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Locations

Riley Child Psychiatry and Behavioral Sciences Clinic

Indianapolis, Indiana, United States

Site Status: RECRUITING

Boston Child Study Center

Boston, Massachusetts, United States

Site Status: RECRUITING

The Baker Center for Children and Families

Boston, Massachusetts, United States

Site Status: RECRUITING

The Concord Center

Concord, Massachusetts, United States

Site Status: RECRUITING

Riverside Community Care

Dedham, Massachusetts, United States

Site Status: ACTIVE_NOT_RECRUITING

Countries

United States

Central Contacts

Katherine Venturo-Conerly, A.M.

Role: CONTACT

kventuroconerly@g.harvard.edu

609-954-0542

Facility Contacts

Gabriella Rodríguez, PhD, HSPP

Role: primary

gabrodri@iu.edu

3179448162

Ashley Flynn

Role: primary

aflynn@bostonchildstudycenter.com

617-800-9610

Sarah Tannenbaum, PsyD, ABPP

Role: primary

stannenbaum@bakercenter.org

(617) 278-4252

Jamie Micco, PhD

Role: primary

jmicco@concordcbt.com

(978) 405-2544

Other Identifiers

IRB22-0101

Identifier Type: -

Identifier Source: org_study_id