Digital Single Session Intervention for Youth Mental Health

President and Fellows of Harvard College

Status: Enrolling

Conditions: Conduct Disorder; Depression; Anxiety; Stress

Treatments: Other: Usual Clinical Care; Behavioral: Practicing the Opposite (PTO)

Study type: Interventional

Funder types: Other

Identifiers

NCT05449002

IRB22-0101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 226 estimated patients

Sex: All

Ages: 9 to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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226 participants in 2 patient groups

Practicing the Opposite (PTO) intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Practicing the Opposite (PTO)

Usual waitlist control group

Other group

Description:

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.

Treatment:

Other: Usual Clinical Care