Clinical trial NCT05449002: Digital Single Session Intervention for Youth Mental Health
Official title: Testing a Digital Single-session Intervention for Youths on the Waitlist for Psychotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Conduct Disorder
Stress
Lead sponsor: Harvard University
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 226
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Behavior and Feelings Survey (Youth and Parent Versions)
timeFrame: 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.
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: 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.
measure: Patient Health Questionnaire 8-item scale (PHQ-8)
timeFrame: 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.
measure: Revised Children's Anxiety and Depression Scale (RCADS) Parent Version (Short Form)
timeFrame: 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:
measure: Ecological Momentary Assessment (EMA) Survey
timeFrame: 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.
measure: State Hope Scale
timeFrame: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.
measure: Perceived Control Scale for Children
timeFrame: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.
measure: Secondary Control Scale for Children
timeFrame: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.
measure: Clinic Record Data
timeFrame: Through study completion, an anticipated average of 6-months
Other outcomes:
measure: Feedback Questionnaire
timeFrame: immediately post-intervention
measure: Demographic Questionnaire
timeFrame: pre-intervention
Locations:
city: Indianapolis
country: United States
facility: Riley Child Psychiatry and Behavioral Sciences Clinic
state: Indiana
city: Boston
country: United States
facility: Boston Child Study Center
state: Massachusetts
city: Boston
country: United States
facility: The Baker Center for Children and Families
state: Massachusetts
city: Concord
country: United States
facility: The Concord Center
state: Massachusetts
city: Dedham
country: United States
facility: Riverside Community Care
state: Massachusetts
Study officials:
affiliation: Harvard University
name: Katherine Venturo-Conerly, A.B.
role: PRINCIPAL_INVESTIGATOR
References: