Digital Single Session Intervention for Youth Mental Health

Depression Clinical Trial

Official title:

Testing a Digital Single-session Intervention for Youths on the Waitlist for Psychotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05449002
• Other study ID #: IRB22-0101
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: September 2023
• Source: Harvard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 226
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Conduct Disorder
• Depression
• Stress

Intervention

Behavioral:
• 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.

Other:
• Usual Clinical Care
Usual care provided by participating youth mental health clinics in the United States.

Locations

Country	Name	City	State
United States	Boston Child Study Center	Boston	Massachusetts
United States	The Baker Center for Children and Families	Boston	Massachusetts
United States	The Concord Center	Concord	Massachusetts
United States	Riverside Community Care	Dedham	Massachusetts
United States	Riley Child Psychiatry and Behavioral Sciences Clinic	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Harvard University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feedback Questionnaire	Elicits feedback from the youth about the digital practicing the opposite program.	immediately post-intervention
Other	Demographic Questionnaire	Asks caregiver and youth for basic youth and family demographic information.	pre-intervention
Primary	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.
Primary	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.
Primary	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.
Primary	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	Ecological Momentary Assessment (EMA) Survey	Consisting of a modified Positive and Negative Affect Scale (PANAS) and a modified Coping Questionnaire, this 8-item measure is administered 3 times daily via an EMA mobile application called Metricwire. It assesses affect and behaviors via youth self-report.	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.
Secondary	State Hope Scale	Assesses the child's current level of hope using a six-item self-report scale, in which each item is scored from 1 to 8, with higher scores indicating greater hope. 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 1-month follow-up.
Secondary	Perceived Control Scale for Children	Assesses via a 24-item self-report scale the youth's beliefs about their ability to control and change their environment. Total scores range from 0-72, with higher scores indicating greater perceived control. 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 1-month follow-up.
Secondary	Secondary Control Scale for Children	Assesses via a 20-item self-report scale the youth's beliefs about their ability to control and change their emotions and thoughts. Total scores range from 0-60, with higher scores indicating greater secondary control. 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 1-month follow-up.
Secondary	Clinic Record Data	For those participants who authorize investigator access to their clinic record data, the investigators will also compare rates of accessing and completing clinic treatment, as well as attendance at sessions, between the intervention and control groups.	Through study completion, an anticipated average of 6-months