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Digital Single Session Intervention for Youth Mental Health

Primary Purpose

Anxiety, Depression, Conduct Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Practicing the Opposite (PTO)
Usual Clinical Care
Sponsored by
Harvard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

9 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Youth/family has contacted a participating Boston area 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.

Sites / Locations

  • Riley Child Psychiatry and Behavioral Sciences ClinicRecruiting
  • Boston Child Study CenterRecruiting
  • The Baker Center for Children and FamiliesRecruiting
  • The Concord CenterRecruiting
  • Riverside Community Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Practicing the Opposite (PTO) intervention

Usual waitlist control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
June 30, 2022
Last Updated
September 21, 2023
Sponsor
Harvard University
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1. Study Identification

Unique Protocol Identification Number
NCT05449002
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Conduct Disorder, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
226 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Practicing the Opposite (PTO) intervention
Arm Type
Experimental
Arm 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.
Arm Title
Usual waitlist control group
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Practicing the Opposite (PTO)
Intervention Description
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
Other
Intervention Name(s)
Usual Clinical Care
Intervention Description
Usual care provided by participating youth mental health clinics in the United States.
Primary Outcome Measure Information:
Title
Behavior and Feelings Survey (Youth and Parent Versions)
Description
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.
Time Frame
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.
Title
Generalized Anxiety Disorder 7-item scale (GAD-7)
Description
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.
Time Frame
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.
Title
Patient Health Questionnaire 8-item scale (PHQ-8)
Description
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.
Time Frame
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.
Title
Revised Children's Anxiety and Depression Scale (RCADS) Parent Version (Short Form)
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Ecological Momentary Assessment (EMA) Survey
Description
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.
Time Frame
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.
Title
State Hope Scale
Description
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.
Time Frame
Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.
Title
Perceived Control Scale for Children
Description
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.
Time Frame
Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.
Title
Secondary Control Scale for Children
Description
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.
Time Frame
Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.
Title
Clinic Record Data
Description
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.
Time Frame
Through study completion, an anticipated average of 6-months
Other Pre-specified Outcome Measures:
Title
Feedback Questionnaire
Description
Elicits feedback from the youth about the digital practicing the opposite program.
Time Frame
immediately post-intervention
Title
Demographic Questionnaire
Description
Asks caregiver and youth for basic youth and family demographic information.
Time Frame
pre-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Venturo-Conerly, A.B.
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riley Child Psychiatry and Behavioral Sciences Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriella Rodríguez, PhD, HSPP
Phone
317-944-8162
Email
gabrodri@iu.edu
Facility Name
Boston Child Study Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Flynn
Phone
617-800-9610
Email
aflynn@bostonchildstudycenter.com
Facility Name
The Baker Center for Children and Families
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Tannenbaum, PsyD, ABPP
Phone
617-278-4252
Email
stannenbaum@bakercenter.org
Facility Name
The Concord Center
City
Concord
State/Province
Massachusetts
ZIP/Postal Code
01742
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Micco, PhD
Phone
978-405-2544
Email
jmicco@concordcbt.com
Facility Name
Riverside Community Care
City
Dedham
State/Province
Massachusetts
ZIP/Postal Code
02026
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

Digital Single Session Intervention for Youth Mental Health

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