A Mobile Health Solution for Homework During CBT

Sponsor

University of South Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT04931199

Collaborator

National Institute of Mental Health (NIMH) (NIH)

140

Enrollment

Location

Arms

19.7

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to preliminarily evaluate a web-based app to improve provider implementation and patient engagement in homework (i.e., between-session practice of skills learned during therapy) during child mental health treatment by conducting a small-scale feasibility trial in community practice settings comparing Cognitive Behavioral Therapy (CBT) to CBT enhanced with the app.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Depression Posttraumatic Stress Disorder	Behavioral: Cognitive Behavioral Therapy (CBT) Behavioral: CBT+App	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Mobile Health Solution to Improve Between-Session Skills Practice in Youth Mental Health Treatment

Actual Study Start Date :

Jun 10, 2021

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CBT	Behavioral: Cognitive Behavioral Therapy (CBT) The standard of care procedures for children with clinically elevated anxiety, depression, and PTSD is traditional CBT from their mental health provider.
Experimental: CBT+App	Behavioral: CBT+App Participants receive CBT as usual enhanced with a simple, HIPAA compliant, web-based application to help mental health providers implement homework during CBT with children with elevated PTSD, anxiety, and/or depression, and their caregivers. The three major components of the app help providers to (1) Practice interactive, digitized CBT exercises with patients in-session; (2) Remind patients to practice CBT exercises for homework, and (3) Review homework during the next session.

Arm

Intervention/Treatment

Active Comparator: CBT

Behavioral: Cognitive Behavioral Therapy (CBT)

The standard of care procedures for children with clinically elevated anxiety, depression, and PTSD is traditional CBT from their mental health provider.

Experimental: CBT+App

Behavioral: CBT+App

Participants receive CBT as usual enhanced with a simple, HIPAA compliant, web-based application to help mental health providers implement homework during CBT with children with elevated PTSD, anxiety, and/or depression, and their caregivers. The three major components of the app help providers to (1) Practice interactive, digitized CBT exercises with patients in-session; (2) Remind patients to practice CBT exercises for homework, and (3) Review homework during the next session.

Outcome Measures

Primary Outcome Measures

Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y) [Baseline]
The Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y) is a 25-item self-report questionnaire that assesses levels of anxiety and depression in youth. Total, Total Anxiety, and Total Depression T-scores range from 0 to >80 with higher scores reflecting greater symptom severity.
Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y) [3-Months Post-Baseline]
The Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y) is a 25-item self-report questionnaire that assesses levels of anxiety and depression in youth. Total, Total Anxiety, and Total Depression T-scores range from 0 to >80 with higher scores reflecting greater symptom severity.
Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y) [6-Months Post-Baseline]
The Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y) is a 25-item self-report questionnaire that assesses levels of anxiety and depression in youth. Total, Total Anxiety, and Total Depression T-scores range from 0 to >80 with higher scores reflecting greater symptom severity.
Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P) [Baseline]
The Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P) is a 25-item caregiver-report questionnaire that assesses levels of anxiety and depression in youth. Total, Total Anxiety, and Total Depression T-scores range from 0 to >80 with higher scores reflecting greater symptom severity.
Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P) [3-Months Post-Baseline]
The Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P) is a 25-item caregiver-report questionnaire that assesses levels of anxiety and depression in youth. Total, Total Anxiety, and Total Depression T-scores range from 0 to >80 with higher scores reflecting greater symptom severity.
Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P) [6-Months Post-Baseline]
The Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P) is a 25-item caregiver-report questionnaire that assesses levels of anxiety and depression in youth. Total, Total Anxiety, and Total Depression T-scores range from 0 to >80 with higher scores reflecting greater symptom severity.
Child and Adolescent Trauma Screen - Youth Report (CATS-Y) [Baseline]
The Child and Adolescent Trauma Screen - Youth Report (CATS-Y) is a 25-item self-report questionnaire that assesses levels of post traumatic distress in youth. Total scores range from 0 to 60 with higher scores reflecting greater symptom severity.
Child and Adolescent Trauma Screen - Youth Report (CATS-Y) [3-Months Post-Baseline]
The Child and Adolescent Trauma Screen - Youth Report (CATS-Y) is a 25-item self-report questionnaire that assesses levels of post traumatic distress in youth. Total scores range from 0 to 60 with higher scores reflecting greater symptom severity.
Child and Adolescent Trauma Screen - Youth Report (CATS-Y) [6-Months Post-Baseline]
The Child and Adolescent Trauma Screen - Youth Report (CATS-Y) is a 25-item self-report questionnaire that assesses levels of post traumatic distress in youth. Total scores range from 0 to 60 with higher scores reflecting greater symptom severity.
Child and Adolescent Trauma Screen - Caregiver Report (CATS-P) [Baseline]
The Child and Adolescent Trauma Screen - Caregiver Report (CATS-P) is a 25-item caregiver-report questionnaire that assesses levels of post traumatic distress in youth. Total scores range from 0 to 60 with higher scores reflecting greater symptom severity.
Child and Adolescent Trauma Screen - Caregiver Report (CATS-P) [3-Months Post-Baseline]
The Child and Adolescent Trauma Screen - Caregiver Report (CATS-P) is a 25-item caregiver-report questionnaire that assesses levels of post traumatic distress in youth. Total scores range from 0 to 60 with higher scores reflecting greater symptom severity.
Child and Adolescent Trauma Screen - Caregiver Report (CATS-P) [6-Months Post-Baseline]
The Child and Adolescent Trauma Screen - Caregiver Report (CATS-P) is a 25-item caregiver-report questionnaire that assesses levels of post traumatic distress in youth. Total scores range from 0 to 60 with higher scores reflecting greater symptom severity.

Secondary Outcome Measures

Homework Rating Scale II (HRS II) [Weekly between Baseline and 3-Months Post-Baseline]
The Homework Rating Scale II (HRS II) is a 4-item self-report questionnaire that assesses levels of homework adherence in cognitive behavior therapy. Total scores range from 0 to 8 with higher scores reflecting greater homework adherence.
Homework Adherence and Competence Scale (HAACS) [Weekly between Baseline and 3-Months Post-Baseline]
The Homework Adherence and Competence Scale (HAACS) is a 19-item independent evaluator-rated instrument that assesses therapists' adherence and competence in reviewing, designing, and assigning homework assignments in cognitive behavior therapy. Total scores range from 0 to 30 for Reviewing homework, 0 to 54 for Designing homework, and 0 to 30 for Assigning homework, with higher scores reflecting greater adherence/competence.
Cognitive Behavioural subscale of the Comparative Psychotherapy Process Scale (CPPS-CB) [Weekly between Baseline and 3-Months Post-Baseline]
The Cognitive Behavioural subscale of the Comparative Psychotherapy Process Scale (CPPS-CB) is a 10-item independent evaluator-rated instrument that assesses therapist activity, process and techniques used in a psychotherapy session. Total scores range from 0 to 60 with higher scores reflecting better therapist performance.
Child and Adolescent Disruptive Behavior Inventory (CADBI) [Baseline]
The Child and Adolescent Disruptive Behavior Inventory (CADBI) is a 25-item caregiver-report questionnaire that assesses levels of post traumatic distress in youth. Total scores range from 0 to 200 with higher scores reflecting greater symptom severity.
Child and Adolescent Disruptive Behavior Inventory (CADBI) [3-Months Post-Baseline]
The Child and Adolescent Disruptive Behavior Inventory (CADBI) is a 25-item caregiver-report questionnaire that assesses levels of post traumatic distress in youth. Total scores range from 0 to 200 with higher scores reflecting greater symptom severity.
Child and Adolescent Disruptive Behavior Inventory (CADBI) [6-Months Post-Baseline]
The Child and Adolescent Disruptive Behavior Inventory (CADBI) is a 25-item caregiver-report questionnaire that assesses levels of post traumatic distress in youth. Total scores range from 0 to 200 with higher scores reflecting greater symptom severity.
KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y) [Baseline]
The KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y is a 10-item self-report questionnaire that assesses levels of quality of life in youth. Total T-scores range from 0 to >80 with higher scores reflecting greater quality of life.
KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y) [3-Months Post-Baseline]
The KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y is a 10-item self-report questionnaire that assesses levels of quality of life in youth. Total T-scores range from 0 to >80 with higher scores reflecting greater quality of life.
KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y) [6-Months Post-Baseline]
The KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y is a 10-item self-report questionnaire that assesses levels of quality of life in youth. Total T-scores range from 0 to >80 with higher scores reflecting greater quality of life.
KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P) [Baseline]
The KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P) is a 10-item caregiver-report questionnaire that assesses levels of quality of life in youth. Total T-scores range from 0 to >80 with higher scores reflecting greater quality of life.
KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P) [3-Months Post-Baseline]
The KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P) is a 10-item caregiver-report questionnaire that assesses levels of quality of life in youth. Total T-scores range from 0 to >80 with higher scores reflecting greater quality of life.
KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P) [6-Months Post-Baseline]
The KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P) is a 10-item caregiver-report questionnaire that assesses levels of quality of life in youth. Total T-scores range from 0 to >80 with higher scores reflecting greater quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Providers:

English-speaking
Mental health providers who have obtained at least a master's degree in social work, counseling, clinical psychology, or related field
Carry active child mental health treatment caseloads
Have a laptop, tablet, or smartphone with internet access

Youth:

English-speaking
Youth Ages 7-17 years
Clinically elevated anxiety and depression as indicated by a T-score ≥ 65 on the Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y) and/or Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P) or total score ≥ 15 on the Child and Adolescent Trauma Screen - Youth Report (CATS-Y) and/or Child and Adolescent Trauma Screen - Caregiver Report (CATS-P)
Have a laptop, tablet, or smartphone with internet access

Caregivers:

English-speaking
Adult (≥18 years old)
Caregivers of a youth who meets eligibility criteria
Have internet and smartphone access.

Exclusion Criteria:

Youth with self- or caregiver-reported:

Active psychotic symptoms (e.g., hallucinations, delusions)
Significant cognitive disability, developmental delays, or pervasive developmental disorder.