A Mobile Health Solution for Homework During CBT

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: CBT+App

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33613
      • University of South Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y)	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.	Baseline
Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y)	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.	3-Months Post-Baseline
Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y)	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.	6-Months Post-Baseline
Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P)	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.	Baseline
Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P)	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.	3-Months Post-Baseline
Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P)	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.	6-Months Post-Baseline
Child and Adolescent Trauma Screen - Youth Report (CATS-Y)	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.	Baseline
Child and Adolescent Trauma Screen - Youth Report (CATS-Y)	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.	3-Months Post-Baseline
Child and Adolescent Trauma Screen - Youth Report (CATS-Y)	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.	6-Months Post-Baseline
Child and Adolescent Trauma Screen - Caregiver Report (CATS-P)	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.	Baseline
Child and Adolescent Trauma Screen - Caregiver Report (CATS-P)	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.	3-Months Post-Baseline
Child and Adolescent Trauma Screen - Caregiver Report (CATS-P)	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.	6-Months Post-Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Homework Rating Scale II (HRS II)	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.	Weekly between Baseline and 3-Months Post-Baseline
Homework Adherence and Competence Scale (HAACS)	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.	Weekly between Baseline and 3-Months Post-Baseline
Child and Adolescent Disruptive Behavior Inventory (CADBI)	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.	Baseline
Child and Adolescent Disruptive Behavior Inventory (CADBI)	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.	3-Months Post-Baseline
Child and Adolescent Disruptive Behavior Inventory (CADBI)	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.	6-Months Post-Baseline
KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y)	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.	Baseline
KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y)	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.	3-Months Post-Baseline
KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y)	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.	6-Months Post-Baseline
KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P)	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.	Baseline
KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P)	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.	3-Months Post-Baseline
KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P)	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.	6-Months Post-Baseline
Generalized Anxiety Disorder-7 (GAD-7)	The Generalized Anxiety Disorder scale-7 (GAD-7) is a seven-item diagnostic tool validated in both the primary care setting and the general population	Baseline
Generalized Anxiety Disorder-7 (GAD-7)	The Generalized Anxiety Disorder scale-7 (GAD-7) is a seven-item diagnostic tool validated in both the primary care setting and the general population	3-Months Post-Baseline
Generalized Anxiety Disorder-7 (GAD-7)	The Generalized Anxiety Disorder scale-7 (GAD-7) is a seven-item diagnostic tool validated in both the primary care setting and the general population	6-Months Post-Baseline
Patient Health Questionnaire-8 (PHQ-8)	The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies	Baseline
Patient Health Questionnaire-8 (PHQ-8)	The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies	3-Months Post-Baseline
Patient Health Questionnaire-8 (PHQ-8)	The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies	6-Months Post-Baseline
Working Alliance Inventory - Short Revised - Client Version (WAI-SR)	The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item measure for the assessment of the therapeutic alliance.	3-Months Post-Baseline
Child/Adolescent Satisfaction Questionnaire (CASQ-Y)	CASQ is a 14 item questionnaire administered to children and youth involved with mental health services. It is identical to the parent version and measures three dimensions of satisfaction with mental health services:	3-Months Post-Baseline
Caregiver Satisfaction Questionnaire (CSQ-P)	Client Satisfaction Questionnaire (CSQ-8) examines the level of consumer satisfaction with children's (ages 8 to 17 years) outpatient mental health services	3-Months Post-Baseline
Attitudes Toward Homework Questionnaire (ATHQ)	A self-report assessing practitioners' demographic characteristics, use of homework assignments and attitudes towards the use of homework assignments in psychotherapy	Baseline
Attitudes Toward Homework Questionnaire (ATHQ)	A self-report assessing practitioners' demographic characteristics, use of homework assignments and attitudes towards the use of homework assignments in psychotherapy	3-Months Post-Baseline

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: mental health; mhealth; youth mental health; adolescent mental health; homework
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 002313; K23MH118482 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No