A Mobile Health Solution for Homework During CBT

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder; Depression; Anxiety

• Registration Number: NCT04931199
• Lead Sponsor: University of South Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-02
• Study Start: 2021-06-10
• Study First Submitted QC: 2021-06-16
• Study First Posted: 2021-06-18
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
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.
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)	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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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)	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.
Generalized Anxiety Disorder-7 (GAD-7)	6-Months Post-Baseline	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
Patient Health Questionnaire-8 (PHQ-8)	6-Months Post-Baseline	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
Working Alliance Inventory - Short Revised - Client Version (WAI-SR)	3-Months Post-Baseline	The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item measure for the assessment of the therapeutic alliance.
Child/Adolescent Satisfaction Questionnaire (CASQ-Y)	3-Months Post-Baseline	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:
Caregiver Satisfaction Questionnaire (CSQ-P)	3-Months Post-Baseline	Client Satisfaction Questionnaire (CSQ-8) examines the level of consumer satisfaction with children's (ages 8 to 17 years) outpatient mental health services
Attitudes Toward Homework Questionnaire (ATHQ)	3-Months Post-Baseline	A self-report assessing practitioners' demographic characteristics, use of homework assignments and attitudes towards the use of homework assignments in psychotherapy

Trial Locations

Locations (1)

University of South Florida; 🇺🇸 Tampa, Florida, United States