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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04931199
Other study ID # 002313
Secondary ID K23MH118482
Status Completed
Phase N/A
First received
Last updated
Start date June 10, 2021
Est. completion date August 31, 2023

Study information

Verified date December 2023
Source University of South Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 7 Years to 17 Years
Eligibility 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


Intervention

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.
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.

Locations

Country Name City State
United States University of South Florida Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
University of South Florida National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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