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Clinical Trials/NCT04931199
NCT04931199CompletedNot Applicable

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

University of South Florida2 sites in 1 country86 target enrollmentStarted: June 10, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
86
Locations
2
Primary Endpoint
Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
7 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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
  • 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.

Outcomes

Primary Outcomes

Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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 Outcomes

  • KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P)(6-Months Post-Baseline)
  • Homework Rating Scale II (HRS II)(Weekly between Baseline and 3-Months Post-Baseline)
  • Homework Adherence and Competence Scale (HAACS)(Weekly between Baseline and 3-Months Post-Baseline)
  • Child and Adolescent Disruptive Behavior Inventory (CADBI)(6-Months Post-Baseline)
  • KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y)(6-Months Post-Baseline)
  • Generalized Anxiety Disorder-7 (GAD-7)(6-Months Post-Baseline)
  • Patient Health Questionnaire-8 (PHQ-8)(6-Months Post-Baseline)
  • Working Alliance Inventory - Short Revised - Client Version (WAI-SR)(3-Months Post-Baseline)
  • Child/Adolescent Satisfaction Questionnaire (CASQ-Y)(3-Months Post-Baseline)
  • Caregiver Satisfaction Questionnaire (CSQ-P)(3-Months Post-Baseline)
  • Attitudes Toward Homework Questionnaire (ATHQ)(3-Months Post-Baseline)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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