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Clinical Trials/NCT04931199
NCT04931199
Completed
N/A

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

University of South Florida1 site in 1 country86 target enrollmentJune 10, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety
Sponsor
University of South Florida
Enrollment
86
Locations
1
Primary Endpoint
Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y)
Status
Completed
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
June 10, 2021
End Date
August 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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)

Study Sites (1)

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