Skip to main content
OpenTrials
Completed

NCT Number: NCT04931199

A Mobile Health Solution for Homework During CBT

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Personal Satisfaction Posttraumatic Stress Disorder Psychological Well-Being Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida

Tampa, Florida, 33613, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Behavioral

The standard of care procedures for children with clinically elevated anxiety, depression, and PTSD is traditional CBT from their mental health provider.

CBT+App

Behavioral

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 3-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.

  3. 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.

  4. Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P)

    Time frame: 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.

  5. Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P)

    Time frame: 3-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.

  6. 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.

  7. Child and Adolescent Trauma Screen - Youth Report (CATS-Y)

    Time frame: 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.

  8. Child and Adolescent Trauma Screen - Youth Report (CATS-Y)

    Time frame: 3-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.

  9. 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.

  10. Child and Adolescent Trauma Screen - Caregiver Report (CATS-P)

    Time frame: 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.

  11. Child and Adolescent Trauma Screen - Caregiver Report (CATS-P)

    Time frame: 3-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.

  12. 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.

Secondary outcomes

  1. Homework Rating Scale II (HRS II)

    Time frame: 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.

  2. Homework Adherence and Competence Scale (HAACS)

    Time frame: 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.

  3. Child and Adolescent Disruptive Behavior Inventory (CADBI)

    Time frame: 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.

  4. Child and Adolescent Disruptive Behavior Inventory (CADBI)

    Time frame: 3-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.

  5. Child and Adolescent Disruptive Behavior Inventory (CADBI)

    Time frame: 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.

  6. KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y)

    Time frame: 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.

  7. KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y)

    Time frame: 3-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.

  8. KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y)

    Time frame: 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.

  9. KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P)

    Time frame: 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.

  10. KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P)

    Time frame: 3-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.

  11. KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P)

    Time frame: 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.

  12. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 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

  13. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 3-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

  14. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 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

  15. Patient Health Questionnaire-8 (PHQ-8)

    Time frame: 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

  16. Patient Health Questionnaire-8 (PHQ-8)

    Time frame: 3-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

  17. Patient Health Questionnaire-8 (PHQ-8)

    Time frame: 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

  18. Working Alliance Inventory - Short Revised - Client Version (WAI-SR)

    Time frame: 3-Months Post-Baseline

    The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item measure for the assessment of the therapeutic alliance.

  19. Child/Adolescent Satisfaction Questionnaire (CASQ-Y)

    Time frame: 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:

  20. Caregiver Satisfaction Questionnaire (CSQ-P)

    Time frame: 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

  21. Attitudes Toward Homework Questionnaire (ATHQ)

    Time frame: Baseline

    A self-report assessing practitioners' demographic characteristics, use of homework assignments and attitudes towards the use of homework assignments in psychotherapy

  22. Attitudes Toward Homework Questionnaire (ATHQ)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2021
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.