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A Mobile Health Solution for Homework During CBT

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ClinicalTrials.gov Identifier: NCT04931199
Recruitment Status : Recruiting
First Posted : June 18, 2021
Last Update Posted : May 23, 2022
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anxiety Depression Posttraumatic Stress Disorder Behavioral: Cognitive Behavioral Therapy (CBT) Behavioral: CBT+App Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Mobile Health Solution to Improve Between-Session Skills Practice in Youth Mental Health Treatment
Actual Study Start Date : June 10, 2021
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CBT 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.

Experimental: CBT+App Behavioral: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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. Cognitive Behavioural subscale of the Comparative Psychotherapy Process Scale (CPPS-CB) [ Time Frame: Weekly between Baseline and 3-Months Post-Baseline ]
    The Cognitive Behavioural subscale of the Comparative Psychotherapy Process Scale (CPPS-CB) is a 10-item independent evaluator-rated instrument that assesses therapist activity, process and techniques used in a psychotherapy session. Total scores range from 0 to 60 with higher scores reflecting better therapist performance.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04931199


Contacts
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Contact: Brian E Bunnell, PhD 8139748607 bbunnell@usf.edu
Contact: Janelle F Barrera, MPH 8132962961 jfb@usf.edu

Locations
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United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33613
Contact: Janelle Barrera, MPH    813-296-2961    jfb@usf.edu   
Principal Investigator: Brian E Bunnell, PhD         
Sponsors and Collaborators
University of South Florida
National Institute of Mental Health (NIMH)
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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT04931199    
Other Study ID Numbers: 002313
K23MH118482 ( U.S. NIH Grant/Contract )
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of South Florida:
mhealth
mental health
youth mental health
adolescent mental health
homework
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders