A Mobile Health Solution for Homework During CBT

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety, Depression, Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy (CBT)
* Behavioral: CBT+App


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBT<br> | Behavioral: Cognitive Behavioral Therapy (CBT)<br>* The standard of care procedures for children with clinically elevated anxiety, depression, and PTSD is traditional CBT from their mental health provider.<br>|
| Experimental: CBT+App<br> | Behavioral: CBT+App<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mhealth, mental health, youth mental health, adolescent mental health, homework