Clinical trial NCT04931199: A Mobile Health Solution for Homework During CBT
Official title: A Mobile Health Solution to Improve Between-Session Skills Practice in Youth Mental Health Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Posttraumatic Stress Disorder
Keywords: mhealth
mental health
youth mental health
adolescent mental health
homework
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-06-18
Enrollment: 86
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y)
timeFrame: Baseline
measure: Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y)
timeFrame: 3-Months Post-Baseline
measure: Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y)
timeFrame: 6-Months Post-Baseline
measure: Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P)
timeFrame: Baseline
measure: Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P)
timeFrame: 3-Months Post-Baseline
measure: Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P)
timeFrame: 6-Months Post-Baseline
measure: Child and Adolescent Trauma Screen - Youth Report (CATS-Y)
timeFrame: Baseline
measure: Child and Adolescent Trauma Screen - Youth Report (CATS-Y)
timeFrame: 3-Months Post-Baseline
measure: Child and Adolescent Trauma Screen - Youth Report (CATS-Y)
timeFrame: 6-Months Post-Baseline
measure: Child and Adolescent Trauma Screen - Caregiver Report (CATS-P)
timeFrame: Baseline
measure: Child and Adolescent Trauma Screen - Caregiver Report (CATS-P)
timeFrame: 3-Months Post-Baseline
measure: Child and Adolescent Trauma Screen - Caregiver Report (CATS-P)
timeFrame: 6-Months Post-Baseline
Secondary outcomes:
measure: Homework Rating Scale II (HRS II)
timeFrame: Weekly between Baseline and 3-Months Post-Baseline
measure: Homework Adherence and Competence Scale (HAACS)
timeFrame: Weekly between Baseline and 3-Months Post-Baseline
measure: Child and Adolescent Disruptive Behavior Inventory (CADBI)
timeFrame: Baseline
measure: Child and Adolescent Disruptive Behavior Inventory (CADBI)
timeFrame: 3-Months Post-Baseline
measure: Child and Adolescent Disruptive Behavior Inventory (CADBI)
timeFrame: 6-Months Post-Baseline
measure: KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y)
timeFrame: Baseline
measure: KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y)
timeFrame: 3-Months Post-Baseline
measure: KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y)
timeFrame: 6-Months Post-Baseline
measure: KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P)
timeFrame: Baseline
measure: KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P)
timeFrame: 3-Months Post-Baseline
measure: KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P)
timeFrame: 6-Months Post-Baseline
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 3-Months Post-Baseline
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 6-Months Post-Baseline
measure: Patient Health Questionnaire-8 (PHQ-8)
timeFrame: Baseline
measure: Patient Health Questionnaire-8 (PHQ-8)
timeFrame: 3-Months Post-Baseline
measure: Patient Health Questionnaire-8 (PHQ-8)
timeFrame: 6-Months Post-Baseline
measure: Working Alliance Inventory - Short Revised - Client Version (WAI-SR)
timeFrame: 3-Months Post-Baseline
measure: Child/Adolescent Satisfaction Questionnaire (CASQ-Y)
timeFrame: 3-Months Post-Baseline
measure: Caregiver Satisfaction Questionnaire (CSQ-P)
timeFrame: 3-Months Post-Baseline
measure: Attitudes Toward Homework Questionnaire (ATHQ)
timeFrame: Baseline
measure: Attitudes Toward Homework Questionnaire (ATHQ)
timeFrame: 3-Months Post-Baseline
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
References: