Anxiety, Depression, Posttraumatic Stress Disorder
Conditions
Keywords
mhealth, mental health, youth mental health, adolescent mental health, homework
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.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALCBT+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.
Sponsors
National Institute of Mental Health (NIMH)
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y) | 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. |
| Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P) | 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) | 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. |
| Child and Adolescent Trauma Screen - Caregiver Report (CATS-P) | 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
| Measure | Time frame | Description |
|---|---|---|
| KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P) | 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. |
| Generalized Anxiety Disorder-7 (GAD-7) | 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 |
| Patient Health Questionnaire-8 (PHQ-8) | 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 |
| Homework Rating Scale II (HRS II) | 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. |
| Child/Adolescent Satisfaction Questionnaire (CASQ-Y) | 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: |
| Caregiver Satisfaction Questionnaire (CSQ-P) | 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 |
| Attitudes Toward Homework Questionnaire (ATHQ) | Baseline | A self-report assessing practitioners' demographic characteristics, use of homework assignments and attitudes towards the use of homework assignments in psychotherapy |
| Working Alliance Inventory - Short Revised - Client Version (WAI-SR) | 3-Months Post-Baseline | The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item measure for the assessment of the therapeutic alliance. |
| Homework Adherence and Competence Scale (HAACS) | 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. |
| Child and Adolescent Disruptive Behavior Inventory (CADBI) | 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. |
| KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y) | 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. |
Countries
United States
Outcome results
None listed