NCT04931199

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

June 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

2.2 years

First QC Date

June 2, 2021

Last Update Submit

December 13, 2023

Conditions

AnxietyDepressionPosttraumatic Stress Disorder

Keywords

mhealthmental healthyouth mental healthadolescent mental healthhomework

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (22)

  • Homework Rating Scale II (HRS II)

    Weekly between Baseline and 3-Months Post-Baseline

  • Homework Adherence and Competence Scale (HAACS)

    Weekly between Baseline and 3-Months Post-Baseline

  • Child and Adolescent Disruptive Behavior Inventory (CADBI)

    Baseline

  • Child and Adolescent Disruptive Behavior Inventory (CADBI)

    3-Months Post-Baseline

  • Child and Adolescent Disruptive Behavior Inventory (CADBI)

    6-Months Post-Baseline

  • +17 more secondary outcomes

Study Arms (2)

CBT

ACTIVE COMPARATOR
Behavioral: Cognitive Behavioral Therapy (CBT)

CBT+App

EXPERIMENTAL
Behavioral: CBT+App

Interventions

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
CBT+AppBEHAVIORAL

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.

CBT+App

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Youth with self- or caregiver-reported:
  • Active psychotic symptoms (e.g., hallucinations, delusions)
  • Significant cognitive disability, developmental delays, or pervasive developmental disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

Tampa, Florida, 33613, United States

Location

MeSH Terms

Conditions

Anxiety DisordersDepressionStress Disorders, Post-TraumaticPsychological Well-Being

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 18, 2021

Study Start

June 10, 2021

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)