Family-Focused CBT Skills App and Standard Self Help Options for Childhood Anxiety

August 31, 2020 updated by: Kansas City Center for Anxiety Treatment, P.A.

Randomized Controlled Trial of a Family-focused CBT Skills App and Standard Self Help Options for Childhood Anxiety and Related Conditions

Anxiety disorders are among the most common psychological disorders, with prevalent onset in childhood and adolescence. While cognitive behavioral therapy (CBT) is considered the first-line treatment for pediatric anxiety, significant barriers remain in accessing CBT and other evidence-based treatments (EBTs), and credible self-help resources based in EBT concepts. This study evaluates a family-guided CBT game application (Anchors App), targeted to children ages 6-11 and their families, which focuses on delivering adaptive CBT-based coping skills to those who have sub-clinical to mild anxiety and related symptoms in a convenient and portable platform. Anchors App will be evaluated in two forms (standard and "parent-enhanced") in comparison to use of a self-help book or waitlist control. The rapid advancements in technology allows richer interactive capacity, content scalability, customizability, and subscription to a broader range of content, which this app capitalizes on in order to increase access to CBT skill concepts directly to pediatric stakeholder populations. If found to be effective, Anchors App has the opportunity to promote engagement of EBT concepts in every-day use through smartphone technology, and will change the landscape of mental health prevention and early intervention for children and families.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Kansas City Center for Anxiety Treatment, P.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Availability of mobile technology (e.g., smart phone, tablet)
  • Internet access
  • English language spoken in the home

Exclusion Criteria:

  • Child in current or recent (last 2 months) psychotherapy
  • Child currently taking psychotropic medication
  • Parent or child endorsing symptom greater than 2 standard deviations above the mean on clinical measures
  • Parents express feeling unable to assist child with current degree of symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1: Anchors Away
Family will receive access to the basic Anchors Away mobile app to test over 6 weeks.
Behavioral: Anchors Away
Modular Cognitive Behavioral Therapy delivered through a mobile app.
Experimental: 2: Parent Enhanced Anchors Away
Family will receive access to the Parent Enhanced Anchors Away mobile app to test over 6 weeks.
Behavioral: Parent Enhanced Anchors Away
Modular Cognitive Behavioral Therapy delivered through a mobile app. Extra modules will focus specifically on parenting skills relevant to having an anxious child.
Active Comparator: 3: Self-Help E-Book
Group 3 will receive the Self Help e-Book as a comparative condition (families provided a kindle version copy of "Helping Your Anxious Child: A Step-by-Step Guide" ; Rapee, Wignall, Spence, Lyneham, & Cobham, 2008).
Behavioral: Self-Help E-Book
Parents will read "Helping Your Anxious Child: A Step-by-Step Guide" (Rapee, Wignall, Spence, Lyneham, & Cobham, 2008)
No Intervention: 4: Waitlist Control
Group 4 will not receive any intervention, but will be randomized into an active study arm at 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spence Children's Anxiety Scale - Parent/Child Report (SCAS)
Time Frame: Entry into study, 6 weeks, 12 weeks
Parent and child report of anxiety with 6 DSM-IV criteria sub scales. Measuring change in reported anxiety levels in these 6 different domains over time.
Entry into study, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DASS-21
Time Frame: Entry into study, 6 weeks, 12 weeks
A screener for overall psychological distress of parent with sub scales assessing anxiety, depression, and stress.
Entry into study, 6 weeks, 12 weeks
Centre for Epidemiological Studies- Depression Scale for Children (CES-DC)
Time Frame: Entry into study, 6 weeks, 12 weeks
A 20-item screener for childhood depression and psychological distress
Entry into study, 6 weeks, 12 weeks
Anxiety Sensitivity Index- 3 (ASI-3)
Time Frame: Entry into study, 6 weeks, 12 weeks
A measure of parent anxiety sensitivity (fear of arousal-related sensations) in physical, social, and cognitive domains
Entry into study, 6 weeks, 12 weeks
Child Anxiety Sensitivity Index (CASI)
Time Frame: Entry into study, 6 weeks, 12 weeks
A measure of sensitivity to symptoms of anxiety, similar to the ASI, measuring physical, social, and mental incapacitation concerns in children.
Entry into study, 6 weeks, 12 weeks
Behavioral Inhibition Instrument (BII)
Time Frame: Entry into study, 6 weeks, 12 weeks
A parent-report measure of child behavioral inhibition, which has been determined to be a risk factor for later psychopathology, particularly anxiety.
Entry into study, 6 weeks, 12 weeks
Treatment Status and Parent Confidence
Time Frame: Entry into study, 3 weeks, 6 weeks, 12 weeks
Self-report measure to ensure the child is not receiving outside interventions (as would disqualify them from study) and to gauge parents' confidence in managing child's symptoms
Entry into study, 3 weeks, 6 weeks, 12 weeks
Opinion on Intervention
Time Frame: 6 weeks
Self-report measure to gauge families' thoughts on user-friendliness, perceived effectiveness of intervention, and likelihood to use again or recommend to others
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansas City Center for Anxiety Treatment, P.A.

Collaborators

Virtually Better, Inc.

Investigators

  • Principal Investigator: Margo Adams Larsen, PhD, Virtually Better, Inc.
  • Principal Investigator: Kathryn D Kriegshauser, PhD, Kansas City Center for Anxiety Treatment, P.A.
  • Principal Investigator: Lisa R Hale, PhD, Kansas City Center for Anxiety Treatment, P.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

August 29, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

August 31, 2017

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2R44MH098470-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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