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

NCT03269370 | Completed

• 1 other identifier: 2R44MH098470-03
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety Disorders; Childhood Mental Disorder; Anxiety

Keywords

CBT; Self-Help; Family

Outcome Measures

Primary Outcomes (1)

• Spence Children's Anxiety Scale - Parent/Child Report (SCAS)

  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 Outcomes (7)

• DASS-21

  Entry into study, 6 weeks, 12 weeks

• Centre for Epidemiological Studies- Depression Scale for Children (CES-DC)

  Entry into study, 6 weeks, 12 weeks

• Anxiety Sensitivity Index- 3 (ASI-3)

  Entry into study, 6 weeks, 12 weeks

• Child Anxiety Sensitivity Index (CASI)

  Entry into study, 6 weeks, 12 weeks

• Behavioral Inhibition Instrument (BII)

  Entry into study, 6 weeks, 12 weeks

Study Arms (4)

1: Anchors Away

EXPERIMENTAL

Family will receive access to the basic Anchors Away mobile app to test over 6 weeks.

Behavioral: Anchors Away

2: Parent Enhanced Anchors Away

EXPERIMENTAL

Family will receive access to the Parent Enhanced Anchors Away mobile app to test over 6 weeks.

Behavioral: Parent Enhanced Anchors Away

3: Self-Help E-Book

ACTIVE COMPARATOR

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

4: Waitlist Control

NO INTERVENTION

Group 4 will not receive any intervention, but will be randomized into an active study arm at 6 weeks.

Interventions

Anchors Away BEHAVIORAL

Modular Cognitive Behavioral Therapy delivered through a mobile app.

1: Anchors Away

Parent Enhanced Anchors Away BEHAVIORAL

Modular Cognitive Behavioral Therapy delivered through a mobile app. Extra modules will focus specifically on parenting skills relevant to having an anxious child.

2: Parent Enhanced Anchors Away

Self-Help E-Book BEHAVIORAL

Parents will read "Helping Your Anxious Child: A Step-by-Step Guide" (Rapee, Wignall, Spence, Lyneham, \& Cobham, 2008)

3: Self-Help E-Book

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kansas City Center for Anxiety Treatment, P.A.: lead
• Virtually Better, Inc.: collaborator

Study Sites (1)

Kansas City Center for Anxiety Treatment, P.A.

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

• Margo Adams Larsen, PhD

  Virtually Better, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There is no masking in this study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: RCT with 4 arms, one being a waitlist arm that allows for re-randomization into one of the 3 "active" study arms.

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: August 31, 2017
• Study Start: August 17, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)