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

Sponsor

Kansas City Center for Anxiety Treatment, P.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT03269370

Collaborator

Virtually Better, Inc. (Industry)

110

Enrollment

Location

Arms

16.5

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders Childhood Mental Disorder Anxiety	Behavioral: Anchors Away Behavioral: Parent Enhanced Anchors Away Behavioral: Self-Help E-Book	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Masking Description:

There is no masking in this study.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 17, 2018

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

DASS-21 [Entry into study, 6 weeks, 12 weeks]
A screener for overall psychological distress of parent with sub scales assessing anxiety, depression, and stress.
Centre for Epidemiological Studies- Depression Scale for Children (CES-DC) [Entry into study, 6 weeks, 12 weeks]
A 20-item screener for childhood depression and psychological distress
Anxiety Sensitivity Index- 3 (ASI-3) [Entry into study, 6 weeks, 12 weeks]
A measure of parent anxiety sensitivity (fear of arousal-related sensations) in physical, social, and cognitive domains
Child Anxiety Sensitivity Index (CASI) [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.
Behavioral Inhibition Instrument (BII) [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.
Treatment Status and Parent Confidence [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
Opinion on Intervention [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kansas City Center for Anxiety Treatment, P.A.	Overland Park	Kansas	United States	66212

Sponsors and Collaborators

Kansas City Center for Anxiety Treatment, P.A.
Virtually Better, Inc.

Investigators

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.
Principal Investigator: Margo Adams Larsen, PhD, Virtually Better, Inc.