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

Not Applicable

Completed

• Conditions: Childhood Mental Disorder; Anxiety Disorders; Anxiety
• Interventions: Behavioral: Anchors Away; Behavioral: Self-Help E-Book; Behavioral: Parent Enhanced Anchors Away

• Registration Number: NCT03269370
• Lead Sponsor: Kansas City Center for Anxiety Treatment, P.A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-08-31
• Study Start: 2018-08-17
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: Anchors Away	Anchors Away	Family will receive access to the basic Anchors Away mobile app to test over 6 weeks.
3: Self-Help E-Book	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).
2: Parent Enhanced Anchors Away	Parent Enhanced Anchors Away	Family will receive access to the Parent Enhanced Anchors Away mobile app to test over 6 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Kansas City Center for Anxiety Treatment, P.A.; 🇺🇸 Overland Park, Kansas, United States