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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03269370
• Other study ID #: 2R44MH098470-03
• Status: Completed
• Phase: N/A
• Start date: August 17, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2020
• Source: Kansas City Center for Anxiety Treatment, P.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Childhood Mental Disorder
• Disease
• Mental Disorders

Intervention

Behavioral:
• Anchors Away
Modular Cognitive Behavioral Therapy delivered through a mobile app.
• 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.
• Self-Help E-Book
Parents will read "Helping Your Anxious Child: A Step-by-Step Guide" (Rapee, Wignall, Spence, Lyneham, & Cobham, 2008)

Locations

Country	Name	City	State
United States	Kansas City Center for Anxiety Treatment, P.A.	Overland Park	Kansas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

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