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Clinical Trials/NCT03269370
NCT03269370
Completed
N/A

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

Kansas City Center for Anxiety Treatment, P.A.1 site in 1 country110 target enrollmentAugust 17, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety Disorders
Sponsor
Kansas City Center for Anxiety Treatment, P.A.
Enrollment
110
Locations
1
Primary Endpoint
Spence Children's Anxiety Scale - Parent/Child Report (SCAS)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 17, 2018
End Date
December 31, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kansas City Center for Anxiety Treatment, P.A.
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)
  • Treatment Status and Parent Confidence(Entry into study, 3 weeks, 6 weeks, 12 weeks)
  • Opinion on Intervention(6 weeks)

Study Sites (1)

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