Clinical trial NCT03269370: Family-Focused CBT Skills App and Standard Self Help Options for Childhood Anxiety
Official title: Randomized Controlled Trial of a Family-focused CBT Skills App and Standard Self Help Options for Childhood Anxiety and Related Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Childhood Mental Disorder
Anxiety
Keywords: CBT
Self-Help
Family
Lead sponsor: Kansas City Center for Anxiety Treatment, P.A.
Sponsor class: INDUSTRY
Collaborators: name: Virtually Better, Inc.
First posted: 2017-08-31
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Spence Children's Anxiety Scale - Parent/Child Report (SCAS)
timeFrame: Entry into study, 6 weeks, 12 weeks
Secondary outcomes:
measure: DASS-21
timeFrame: Entry into study, 6 weeks, 12 weeks
measure: Centre for Epidemiological Studies- Depression Scale for Children (CES-DC)
timeFrame: Entry into study, 6 weeks, 12 weeks
measure: Anxiety Sensitivity Index- 3 (ASI-3)
timeFrame: Entry into study, 6 weeks, 12 weeks
measure: Child Anxiety Sensitivity Index (CASI)
timeFrame: Entry into study, 6 weeks, 12 weeks
measure: Behavioral Inhibition Instrument (BII)
timeFrame: Entry into study, 6 weeks, 12 weeks
measure: Treatment Status and Parent Confidence
timeFrame: Entry into study, 3 weeks, 6 weeks, 12 weeks
measure: Opinion on Intervention
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Kansas City Center for Anxiety Treatment, P.A.
state: Kansas
Study officials:
affiliation: Kansas City Center for Anxiety Treatment, P.A.
name: Kathryn D Kriegshauser, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kansas City Center for Anxiety Treatment, P.A.
name: Lisa R Hale, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virtually Better, Inc.
name: Margo Adams Larsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: