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

Study 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.

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

Conditions
-----------------
Anxiety, Anxiety Disorders, Childhood Mental Disorder

Intervention / Treatment
-----------------
* Behavioral: Anchors Away
* Behavioral: Parent Enhanced Anchors Away
* Behavioral: Self-Help E-Book


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: Anchors Away<br>Family will receive access to the basic Anchors Away mobile app to test over 6 weeks. | Behavioral: Anchors Away<br>* Modular Cognitive Behavioral Therapy delivered through a mobile app.<br>|
| Experimental: 2: Parent Enhanced Anchors Away<br>Family will receive access to the Parent Enhanced Anchors Away mobile app to test over 6 weeks. | Behavioral: Parent Enhanced Anchors Away<br>* Modular Cognitive Behavioral Therapy delivered through a mobile app. Extra modules will focus specifically on parenting skills relevant to having an anxious child.<br>|
| Active Comparator: 3: Self-Help E-Book<br>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<br>* Parents will read Helping Your Anxious Child: A Step-by-Step Guide (Rapee, Wignall, Spence, Lyneham, & Cobham, 2008)<br>|
| No Intervention: 4: Waitlist Control<br>Group 4 will not receive any intervention, but will be randomized into an active study arm at 6 weeks. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CBT, Self-Help, Family