Anxiety, Anxiety Disorders, Childhood Mental Disorder
Conditions
Keywords
CBT, Self-Help, Family
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.
Interventions
BEHAVIORALAnchors Away
Modular Cognitive Behavioral Therapy delivered through a mobile app.
BEHAVIORALParent 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.
BEHAVIORALSelf-Help E-Book
Parents will read Helping Your Anxious Child: A Step-by-Step Guide (Rapee, Wignall, Spence, Lyneham, & Cobham, 2008)
Sponsors
Virtually Better, Inc.
Kansas City Center for Anxiety Treatment, P.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
There is no masking in this study.
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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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. |
Countries
United States
Outcome results
None listed