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Completed

NCT Number: NCT03269370

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

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.

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Key information

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kansas City Center for Anxiety Treatment, P.A.

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anchors Away

Behavioral

Modular Cognitive Behavioral Therapy delivered through a mobile app.

Parent Enhanced Anchors Away

Behavioral

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

Behavioral

Parents will read "Helping Your Anxious Child: A Step-by-Step Guide" (Rapee, Wignall, Spence, Lyneham, & Cobham, 2008)

Primary outcomes

  1. 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

  1. DASS-21

    Time frame: Entry into study, 6 weeks, 12 weeks

    A screener for overall psychological distress of parent with sub scales assessing anxiety, depression, and stress.

  2. Centre for Epidemiological Studies- Depression Scale for Children (CES-DC)

    Time frame: Entry into study, 6 weeks, 12 weeks

    A 20-item screener for childhood depression and psychological distress

  3. Anxiety Sensitivity Index- 3 (ASI-3)

    Time frame: Entry into study, 6 weeks, 12 weeks

    A measure of parent anxiety sensitivity (fear of arousal-related sensations) in physical, social, and cognitive domains

  4. Child Anxiety Sensitivity Index (CASI)

    Time frame: 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.

  5. Behavioral Inhibition Instrument (BII)

    Time frame: 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.

  6. Treatment Status and Parent Confidence

    Time frame: 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

  7. Opinion on Intervention

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kansas City Center for Anxiety Treatment, P.A.

Industry

Collaborators

  • Virtually Better, Inc.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 31, 2017
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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