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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-17

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Investigating the Effects of Parent Component to Cognitive Behavior Therapy (CBT) for Youth With Anxiety Disorders

NCT02160444

Anxiety Disorders

UNKNOWN NA

Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings

NCT02350257

Anxiety Disorders

COMPLETED NA

Brief Cognitive Behavioral Therapy (CBT) for Pediatric Anxiety and Depression in Primary Care

NCT01147614

Anxiety Depression

COMPLETED NA

Family and Peer Involvement in the Treatment of Anxiety Disorders in Children

NCT00073645

Anxiety Disorders

COMPLETED PHASE1

Clinical and Cost Effectiveness of Brief Cognitive-Behavioral Therapy (CBT) for Pediatric Internalizing Disorders

NCT00669526

Depression Anxiety

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Disorders Childhood Mental Disorder Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT with 4 arms, one being a waitlist arm that allows for re-randomization into one of the 3 "active" study arms.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

There is no masking in this study.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1: Anchors Away

Family will receive access to the basic Anchors Away mobile app to test over 6 weeks.

Group Type EXPERIMENTAL

Anchors Away

Intervention Type BEHAVIORAL

Modular Cognitive Behavioral Therapy delivered through a mobile app.

2: Parent Enhanced Anchors Away

Family will receive access to the Parent Enhanced Anchors Away mobile app to test over 6 weeks.

Group Type EXPERIMENTAL

Parent Enhanced Anchors Away

Intervention Type BEHAVIORAL

Modular Cognitive Behavioral Therapy delivered through a mobile app. Extra modules will focus specifically on parenting skills relevant to having an anxious child.

3: Self-Help E-Book

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).

Group Type ACTIVE_COMPARATOR

Self-Help E-Book

Intervention Type BEHAVIORAL

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

4: Waitlist Control

Group 4 will not receive any intervention, but will be randomized into an active study arm at 6 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anchors Away

Modular Cognitive Behavioral Therapy delivered through a mobile app.

Intervention Type BEHAVIORAL

Parent 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.

Intervention Type BEHAVIORAL

Self-Help E-Book

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes