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

Primary Purpose

Anxiety Disorders, Childhood Mental Disorder, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anchors Away
Parent Enhanced Anchors Away
Self-Help E-Book
Sponsored by
Kansas City Center for Anxiety Treatment, P.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety Disorders focused on measuring CBT, Self-Help, Family

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kansas City Center for Anxiety Treatment, P.A.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

No Intervention

Arm Label

1: Anchors Away

2: Parent Enhanced Anchors Away

3: Self-Help E-Book

4: Waitlist Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

DASS-21
A screener for overall psychological distress of parent with sub scales assessing anxiety, depression, and stress.
Centre for Epidemiological Studies- Depression Scale for Children (CES-DC)
A 20-item screener for childhood depression and psychological distress
Anxiety Sensitivity Index- 3 (ASI-3)
A measure of parent anxiety sensitivity (fear of arousal-related sensations) in physical, social, and cognitive domains
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.
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.
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
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

Full Information

First Posted
August 29, 2017
Last Updated
August 31, 2020
Sponsor
Kansas City Center for Anxiety Treatment, P.A.
Collaborators
Virtually Better, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03269370
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 17, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kansas City Center for Anxiety Treatment, P.A.
Collaborators
Virtually Better, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Childhood Mental Disorder, Anxiety
Keywords
CBT, Self-Help, Family

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
There is no masking in this study.
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: Anchors Away
Arm Type
Experimental
Arm Description
Family will receive access to the basic Anchors Away mobile app to test over 6 weeks.
Arm Title
2: Parent Enhanced Anchors Away
Arm Type
Experimental
Arm Description
Family will receive access to the Parent Enhanced Anchors Away mobile app to test over 6 weeks.
Arm Title
3: Self-Help E-Book
Arm Type
Active Comparator
Arm Description
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).
Arm Title
4: Waitlist Control
Arm Type
No Intervention
Arm Description
Group 4 will not receive any intervention, but will be randomized into an active study arm at 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Anchors Away
Intervention Description
Modular Cognitive Behavioral Therapy delivered through a mobile app.
Intervention Type
Behavioral
Intervention Name(s)
Parent Enhanced Anchors Away
Intervention Description
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
Intervention Name(s)
Self-Help E-Book
Intervention Description
Parents will read "Helping Your Anxious Child: A Step-by-Step Guide" (Rapee, Wignall, Spence, Lyneham, & Cobham, 2008)
Primary Outcome Measure Information:
Title
Spence Children's Anxiety Scale - Parent/Child Report (SCAS)
Description
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.
Time Frame
Entry into study, 6 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
DASS-21
Description
A screener for overall psychological distress of parent with sub scales assessing anxiety, depression, and stress.
Time Frame
Entry into study, 6 weeks, 12 weeks
Title
Centre for Epidemiological Studies- Depression Scale for Children (CES-DC)
Description
A 20-item screener for childhood depression and psychological distress
Time Frame
Entry into study, 6 weeks, 12 weeks
Title
Anxiety Sensitivity Index- 3 (ASI-3)
Description
A measure of parent anxiety sensitivity (fear of arousal-related sensations) in physical, social, and cognitive domains
Time Frame
Entry into study, 6 weeks, 12 weeks
Title
Child Anxiety Sensitivity Index (CASI)
Description
A measure of sensitivity to symptoms of anxiety, similar to the ASI, measuring physical, social, and mental incapacitation concerns in children.
Time Frame
Entry into study, 6 weeks, 12 weeks
Title
Behavioral Inhibition Instrument (BII)
Description
A parent-report measure of child behavioral inhibition, which has been determined to be a risk factor for later psychopathology, particularly anxiety.
Time Frame
Entry into study, 6 weeks, 12 weeks
Title
Treatment Status and Parent Confidence
Description
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
Time Frame
Entry into study, 3 weeks, 6 weeks, 12 weeks
Title
Opinion on Intervention
Description
Self-report measure to gauge families' thoughts on user-friendliness, perceived effectiveness of intervention, and likelihood to use again or recommend to others
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn D Kriegshauser, PhD
Organizational Affiliation
Kansas City Center for Anxiety Treatment, P.A.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa R Hale, PhD
Organizational Affiliation
Kansas City Center for Anxiety Treatment, P.A.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margo Adams Larsen, PhD
Organizational Affiliation
Virtually Better, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kansas City Center for Anxiety Treatment, P.A.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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