Anxiety DisordersNCT03269370

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

A study testing Anchors Away, Parent Enhanced Anchors Away and Self-Help E-Book in people with Anxiety Disorders and Childhood Mental Disorder, run by Kansas City Center for Anxiety Treatment, P.A. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 to 11 yearsHealthy volunteers can take part
Conditions the study is for: Anxiety Disorders, Childhood Mental Disorder, Anxiety
What is being tested?: Anchors Away, Parent Enhanced Anchors Away and Self-Help E-Book
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteUnited States
Study dates: 17 Aug 2018to 31 Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 11 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Availability of mobile technology (e.g., smart phone, tablet)
Internet access
English language spoken in the home

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Kansas City Center for Anxiety Treatment, P.A.
Overland Park, Kansas, 66212

Other trials in United States

About this study

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

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.

Conditions: Anxiety Disorders, Childhood Mental Disorder, Anxiety
Being tested: Anchors Away, Parent Enhanced Anchors Away, Self-Help E-Book
Keywords: CBT, Self-Help, Family
Medical subject headings: Anxiety Disorders, Neurodevelopmental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anchors AwayBehavioural
Modular Cognitive Behavioral Therapy delivered through a mobile app.
Parent Enhanced Anchors AwayBehavioural
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-BookBehavioural
Parents will read "Helping Your Anxious Child: A Step-by-Step Guide" (Rapee, Wignall, Spence, Lyneham, \& Cobham, 2008)

Study groups in NCT03269370
Study group	Role	What they receive
1: Anchors Away	Experimental	Family will receive access to the basic Anchors Away mobile app to test over 6 weeks. Receives: Behavioral: Anchors Away
2: Parent Enhanced Anchors Away	Experimental	Family will receive access to the Parent Enhanced Anchors Away mobile app to test over 6 weeks. Receives: Behavioral: Parent Enhanced Anchors Away
3: Self-Help E-Book	Active comparator	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). Receives: Behavioral: Self-Help E-Book
4: Waitlist Control	No intervention	Group 4 will not receive any intervention, but will be randomized into an active study arm at 6 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Entry into study, 6 weeks, 12 weeks

Secondary outcomes (7)

DASS-21
A screener for overall psychological distress of parent with sub scales assessing anxiety, depression, and stress.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Aug 201831 Dec 2019

First posted31 Aug 2017
Study start17 Aug 2018
Primary completion31 Dec 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Anxiety DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03269370
Sponsor's protocol ID: 2R44MH098470-03
Status last verified: Aug 2020
First submitted: 29 Aug 2017
Last updated: 2 Sep 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial of a Family-focused CBT Skills App and Standard Self Help Options for Childhood Anxiety and Related Conditions
ClinicalTrials.gov ID: NCT03269370
Acronym / sponsor ID: 2R44MH098470-03
Conditions: Anxiety Disorders, Childhood Mental Disorder, Anxiety
Keywords: CBT, Self-Help, Family
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Kansas City Center for Anxiety Treatment, P.A.Industry (pharma, biotech, devices)
Collaborators: Virtually Better, Inc.
Study start: 17 Aug 2018 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 31 Aug 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: RCT with 4 arms, one being a waitlist arm that allows for re-randomization into one of the 3 "active" study arms.

Arm	Type	Receives
1: Anchors Away	Experimental	Behavioral: Anchors AwayFamily will receive access to the basic Anchors Away mobile app to test over 6 weeks.
2: Parent Enhanced Anchors Away	Experimental	Behavioral: Parent Enhanced Anchors AwayFamily will receive access to the Parent Enhanced Anchors Away mobile app to test over 6 weeks.
3: Self-Help E-Book	Active comparator	Behavioral: Self-Help E-BookGroup 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).
4: Waitlist Control	No intervention	–Group 4 will not receive any intervention, but will be randomized into an active study arm at 6 weeks.

Who may qualify

Ages: 6 to 11 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Availability of mobile technology (e.g., smart phone, tablet)
Internet access
English language spoken in the home

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Anchors AwayModular Cognitive Behavioral Therapy delivered through a mobile app.	Behavioural	1: Anchors Away
Parent Enhanced Anchors AwayModular Cognitive Behavioral Therapy delivered through a mobile app. Extra modules will focus specifically on parenting skills relevant to having an anxious child.	Behavioural	2: Parent Enhanced Anchors Away
Self-Help E-BookParents will read "Helping Your Anxious Child: A Step-by-Step Guide" (Rapee, Wignall, Spence, Lyneham, \& Cobham, 2008)	Behavioural	3: Self-Help E-Book

Primary outcome

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.

7 secondary outcomes

DASS-21
Time frame: Entry into study, 6 weeks, 12 weeks
Centre for Epidemiological Studies- Depression Scale for Children (CES-DC)
Time frame: Entry into study, 6 weeks, 12 weeks
Anxiety Sensitivity Index- 3 (ASI-3)
Time frame: Entry into study, 6 weeks, 12 weeks
Child Anxiety Sensitivity Index (CASI)
Time frame: Entry into study, 6 weeks, 12 weeks
Behavioral Inhibition Instrument (BII)
Time frame: Entry into study, 6 weeks, 12 weeks
Treatment Status and Parent Confidence
Time frame: Entry into study, 3 weeks, 6 weeks, 12 weeks
Opinion on Intervention
Time frame: 6 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kathryn D Kriegshauser, PhD principal investigator

Kansas City Center for Anxiety Treatment, P.A.

Lisa R Hale, PhD principal investigator

Kansas City Center for Anxiety Treatment, P.A.

Margo Adams Larsen, PhD principal investigator

Virtually Better, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spence Children's Anxiety Scale - Parent/Child Report (SCAS) (time frame: Entry into study, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03269370.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.