ClinicalTrials.gg
CompletedNCT03269370Updated Sep 2, 2020

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

An interventional study of Anchors Away and Parent Enhanced Anchors Away in Anxiety Disorders, Childhood Mental Disorder and Anxiety, sponsored by Kansas City Center for Anxiety Treatment, P.A.. Completed at 1 site in United States. Open to participants aged 6 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-02.

Sponsored by Kansas City Center for Anxiety Treatment, P.A. · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
6 Years to 11 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 2,266 studies in Anxiety Disorders with a site in United States — 397 open to participants now, 504 under way, 13 of them phase 3. Anxiety Disorders · United States.

Enrollment
691st of 2,042
110 · median 69
Started
2018
with 119 others
No phase
1,607 of 2,266
294 open now
Registered
822nd of 2,266
by date

Among the 2,266 studies in Anxiety Disorders with a site in United States, this one is the 691st largest by enrollment of the 2,042 interventional ones, is one of 120 that started in 2018, is one of 1,607 with no phase, and was the 822nd registered.

By phase

2,266 studies; the count open now beside each. This study's row is marked.

No phasethis study1,607 · 294 open
Observational215 · 38 open
Phase 2142 · 33 open
Phase 488 · 10 open
Phase 182 · 10 open
Phase 374 · 7 open
Phase 1/237 · 4 open
Phase 2/321 · 1 open

By the year they started

First in 1983; this study’s year is marked. 120 started in 2018.

Size and results

Median enrollment 69 across the 2,042 interventional studies, 156 across the 215 observational. Of the 1,595 that completed or were terminated, 502 (31%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 2,266 studies in Anxiety Disorders with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Anxiety Disorders
  • Childhood Mental Disorder
  • Anxiety

Keywords

  • CBT
  • Self-Help
  • Family
04

Who can participate

Ages eligible
6 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    1: Anchors Away

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

    Behavioral: Anchors Away

  • Experimental
    2: Parent Enhanced Anchors Away

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

    Behavioral: Parent Enhanced Anchors Away

  • Active comparator
    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).

    Behavioral: Self-Help E-Book

  • No intervention
    4: Waitlist Control

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

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)

06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. DASS-21

    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

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

    A 20-item screener for childhood depression and psychological distress

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

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

    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

  4. 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.

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

  5. 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.

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

  6. 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

    Time frame: Entry into study, 3 weeks, 6 weeks, 12 weeks

  7. 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

    Time frame: 6 weeks

07

Study locations

1 site
  • Kansas City Center for Anxiety Treatment, P.A.
    Overland Park, Kansas 66212, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2018 to primary completion in Dec 2019, 16 months.

Of 102 industry-sponsored interventional studies with no phase under Anxiety Disorders, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's 16 months is above that.

Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2017
First posted
Aug 31, 2017
StartActual
Aug 17, 2018
Primary completionActual
Dec 31, 2019
CompletionActual
Dec 31, 2019
Last update
Sep 2, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03269370
Lead sponsor
Kansas City Center for Anxiety Treatment, P.A.
Collaborators
Virtually Better, Inc.
Responsible party
Sponsor
First posted
Aug 31, 2017
Start date
Aug 17, 2018
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Sep 2, 2020

Study contacts

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.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion