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Structured Games/Playgroup for Childhood Anxiety

N/A
Recruiting
Led By Kate Fitzgerald, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children between ages 4 -5.99 years at time of consent
Be younger than 18 years old
Must not have
Current psychotherapy or behavioral interventions
Currently taking medications that affect central nervous system functioning
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if the Camp Kidpower training, which uses either structured games or a playgroup, can lower anxiety in preschool age children. The study will look at parts of the brain as well as behaviors related to effortful control and fear, before and after training, to see if Kidpower helps kids stay in charge of their behaviors and emotions.

Who is the study for?
This trial is for English-speaking children aged 4 to nearly 6 with anxiety disorders like separation, social, or generalized anxiety. Kids must not be in current therapy, have a history of serious mental conditions like autism or depression, head injuries, aggressive behavior causing harm, or be on certain medications.
What is being tested?
The Kidpower Camp aims to reduce anxiety in preschoolers through structured games or playgroup activities. It will measure changes in brain function and behaviors related to controlling emotions and actions before and after the program to see if it helps kids manage their anxiety better than regular playgroups.
What are the potential side effects?
Since this trial involves behavioral interventions rather than medication, traditional side effects are not applicable. However, there may be emotional responses such as frustration or increased anxiety during participation that will be monitored by professionals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child is between 4 and 5.99 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently undergoing psychotherapy or behavioral interventions.
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I am on medication that affects my brain function.
Select...
My diagnosis is either selective mutism or specific phobia.
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I have been diagnosed with major depressive disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Clinical Global Impressions -Severity and Improvement Scales
Change in Error Related Negativity (ERN)
Change in National Institutes of Health (NIH) Toolbox Effortful Control (EC) Composite Scale
Secondary study objectives
Change in Anxiety Disorders Interview Schedule - Parent Version (ADIS-P)
Change in Spence Preschool Anxiety Scale (Spence PAS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Kidpower - Structured GamesExperimental Treatment1 Intervention
Structured Games Camp.
Group II: Kidpower - PlaygroupActive Control1 Intervention
Playgroup camp

Find a Location

Who is running the clinical trial?

University of MichiganOTHER
1,863 Previous Clinical Trials
6,441,483 Total Patients Enrolled
16 Trials studying Anxiety Disorders
8,120 Patients Enrolled for Anxiety Disorders
University of MarylandOTHER
169 Previous Clinical Trials
306,851 Total Patients Enrolled
3 Trials studying Anxiety Disorders
2,641 Patients Enrolled for Anxiety Disorders
Columbia UniversityLead Sponsor
1,498 Previous Clinical Trials
2,767,035 Total Patients Enrolled
8 Trials studying Anxiety Disorders
13,329 Patients Enrolled for Anxiety Disorders
National Institute of Mental Health (NIMH)NIH
2,933 Previous Clinical Trials
2,741,388 Total Patients Enrolled
165 Trials studying Anxiety Disorders
69,076 Patients Enrolled for Anxiety Disorders
Michigan State UniversityOTHER
198 Previous Clinical Trials
685,665 Total Patients Enrolled
3 Trials studying Anxiety Disorders
401 Patients Enrolled for Anxiety Disorders
Kate Fitzgerald, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
206 Total Patients Enrolled
Kate Rosenblum, PhDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
48 Total Patients Enrolled
1 Trials studying Anxiety Disorders
48 Patients Enrolled for Anxiety Disorders
Kate D Fitzgerald, M.D.Principal InvestigatorColumbia University

Media Library

Playgroup Clinical Trial Eligibility Overview. Trial Name: NCT04960813 — N/A
Anxiety Disorders Research Study Groups: Kidpower - Playgroup, Kidpower - Structured Games
Anxiety Disorders Clinical Trial 2023: Playgroup Highlights & Side Effects. Trial Name: NCT04960813 — N/A
Playgroup 2023 Treatment Timeline for Medical Study. Trial Name: NCT04960813 — N/A
~10 spots leftby Jun 2025
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