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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My child is between 4 and 5.99 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Change in Anxiety Disorders Interview Schedule - Parent Version (ADIS-P)

Change in Spence Preschool Anxiety Scale (Spence PAS)

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganOTHER

1,797 Previous Clinical Trials

6,377,968 Total Patients Enrolled

14 Trials studying Anxiety Disorders

7,985 Patients Enrolled for Anxiety Disorders

University of MarylandOTHER

160 Previous Clinical Trials

302,193 Total Patients Enrolled

3 Trials studying Anxiety Disorders

2,641 Patients Enrolled for Anxiety Disorders

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,447,169 Total Patients Enrolled

8 Trials studying Anxiety Disorders

13,324 Patients Enrolled for Anxiety Disorders

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications must be met to participate in this experiment?

"This study seeks to include 90 infants and toddlers, ranging between 48-71 months of age, who are exhibiting signs of anxiety. All participants must be within 4 - 5.99 years old with subclinical or clinical levels of anxiousness."

Answered by AI

Are there still slots open for enrollment in this experiment?

"Indeed, data posted on clinicaltrials.gov affirms that this health experiment is actively recruiting patients and has been since July 7th 2021. Requiring 90 participants across two sites, the study was last updated as recently as December 22nd 2021."

Answered by AI

How many individuals are currently participating in this clinical trial?

"Affirmative. According to information provided on clinicaltrials.gov, this medical trial began recruiting patients on July 7th 2021 and was recently updated on December 22nd of the same year. The research team is looking for 90 participants from two different sites."

Answered by AI