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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 belowSelect...
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:Select...
I am currently undergoing psychotherapy or behavioral interventions.
Select...
I am on medication that affects my brain function.
Select...
My diagnosis is either selective mutism or specific phobia.
Select...
I have been diagnosed with major depressive disorder.
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)
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
1,854 Previous Clinical Trials
6,433,471 Total Patients Enrolled
15 Trials studying Anxiety Disorders
8,095 Patients Enrolled for Anxiety Disorders
University of MarylandOTHER
168 Previous Clinical Trials
304,851 Total Patients Enrolled
3 Trials studying Anxiety Disorders
2,641 Patients Enrolled for Anxiety Disorders
Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,663,100 Total Patients Enrolled
8 Trials studying Anxiety Disorders
13,329 Patients Enrolled for Anxiety Disorders
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of serious illness.I am currently undergoing psychotherapy or behavioral interventions.I am on medication that affects my brain function.My diagnosis is either selective mutism or specific phobia.My child has been diagnosed with an anxiety or obsessive-compulsive disorder.I have been diagnosed with major depressive disorder.My child is between 4 and 5.99 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Kidpower - Playgroup
- Group 2: Kidpower - Structured Games
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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