Kidpower Camp - Structured Games or Playgroup

Not Applicable

Completed

Conditions: Anxiety Disorders

Interventions: Behavioral: Playgroup
Behavioral: Structured games

Registration Number: NCT04960813

Lead Sponsor: Columbia University

Brief Summary: Clinically significant anxiety affects 20% of preschoolers and can become chronic, leading to depression, substance abuse, school-drop out and even suicide. To reduce anxiety and prevent its sequelae, clinically affected children must be effectively treated early. Available interventions for clinically anxious preschoolers are effective for some, but not all children, with as many as 50% of 4-7 year olds continuing to meet criteria for an anxiety disorder after treatment.

This trial aims to help learn how Camp Kidpower, trainings using either structured games or a playgroup, may lower anxiety in preschool age children. Playing these games and learning that kids can do it, can teach kids how to keep going when they are feeling anxious. To find out if Kidpower works by helping kids stay in charge of their behaviors and emotions, the study will look at parts of the brain as well as behaviors related to effortful control and fear, before and after training.

The study hypothesizes that Kidpower will produce greater increases in Error-related negativity (ERN), Interchannel Phase Synchrony (ICPS) and effortful control (EC) behaviors than in the Playgroup control.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 158

Inclusion Criteria

Children between ages 4 -5.99 years at time of consent
Children that have a primary clinical diagnosis of separation anxiety disorder, social anxiety disorder, generalized anxiety disorder, panic disorder, and/or obsessive-compulsive disorder
Written informed consent by a parent/legal guardian and verbal assent from participant
Fluent in English

Exclusion Criteria

History of head injury
History of serious medical or neurological illness
History of post-traumatic stress disorder (PTSD)
History of major depressive disorder (MDD)
Current psychotherapy or behavioral interventions
History of Neurodevelopmental delay, autism spectrum disorder (ASD), or intellectual disability
Currently taking medications that affect central nervous system functioning
Primary clinical diagnosis is selective mutism or specific phobia
Recent history of physically aggressive behaviors that have caused harm to other children
Sibling of a child who has participated or is currently participating in this protocol

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kidpower - Playgroup	Playgroup	Playgroup camp
Kidpower - Structured Games	Structured games	Structured Games Camp.

Primary Outcome Measures

Name	Time	Method
Change in Error Related Negativity (ERN)	Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)	The error-related negativity is a neurophysiological signal, measured via electroencephalogram (EEG), considered to reflect a dorsal anterior cingulate cortex (ACC) response to errors. For this study the ERN will be measured at electrode site FCz as the downward (negative voltage) deflection of the EEG signal that occurs 50-100 msec after error commission on the Zoo Task. Scores are measured continuously (no established minimum or maximum) . Higher scores reflect greater neural capacity for effortful control.
Change in National Institutes of Health (NIH) Toolbox Effortful Control (EC) Composite Scale	Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)	The NIH Toolbox EC Composite Scale will be comprised of children's standardized scores reflecting accuracy and reaction time on two computerized tasks: the Flanker inhibitory control and attention task and the Dimensional Change Card Sort (DCCS) test of set-shifting function. An NIH Toolbox EC Composite score will be based on factor loadings for each task derived from a factor analysis of scores across both Toolbox tasks. Scores are measured continuously (no established minimum or maximum) . Higher scores reflect greater behavioral capacity for effortful control.
Change in Clinical Global Impressions -Severity and Improvement Scales	Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)	The Clinical Global Impressions (CGI) is an observer rated scale used to assess anxiety severity (CGI-S) and pre- to post-treatment improvement in anxiety (CGI-I). Ratings for both use a 7-point scale, from 1 "normal" to 7 "among the most severely ill" for CGI-S and 1 ("very much improved") to 7 ("very much worse") for CGI-I.

Secondary Outcome Measures

Name	Time	Method
Change in Anxiety Disorders Interview Schedule - Parent Version (ADIS-P)	Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)	ADIS-P is a semi-structured clinical interview administered to parents about their child to assess Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnoses where anxiety is a component. Severity of symptoms is rated by interviewers on a scale from none (=0) to very severe (=8), with clinician severity rating (CSR) ≥ 4 indicating presence of diagnosis. Changes in CSR of the primary (i.e., most severe at baseline) anxiety diagnosis from pre to post intervention will be assessed.
Change in Spence Preschool Anxiety Scale (Spence PAS)	Pre-treatment (baseline) up to post-treatment assessments (approximately 4-6 weeks)	The Spence PAS is a validated instrument for the measurement of parent report of anxiety symptoms in young children. Spence PAS scores will provide a continuous rating of anxiety symptoms from 0 to 112; high scores reflect greater anxiety.

Trial Locations

Locations (4): University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
Michigan State University
🇺🇸
East Lansing, Michigan, United States
Columbia University
🇺🇸
New York, New York, United States
New York State Psychiatric Institute
🇺🇸
New York, New York, United States