Kidpower Camp - Structured Games or Playgroup

Neurally Targeted Interventions to Reduce Early Childhood Anxiety

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety Disorders
• Intervention / Treatment: Behavioral: Structured games; Behavioral: Playgroup

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Berenis Baez; Email: bb2145@cumc.columbia.edu
• Study Contact Backup: Name: Caroline Risdon, B.S.; Phone Number: 646-774-5868; Email: caroline.risdon@nyspi.columbia.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Completed
      • University of Michigan
    • East Lansing, Michigan, United States, 48824
      • Recruiting
      • Michigan State University
      • Contact: Jason S Moser, Ph.D.; Phone Number: 517-355-2159; Email: jmoser@msu.edu
      • Principal Investigator: Jason S Moser, Ph.D.
  • New York
    • New York, New York, United States, 10032
      • Suspended
      • New York State Psychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kidpower - Structured Games; Structured Games Camp.	Behavioral: Structured games; Camp Kidpower - Structured Games is an interactive, child-friendly "camp" and is comprised of short, game-like exercises taught by "camp counselors" to groups of approximately 4-6 children. In total, 15 different exercises will be taught. Children will attend 5 three-hour playgroup sessions over a 4-week period (twice the first week, and then only once per week for the subsequent 3-week period) to match the Playgroup intervention. Parents will be asked to attend an approximately one-hour group meeting, during which information is presented regarding child anxiety, effortful control and the rationale for this treatment. Parents are asked to continue to utilize the intervention at home every day if possible with the child and will receive texts or emails to track the games that are played at home.
Active Comparator: Kidpower - Playgroup; Playgroup camp	Behavioral: Playgroup; Camp Kidpower - Playgroup includes structured play activities. This will include art activities, dramatic play props, and a "story time". Children will attend 5 three-hour playgroup sessions over a 4-week period (twice the first week, and then only once per week for the subsequent 3-week period) to match the Kidpower intervention. During the first week parents will attend an approximately one-hour group meeting, during which information is presented regarding the positive benefits of child-led play and "special time" with caregivers. Parents well be asked to complete homework with their children during the week between sessions, and are shown how to track time spent in this activity. Parents will receive a daily text (or email) to to measure frequency of homework practice between sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Error Related Negativity (ERN)	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.	Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)
Change in National Institutes of Health (NIH) Toolbox Effortful Control (EC) Composite Scale	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.	Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)
Change in Clinical Global Impressions -Severity and Improvement Scales	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.	Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anxiety Disorders Interview Schedule - Parent Version (ADIS-P)	ADIS-P is a semi-structured clinical interview administered to parents 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.	Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)
Change in Spence Preschool Anxiety Scale (Spence PAS)	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.	Pre-treatment (baseline) up to post-treatment assessments (approximately 4-6 weeks)

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Mental Health (NIMH); University of Maryland; University of Michigan; Michigan State University
• Investigators: Principal Investigator: Kate D Fitzgerald, M.D., Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Preschool; Effortful Control; Error-related negativity
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 8263; 1R33MH121641-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No