Kidpower Camp - Structured Games or Playgroup

NCT04960813 | Completed Results DMC

• 3 other identifiers: AAAU84421R33MH121641-01A1NYSPI 8263
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 4

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.

Conditions

Anxiety Disorders

Keywords

Effortful Control; Preschool; Error-related negativity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

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

  Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)

• Change in Spence Preschool Anxiety Scale (Spence PAS)

  Pre-treatment (baseline) up to post-treatment assessments (approximately 4-6 weeks)

Study Arms (2)

Kidpower - Structured Games

EXPERIMENTAL

Structured Games Camp.

Behavioral: Structured games

Kidpower - Playgroup

ACTIVE COMPARATOR

Playgroup camp

Behavioral: Playgroup

Interventions

Structured games BEHAVIORAL

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.

Kidpower - Structured Games

Playgroup BEHAVIORAL

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.

Kidpower - Playgroup

Eligibility Criteria

• Age: 48 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Mental Health (NIMH): collaborator
• Michigan State University: collaborator
• University of Michigan: collaborator
• University of Maryland: collaborator

Study Sites (4)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Columbia University

New York, New York, 10019, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Kate D. Fitzgerald
• Organization: Columbia University

kf2688@cumc.columbia.edu

646-774-5681

Study Officials

• Kate D Fitzgerald, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The rater will be blinded to which intervention, structured games or playgroup, child participants receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ruane Professor of Child and Adolescent Psychiatry

Model Details: Children will be randomized 1:1 to structured games or a playgroup. The structured games and playgroup will run in parallel.

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 14, 2021
• Study Start: July 7, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: April 30, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)