Kidpower Camp - Structured Games or Playgroup

Columbia University

Status: Completed

Conditions: Anxiety Disorders

Treatments: Behavioral: Playgroup; Behavioral: Structured games

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04960813

NYSPI 8263 (Other Identifier)

AAAU8442

1R33MH121641-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 158 patients

Sex: All

Ages: 48 to 71 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

Kidpower - Structured Games

Experimental group

Description:

Structured Games Camp.

Treatment:

Behavioral: Structured games

Kidpower - Playgroup

Active Comparator group

Description:

Playgroup camp

Treatment:

Behavioral: Playgroup