Kidpower Camp - Structured Games or Playgroup

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

Interventions

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.

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Michigan State University

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• Columbia University

  lead OTHER

Principal Investigators

• Kate D Fitzgerald, M.D. · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

48 Months

Max Age

71 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-07

Primary Completion

2024-03-01

Completion

2024-03-01

Countries

• United States

Study Locations