Clinical trial NCT04960813: Kidpower Camp - Structured Games or Playgroup
Official title: Neurally Targeted Interventions to Reduce Early Childhood Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: Effortful Control
Preschool
Error-related negativity
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Michigan State University
name: University of Michigan
name: University of Maryland
First posted: 2021-07-14
Enrollment: 158
Sex: ALL
Minimum age (years): 48
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children will be randomized 1:1 to structured games or a playgroup. The structured games and playgroup will run in parallel.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Error Related Negativity (ERN)
timeFrame: Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)
measure: Change in National Institutes of Health (NIH) Toolbox Effortful Control (EC) Composite Scale
timeFrame: Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)
measure: Change in Clinical Global Impressions -Severity and Improvement Scales
timeFrame: Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)
Secondary outcomes:
measure: Change in Anxiety Disorders Interview Schedule - Parent Version (ADIS-P)
timeFrame: Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)
measure: Change in Spence Preschool Anxiety Scale (Spence PAS)
timeFrame: Pre-treatment (baseline) up to post-treatment assessments (approximately 4-6 weeks)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Columbia University
name: Kate D Fitzgerald, M.D.
role: PRINCIPAL_INVESTIGATOR
References: