Adults 48 Months to 71 Months, any sex, with Anxiety Disorders. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Error Related Negativity (ERN)Primary· Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)
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.
Group
Value
95% CI
Kidpower - Structured Games
-0.169
± 8.129
Kidpower - Playgroup
-1.192
± 10.194
Change in National Institutes of Health (NIH) Toolbox Effortful Control (EC) Composite ScalePrimary· Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)
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.
Group
Value
95% CI
Kidpower - Structured Games
.3265
± .628
Kidpower - Playgroup
.406
± .5655
Change in Clinical Global Impressions -Severity and Improvement ScalesPrimary· Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)
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.
CGI-S
Group
Value
95% CI
Kidpower - Structured Games
1.16
± 0.93
Kidpower - Playgroup
1.14
± 0.98
CGI-I
Group
Value
95% CI
Kidpower - Structured Games
2.44
± 0.76
Kidpower - Playgroup
2.67
± 0.87
Change in Anxiety Disorders Interview Schedule - Parent Version (ADIS-P)Secondary· Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)
ADIS-P is a semi-structured clinical interview administered to parents about their child 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.
Group
Value
95% CI
Kidpower - Structured Games
2.04
± 1.56
Kidpower - Playgroup
1.94
± 1.91
Change in Spence Preschool Anxiety Scale (Spence PAS)Secondary· Pre-treatment (baseline) up to post-treatment assessments (approximately 4-6 weeks)
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.
Group
Value
95% CI
Kidpower - Structured Games
-10.4
± 11.4
Kidpower - Playgroup
-6.05
± 14.9
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Columbia University
Last refreshed: 30 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04960813.