Trial Outcomes & Findings for Kidpower Camp - Structured Games or Playgroup (NCT NCT04960813)

Last Updated: 2025-04-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

158 participants

Primary outcome timeframe

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

Results posted on

2025-04-30

Participant Flow

The numbers in the Participant Flow represent individual participants.

Participants complete a clinical assessment that determines eligibility. Of the 158 participants, 26 were ineligible from assessment, and 22 withdrew or were not responsive, leaving 110 randomized to treatment.

Participant milestones

Participant milestones
Measure	Kidpower - Structured Games Structured Games Camp. 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.	Kidpower - Playgroup Playgroup camp 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.
Overall Study STARTED	57	53
Overall Study COMPLETED	49	44
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

We could not retrieve the ages of 4 participants due to destroyed paperwork for de-identification purposes.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Kidpower - Structured Games n=57 Participants Structured Games Camp. 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.	Kidpower - Playgroup n=53 Participants Playgroup camp 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.	Total n=110 Participants Total of all reporting groups
Age, Continuous	4.45 years STANDARD_DEVIATION 0.50 • n=56 Participants • We could not retrieve the ages of 4 participants due to destroyed paperwork for de-identification purposes.	4.46 years STANDARD_DEVIATION 0.54 • n=50 Participants • We could not retrieve the ages of 4 participants due to destroyed paperwork for de-identification purposes.	4.45 years STANDARD_DEVIATION 0.52 • n=106 Participants • We could not retrieve the ages of 4 participants due to destroyed paperwork for de-identification purposes.
Sex: Female, Male Female	40 Participants n=57 Participants	21 Participants n=53 Participants	61 Participants n=110 Participants
Sex: Female, Male Male	17 Participants n=57 Participants	32 Participants n=53 Participants	49 Participants n=110 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=57 Participants	11 Participants n=53 Participants	21 Participants n=110 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=57 Participants	39 Participants n=53 Participants	85 Participants n=110 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=57 Participants	3 Participants n=53 Participants	4 Participants n=110 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=57 Participants	0 Participants n=53 Participants	0 Participants n=110 Participants
Race (NIH/OMB) Asian	4 Participants n=57 Participants	3 Participants n=53 Participants	7 Participants n=110 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=57 Participants	2 Participants n=53 Participants	2 Participants n=110 Participants
Race (NIH/OMB) Black or African American	2 Participants n=57 Participants	5 Participants n=53 Participants	7 Participants n=110 Participants
Race (NIH/OMB) White	33 Participants n=57 Participants	30 Participants n=53 Participants	63 Participants n=110 Participants
Race (NIH/OMB) More than one race	15 Participants n=57 Participants	9 Participants n=53 Participants	24 Participants n=110 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=57 Participants	4 Participants n=53 Participants	7 Participants n=110 Participants
Region of Enrollment United States	57 Participants n=57 Participants	53 Participants n=53 Participants	110 Participants n=110 Participants

PRIMARY outcome

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

Population: 18 participants from structured games and 12 participants from playgroup did not complete pre or post camp EEG or did not yield usable EEG data.

Outcome measures

Outcome measures
Measure	Kidpower - Structured Games n=31 Participants Structured Games Camp. 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.	Kidpower - Playgroup n=32 Participants Playgroup camp 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.
Change in Error Related Negativity (ERN)	-0.169 millivolts Standard Deviation 8.129	-1.192 millivolts Standard Deviation 10.194

PRIMARY outcome

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

Population: 5 participants from structured games and 1 participant from playgroup did not complete the NIH toolbox or did not yield usable data at pre and/or post camp visits.

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.

Outcome measures

Outcome measures
Measure	Kidpower - Structured Games n=44 Participants Structured Games Camp. 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.	Kidpower - Playgroup n=43 Participants Playgroup camp 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.
Change in National Institutes of Health (NIH) Toolbox Effortful Control (EC) Composite Scale	.3265 score on a scale Standard Deviation .628	.406 score on a scale Standard Deviation .5655

PRIMARY outcome

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

Population: Of the 93 completers, 2 participants did not complete the post-camp CGI-S/I. An additional 4 CGI-S/I were unavailable for analysis, leaving 87 CGI-S/I for the final analysis population.

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.

Outcome measures

Outcome measures
Measure	Kidpower - Structured Games n=45 Participants Structured Games Camp. 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.	Kidpower - Playgroup n=42 Participants Playgroup camp 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.
Change in Clinical Global Impressions -Severity and Improvement Scales CGI-S	1.16 score on a scale Standard Deviation 0.93	1.14 score on a scale Standard Deviation 0.98
Change in Clinical Global Impressions -Severity and Improvement Scales CGI-I	2.44 score on a scale Standard Deviation 0.76	2.67 score on a scale Standard Deviation 0.87

SECONDARY outcome

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

Population: Of the 93 completers, 2 participants did not complete the post-camp ADIS. An additional 4 ADIS CSR were unavailable for analysis, leaving 87 ADIS CSR for the final analysis population.

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.

Outcome measures

Outcome measures
Measure	Kidpower - Structured Games n=45 Participants Structured Games Camp. 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.	Kidpower - Playgroup n=42 Participants Playgroup camp 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.
Change in Anxiety Disorders Interview Schedule - Parent Version (ADIS-P)	2.04 score on a scale Standard Deviation 1.56	1.94 score on a scale Standard Deviation 1.91

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Kidpower - Structured Games n=49 Participants Structured Games Camp. 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.	Kidpower - Playgroup n=44 Participants Playgroup camp 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.
Change in Spence Preschool Anxiety Scale (Spence PAS)	-10.4 units on a scale Standard Deviation 11.4	-6.05 units on a scale Standard Deviation 14.9

Adverse Events

Kidpower - Structured Games

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Kidpower - Playgroup

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kate D. Fitzgerald

Columbia University

Phone: 646-774-5681

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place