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| ID | Type | Description | Link |
|---|---|---|---|
| 1R33MH121641-01A1 | U.S. NIH Grant/Contract | View source | |
| NYSPI 8263 | Other Identifier | New York State Psychiatric Institute Institutional Review Board |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Michigan State University | OTHER |
| University of Michigan | OTHER |
| University of Maryland |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kidpower - Structured Games | Experimental | Structured Games Camp. |
|
| Kidpower - Playgroup | Active Comparator | Playgroup camp |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured games | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Error Related Negativity (ERN) | 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. | Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks) |
| Change in National Institutes of Health (NIH) Toolbox Effortful Control (EC) Composite Scale | 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. | Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks) |
| Change in Clinical Global Impressions -Severity and Improvement Scales | 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. | Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kate D Fitzgerald, M.D. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States | ||
| Michigan State University |
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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.
The numbers in the Participant Flow represent individual participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | We could not retrieve the ages of 4 participants due to destroyed paperwork for de-identification purposes. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Error Related Negativity (ERN) | 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. | 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. | Posted | Mean | Standard Deviation | millivolts | Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks) |
|
3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kate D. Fitzgerald | Columbia University | 646-774-5681 | kf2688@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2024 | Feb 28, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| OTHER |
Children will be randomized 1:1 to structured games or a playgroup. The structured games and playgroup will run in parallel.
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The rater will be blinded to which intervention, structured games or playgroup, child participants receive.
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| Playgroup | Behavioral | 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. |
|
| Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks) |
| Change in Spence Preschool Anxiety Scale (Spence PAS) | 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. | Pre-treatment (baseline) up to post-treatment assessments (approximately 4-6 weeks) |
| East Lansing |
| Michigan |
| 48824 |
| United States |
| Columbia University | New York | New York | 10019 | United States |
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | 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. |
|
|
| Primary | Change in National Institutes of Health (NIH) Toolbox Effortful Control (EC) Composite Scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks) |
|
|
|
| Primary | Change in Clinical Global Impressions -Severity and Improvement Scales | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks) |
|
|
|
| Secondary | Change in Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks) |
|
|
|
| Secondary | Change in Spence Preschool Anxiety Scale (Spence PAS) | 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. | Posted | Mean | Standard Deviation | units on a scale | Pre-treatment (baseline) up to post-treatment assessments (approximately 4-6 weeks) |
|
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|
| 0 |
| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | 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. | 0 | 53 | 0 | 53 | 0 | 53 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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