Kidpower Camp - Structured Games or Playgroup

Browse trials for

• Anxiety Disorders 4,868

Keywords

• Effortful Control
• Preschool
• Error-related negativity

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 158 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Lead sponsor

Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.

Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.

Study arms

• Experimental
  Kidpower - Structured Games

  Structured Games Camp.

  Behavioral: Structured games

• Active comparator
  Kidpower - Playgroup

  Playgroup camp

  Behavioral: Playgroup

Interventions

• BehavioralStructured 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.

• BehavioralPlaygroup

  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 outcomes

1. 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.

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

2. 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.

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

3. 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.

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

Secondary outcomes

1. 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.

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

2. 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.

   Time frame: Pre-treatment (baseline) up to post-treatment assessments (approximately 4-6 weeks)

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · May 17, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No