Anxiety DisordersNCT04960813
Kidpower Camp - Structured Games or Playgroup
A study testing Structured games and Playgroup in people with Anxiety Disorders, run by Columbia University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 48 to 71 months
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Structured games and Playgroup
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Jul 2021to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between ages 4 -5.99 years at time of consent
- Children that have a primary clinical diagnosis of separation anxiety disorder, social anxiety disorder, generalized anxiety disorder, panic disorder, and/or obsessive-compulsive disorder
- Written informed consent by a parent/legal guardian and verbal assent from participant
- Fluent in English
Who cannot join
- History of head injury
- History of serious medical or neurological illness
- History of post-traumatic stress disorder (PTSD)
- History of major depressive disorder (MDD)
- Current psychotherapy or behavioral interventions
- History of Neurodevelopmental delay, autism spectrum disorder (ASD), or intellectual disability
Show all 10Show fewer
- Currently taking medications that affect central nervous system functioning
- Primary clinical diagnosis is selective mutism or specific phobia
- Recent history of physically aggressive behaviors that have caused harm to other children
- Sibling of a child who has participated or is currently participating in this protocol
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48109
Michigan State University
East Lansing, Michigan, 48824
Columbia University
New York, New York, 10019
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Neurally Targeted Interventions to Reduce Early Childhood Anxiety
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.
- Conditions
- Anxiety Disorders
- Being tested
- Structured games, Playgroup
- Keywords
- Effortful Control, Preschool, Error-related negativity
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured gamesBehavioural
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.
PlaygroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Kidpower - Structured Games | Experimental | Structured Games Camp. Receives: Behavioral: Structured games |
| Kidpower - Playgroup | Active comparator | Playgroup camp Receives: Behavioral: Playgroup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Pre-treatment (baseline) up to post-treatment assessments (approximately 4-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start7 Jul 2021
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children will be randomized 1:1 to structured games or a playgroup. The structured games and playgroup will run in parallel.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Michigan State University, University of Michigan, University of Maryland
- Responsible party
- Principal investigator, Kate D. Fitzgerald, MD, Columbia University
- Investigators
- Kate D Fitzgerald, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960813
- Sponsor's protocol ID
- AAAU8442
- Other IDs
- 1R33MH121641-01A1, NYSPI 8263
- Status last verified
- Apr 2025
- First submitted
- 2 Jul 2021
- Last updated
- 30 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurally Targeted Interventions to Reduce Early Childhood Anxiety
- ClinicalTrials.gov ID
- NCT04960813
- Acronym / sponsor ID
- AAAU8442
- Conditions
- Anxiety Disorders
- Keywords
- Effortful Control, Preschool, Error-related negativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Michigan State University, University of Michigan, University of Maryland
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 14 Jul 2021 (actual)
- Results
- Posted 30 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Children will be randomized 1:1 to structured games or a playgroup. The structured games and playgroup will run in parallel.
| Arm | Type | Receives |
|---|---|---|
| Kidpower - Structured Games | Experimental | Behavioral: Structured gamesStructured Games Camp. |
| Kidpower - Playgroup | Active comparator | Behavioral: PlaygroupPlaygroup camp |
Who may qualify
- Ages
- 48 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children between ages 4 -5.99 years at time of consent
- Children that have a primary clinical diagnosis of separation anxiety disorder, social anxiety disorder, generalized anxiety disorder, panic disorder, and/or obsessive-compulsive disorder
- Written informed consent by a parent/legal guardian and verbal assent from participant
- Fluent in English
Key exclusion criteria (10 listed)
- History of head injury
- History of serious medical or neurological illness
- History of post-traumatic stress disorder (PTSD)
- History of major depressive disorder (MDD)
- Current psychotherapy or behavioral interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured gamesCamp 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. | Behavioural | Kidpower - Structured Games |
| PlaygroupCamp 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. | Behavioural | Kidpower - Playgroup |
Primary outcome
Change in Error Related Negativity (ERN)
Time frame: 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.
Change in National Institutes of Health (NIH) Toolbox Effortful Control (EC) Composite Scale
Time frame: 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.
Change in Clinical Global Impressions -Severity and Improvement Scales
Time frame: 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.
2 secondary outcomes
Change in Anxiety Disorders Interview Schedule - Parent Version (ADIS-P)
Time frame: Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)
Change in Spence Preschool Anxiety Scale (Spence PAS)
Time frame: Pre-treatment (baseline) up to post-treatment assessments (approximately 4-6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Anxiety Disorders
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Recruiting
Stress and Anxiety Effects on Valuation
Reward Value Level
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate D Fitzgerald, M.D. principal investigator
Columbia University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured games and Playgroup in people with Anxiety Disorders, run by Columbia University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Error Related Negativity (ERN) (time frame: Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.