Anxiety Disorders
Conditions
Keywords
Effortful Control, Preschool, Error-related negativity
Brief 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. 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.
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.
Sponsors
National Institute of Mental Health (NIMH)
Michigan State University
University of Michigan
University of Maryland
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The rater will be blinded to which intervention, structured games or playgroup, child participants receive.
Intervention model description
Children will be randomized 1:1 to structured games or a playgroup. The structured games and playgroup will run in parallel.
Eligibility
Sex/Gender
ALL
Age
48 Months to 71 Months
Healthy volunteers
No
Inclusion criteria
1. Children between ages 4 -5.99 years at time of consent 2. Children that have a primary clinical diagnosis of separation anxiety disorder, social anxiety disorder, generalized anxiety disorder, panic disorder, and/or obsessive-compulsive disorder 3. Written informed consent by a parent/legal guardian and verbal assent from participant 4. Fluent in English
Exclusion criteria
1. History of head injury 2. History of serious medical or neurological illness 3. History of post-traumatic stress disorder (PTSD) 4. History of major depressive disorder (MDD) 5. Current psychotherapy or behavioral interventions 6. History of Neurodevelopmental delay, autism spectrum disorder (ASD), or intellectual disability 7. Currently taking medications that affect central nervous system functioning 8. Primary clinical diagnosis is selective mutism or specific phobia 9. Recent history of physically aggressive behaviors that have caused harm to other children 10. Sibling of a child who has participated or is currently participating in this protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Error Related Negativity (ERN) | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | 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. |
| Change in Spence Preschool Anxiety Scale (Spence PAS) | 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. |
Countries
United States
Participant flow
Recruitment details
The numbers in the Participant Flow represent individual participants.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 57 |
| 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. | 53 |
| Total | 110 |
Baseline characteristics
| Characteristic | Kidpower - Structured Games | Total | Kidpower - Playgroup |
|---|---|---|---|
| Age, Continuous | 4.45 years STANDARD_DEVIATION 0.5 | 4.45 years STANDARD_DEVIATION 0.52 | 4.46 years STANDARD_DEVIATION 0.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 21 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 85 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 15 Participants | 24 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) White | 33 Participants | 63 Participants | 30 Participants |
| Region of Enrollment United States | 57 Participants | 110 Participants | 53 Participants |
| Sex: Female, Male Female | 40 Participants | 61 Participants | 21 Participants |
| Sex: Female, Male Male | 17 Participants | 49 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 53 |
| other Total, other adverse events | 0 / 57 | 0 / 53 |
| serious Total, serious adverse events | 0 / 57 | 0 / 53 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kidpower - Structured Games | Change in Clinical Global Impressions -Severity and Improvement Scales | CGI-S | 1.16 score on a scale | Standard Deviation 0.93 |
| Kidpower - Structured Games | Change in Clinical Global Impressions -Severity and Improvement Scales | CGI-I | 2.44 score on a scale | Standard Deviation 0.76 |
| Kidpower - Playgroup | Change in Clinical Global Impressions -Severity and Improvement Scales | CGI-S | 1.14 score on a scale | Standard Deviation 0.98 |
| Kidpower - Playgroup | Change in Clinical Global Impressions -Severity and Improvement Scales | CGI-I | 2.67 score on a scale | Standard Deviation 0.87 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kidpower - Structured Games | Change in Error Related Negativity (ERN) | -0.169 millivolts | Standard Deviation 8.129 |
| Kidpower - Playgroup | Change in Error Related Negativity (ERN) | -1.192 millivolts | Standard Deviation 10.194 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kidpower - Structured Games | Change in National Institutes of Health (NIH) Toolbox Effortful Control (EC) Composite Scale | .3265 score on a scale | Standard Deviation 0.628 |
| Kidpower - Playgroup | Change in National Institutes of Health (NIH) Toolbox Effortful Control (EC) Composite Scale | .406 score on a scale | Standard Deviation 0.5655 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kidpower - Structured Games | Change in Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | 2.04 score on a scale | Standard Deviation 1.56 |
| Kidpower - Playgroup | Change in Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | 1.94 score on a scale | Standard Deviation 1.91 |
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.
Time frame: Pre-treatment (baseline) up to post-treatment assessments (approximately 4-6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kidpower - Structured Games | Change in Spence Preschool Anxiety Scale (Spence PAS) | -10.4 units on a scale | Standard Deviation 11.4 |
| Kidpower - Playgroup | Change in Spence Preschool Anxiety Scale (Spence PAS) | -6.05 units on a scale | Standard Deviation 14.9 |