- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04762290
Dance for Children With Autism (Dance and NDDs)
Dance for Children With Autism: a Therapeutic Intervention to Improve Motor Ability, Quality of Life, Social Communication, Perceived Physical Competence, and Self-efficacy
Motor impairments are prominent in individuals with autism spectrum disorder (ASD) and other neurodevelopment disorders, and these impairments often impact the individual's ability to engage in organized physical activity programs (OPA). While many studies have identified dance and creative movement to be retrospectively and anecdotally therapeutic, there remains a paucity of literature regarding outcomes associated with these programs, and specifically, their impact on (1) perceived and objective gross and fine motor skills, (2) perceived ability to succeed in related or divergent goals or tasks, (3) quality of life for affected individuals and their caregivers. (4) adaptive function and socialization, (5) social communication
This study explores the impact of organized dance and creative movement classes on children with autism (ages 8-12) and their caregivers. Participants will complete a set of surveys and assessments designed to measure the above metrics (labeled 1, 2, and 3) at their first study visit. This initial assessment is expected to take place within two weeks prior to beginning the intervention (either a wait period or a series of 1-hour dance classes, which children will attend weekly for 10 weeks). The second and final study visit will consist of a similar set of surveys and assessments designed to measure the same metrics within the two weeks following completion of the dance class series. Participants who have completed the wait period at this point will then begin their set of 10 weekly dance classes. Expected duration of participation in the study is no longer than 14 weeks in total.
Study Overview
Detailed Description
Motor impairments are prominent in individuals with autism spectrum disorder (ASD) and other neurodevelopment disorders, and these impairments often impact the individual's ability to engage in organized physical activity programs (OPA). While many studies have identified dance and creative movement to be retrospectively and anecdotally therapeutic, there remains a paucity of literature regarding outcomes associated with these programs, and specifically, their impact on (1) perceived and objective gross and fine motor skills, (2) perceived ability to succeed in related or divergent goals or tasks, (3) quality of life for affected individuals and their caregivers, (4) Adaptive function and socialization, (5) social communication.
This study explores the impact of organized dance and creative movement classes on children with autism (ages 8-12) and their caregivers. Participants will complete a set of surveys and assessments designed to measure the above metrics (labeled 1, 2,3, 4, 5) at their first study visit. This initial assessment is expected to take place within two weeks prior to beginning the intervention (either a wait period or a series of 1-hour dance classes, which children will attend weekly for 10 weeks). The second and final study visit will consist of a similar set of surveys and assessments designed to measure the same metrics within the two weeks following completion of the dance class series. Participants who have completed the wait period at this point will then begin their set of 10 weekly dance classes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rujuta B Wilson, MD
- Phone Number: 12085206778
- Email: rbhatt@mednet.ucla.edu
Study Locations
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California
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Los Angeles, California, United States, 90095
- Recruiting
- UCLA david geffen school of medicine
-
Contact:
- Rujuta B Wilson, MD
- Phone Number: 208-520-6778
- Email: rbhatt@mednet.ucla.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- There are no inclusion criteria based on gender, pregnancy/childbearing potential, race, ethnicity, or language spoken
- Children must be between the ages of 8 to 12
- A diagnosis of a autism
- Complex speech/fully verbal
Exclusion Criteria:
- Children younger than 8 years of age
- Children older than 12 years of age
- Children without a diagnosis of autism
- Children who are not fully verbal (i.e. phrased speech, single words, or non-speaking)
- Children who have previously participated in dance classes held by the Dance program called the Expressive Movement Initiative
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active Group
This group will receive the intervention in the first 10 weeks of the study.
The intervention is a dance intervention that consists of a series of expressive movements.
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The intervention is a series of expressive dance movements.
Other Names:
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Other: Waitlist Control
This group will receive the intervention in the second 10 weeks of the study (after the active group and after pre-post assessments in the first 10 weeks during the time of no intervention).
|
The intervention is a series of expressive dance movements.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vineland Adaptive Behavior Scale
Time Frame: 45 minutes
|
A measure of adaptive behavior and motor skills.
The minimum value is 21 and maximum value is 140.
Higher scores indicate a better outcome.
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45 minutes
|
Perceived Motor Competence Scale Parent Report
Time Frame: 5 minutes
|
A measure of perceived motor skills in the child.
Higher scores indicate a better outcome.
Scores are based on a likert scale of 1-4.
The minimum score is 18 and the maximum score is 72.
|
5 minutes
|
Perceived Motor Competence Scale Child Report
Time Frame: 5 minutes
|
A measure of perceived motor skills in the child (participant).
Higher scores indicate a better outcome.
The minimum score is 13 and the maximum score is 52.
|
5 minutes
|
Brief Observation of Social Communication Change
Time Frame: 10 minutes
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A videotaped observational coding of a child's social communication behavior.
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10 minutes
|
Movement Assessment Battery for Children Checklist
Time Frame: 10 minutes
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Motor questionnaire.
Higher scores indicate a worse outcome
|
10 minutes
|
Parenting Stress Scale
Time Frame: 5 minutes
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Measure of factors related to caregiver stress
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5 minutes
|
Lifespan Self-Esteem Scale
Time Frame: 2 minutes
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Measure of self-esteem/self-confidence
|
2 minutes
|
Autism Impact Measure
Time Frame: 10 minutes
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Measure of child's behaviors and the degree of impact on everyday functioning
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10 minutes
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Quantitative Gait Assessment
Time Frame: 10 minutes
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Direct motor measure in which the child walks across a mat with embedded sensors.
The mat used in this study is the Zeno Walkway Gait Analysis System.
This assessment includes self-regulated walking, fast walking, and standing balance.
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10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social responsiveness scale
Time Frame: 15 minutes
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A measure of social communication and autism traits.
Higher scores indicate a worse outcome.
A total T-score of 76 or higher is considered severe and strongly associated with a clinical diagnosis of Autistic Disorder.
T-scores of 66 through 75 are interpreted as indicating Moderate deficiencies in reciprocal social behavior that are clinically significant and lead to substantial interference in everyday social interactions.
T-scores of 60 to 65 are in the Mild range and indicate mild to moderate deficits in social interaction.T scores of 59 and below are considered to be within typical limits and generally not associated with clinically significant ASD
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15 minutes
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Survey for adults
Time Frame: 10 minutes
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Measure of child's physical activity levels and engagement
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10 minutes
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Survey for children
Time Frame: 10 minutes
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measure of self physical activity levels and engagement
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10 minutes
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rujuta B Wilson, MD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-001680-AM-00005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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