Dance for Children With Autism
Primary Purpose
Neurodevelopmental Disorders
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dance
Sponsored by
About this trial
This is an interventional other trial for Neurodevelopmental Disorders
Eligibility Criteria
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 4 to 17
- A diagnosis of a neurodevelopmental disorder
Exclusion Criteria:
- Children younger than 4 years of age
- Children older than 17 years of age
- Children without a neurodevelopmental disorder
- Children who have previously participated in dance classes held by the Dance program called the Expressive Movement Initiative
Sites / Locations
- UCLA David Geffen School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Active Group
Waitlist Control
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
Movement Assessment Battery for Children Checklist
Motor questionnaire. Higher scores indicate a worse outcome
Vineland Adaptive Behavior Scale
A measure of adaptive behavior and motor skills. The minimum value is 21 and maximum value is 140. Higher scores indicate a better outcome.
Perceived Motor Competence Scale Parent Report
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.
Perceived Motor Competence Scale Child Report
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.
Brief Observation of Social Communication Change
A videotaped observational coding of a child's social communication behavior.
Parenting Stress Scale
Measure of factors related to caregiver stress
Lifespan Self-Esteem Scale
Measure of self-esteem/self-confidence
Autism Impact Measure
Measure of child's behaviors and the degree of impact on everyday functioning
Quantitative Gait Assessment
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.
Secondary Outcome Measures
Social responsiveness scale
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
Survey for adults
Measure of child's physical activity levels and engagement
Survey for children
measure of self physical activity levels and engagement
Full Information
NCT ID
NCT04762290
First Posted
February 17, 2021
Last Updated
September 15, 2023
Sponsor
University of California, Los Angeles
Collaborators
Health Resources and Services Administration (HRSA)
1. Study Identification
Unique Protocol Identification Number
NCT04762290
Brief Title
Dance for Children With Autism
Official Title
Dance for Children With Autism: a Therapeutic Intervention to Improve Motor Ability, Quality of Life, Social Communication, Perceived Physical Competence, and Self-efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2021 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Health Resources and Services Administration (HRSA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodevelopmental Disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study model is a waitlist control. There is an active group and a waitlist control group.
Masking
Outcomes Assessor
Masking Description
Certain direct outcome measure assessors will be masked
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Dance
Other Intervention Name(s)
expressive movement
Intervention Description
The intervention is a series of expressive dance movements.
Primary Outcome Measure Information:
Title
Movement Assessment Battery for Children Checklist
Description
Motor questionnaire. Higher scores indicate a worse outcome
Time Frame
10 minutes
Title
Vineland Adaptive Behavior Scale
Description
A measure of adaptive behavior and motor skills. The minimum value is 21 and maximum value is 140. Higher scores indicate a better outcome.
Time Frame
45 minutes
Title
Perceived Motor Competence Scale Parent Report
Description
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.
Time Frame
5 minutes
Title
Perceived Motor Competence Scale Child Report
Description
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.
Time Frame
5 minutes
Title
Brief Observation of Social Communication Change
Description
A videotaped observational coding of a child's social communication behavior.
Time Frame
10 minutes
Title
Parenting Stress Scale
Description
Measure of factors related to caregiver stress
Time Frame
5 minutes
Title
Lifespan Self-Esteem Scale
Description
Measure of self-esteem/self-confidence
Time Frame
2 minutes
Title
Autism Impact Measure
Description
Measure of child's behaviors and the degree of impact on everyday functioning
Time Frame
10 minutes
Title
Quantitative Gait Assessment
Description
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.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Social responsiveness scale
Description
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
Time Frame
15 minutes
Title
Survey for adults
Description
Measure of child's physical activity levels and engagement
Time Frame
10 minutes
Title
Survey for children
Description
measure of self physical activity levels and engagement
Time Frame
10 minutes
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rujuta B Wilson, MD
Phone
12085206778
Email
rbhatt@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rujuta B Wilson, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA David Geffen School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rujuta B Wilson, MD
Phone
208-520-6778
Email
rbhatt@mednet.ucla.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
At this time, there is not a plan to provide confidential individual participant data to other researchers. This study does not entail a medical condition or study of medication for a specific medical or genetic condition.
Learn more about this trial
Dance for Children With Autism
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