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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04762290
Other study ID # 20-001680-AM-00005
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 31, 2021
Est. completion date March 31, 2024

Study information

Verified date September 2023
Source University of California, Los Angeles
Contact Rujuta B Wilson, MD
Phone 12085206778
Email rbhatt@mednet.ucla.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 31, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers No
Gender All
Age group 8 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Dance
The intervention is a series of expressive dance movements.

Locations

Country Name City State
United States UCLA David Geffen School of Medicine Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles Health Resources and Services Administration (HRSA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Movement Assessment Battery for Children Checklist Motor questionnaire. Higher scores indicate a worse outcome 10 minutes
Primary 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. 45 minutes
Primary 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. 5 minutes
Primary 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. 5 minutes
Primary Brief Observation of Social Communication Change A videotaped observational coding of a child's social communication behavior. 10 minutes
Primary Parenting Stress Scale Measure of factors related to caregiver stress 5 minutes
Primary Lifespan Self-Esteem Scale Measure of self-esteem/self-confidence 2 minutes
Primary Autism Impact Measure Measure of child's behaviors and the degree of impact on everyday functioning 10 minutes
Primary 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. 10 minutes
Secondary 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 15 minutes
Secondary Survey for adults Measure of child's physical activity levels and engagement 10 minutes
Secondary Survey for children measure of self physical activity levels and engagement 10 minutes
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