Dance for Children With Neurodevelopmental Disorders (Dance and NDDs)

• ClinicalTrials.gov Identifier: NCT04762290
• Recruitment Status: Recruiting
• First Posted: February 21, 2021
• Last Update Posted: February 24, 2021
• Sponsor: University of California, Los Angeles
• Collaborator: Health Resources and Services Administration (HRSA)
• Information provided by (Responsible Party): Rujuta B. Wilson, MD, University of California, Los Angeles

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, (5) social communication

This study explores the impact of organized dance and creative movement classes on children with neurodevelopmental disorders (ages 4-17) 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.

Condition or disease	Intervention/treatment	Phase
Neurodevelopmental Disorders	Other: Dance	Not Applicable

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 neurodevelopmental disorders (ages 4-17) 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The study model is a waitlist control. There is an active group and a waitlist control group.
• Masking: Single (Outcomes Assessor)
• Masking Description: Certain direct outcome measure assessors will be masked
• Primary Purpose: Other
• Official Title: Dance for Children With Neurodevelopment Disorders: a Therapeutic Intervention to Improve Motor Ability, Quality of Life, Social Communication, Perceived Physical Competence, and Self-efficacy
• Actual Study Start Date: January 31, 2021
• Estimated Primary Completion Date: October 30, 2021
• Estimated Study Completion Date: March 2, 2022

Arms and Interventions

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.	Other: Dance; The intervention is a series of expressive dance movements.; Other Name: expressive movement
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).	Other: Dance; The intervention is a series of expressive dance movements.; Other Name: expressive movement

Outcome Measures

Primary Outcome Measures :

1. Movement Assessment Battery for Children Checklist [ Time Frame: 10 minutes ]
   Motor questionnaire
2. Parenting Stress Index [ Time Frame: 20 minutes ]
   Measure of factors related to caregiver stress
3. 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.
4. 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. 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.
6. Brief Observation of Social Communication Change [ Time Frame: 10 minutes ]
   A videotaped observational coding of a child's social communication behavior.
7. Children's Hope Scale [ Time Frame: 5 minutes ]
   A measure of children's self-perception of goal attainability. Lower scores indicate a worse outcome. The minimum score is 6 and the maximum score is 36.
8. Pediatric Quality of Life Inventory [ Time Frame: 5 minutes ]
   Quality of life measures
9. Piers Harris Self Concept Scale [ Time Frame: 15 minutes ]
   A measure of self abilities. Lower scores indicate a worse outcome. T-scores of 29 and below fall in the very low range. T-scores of 30-39 fall in the low range. T-scores of 40-44 fall in the low average range. T-scores of 45-55 fall in the average range. T-scores of 56-59 fall in the high average range. T-scores of 60-69 fall in the high range. T-scores of 70 and above fall in the very high range.

Secondary Outcome Measures :

1. Social responsiveness scale [ Time Frame: 15 minutes ]
   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
2. Social communication questionnaire [ Time Frame: 15 minutes ]
   Measures social communication
3. Survey for adults [ Time Frame: 10 minutes ]
   Measure of child's physical activity levels and engagement
4. Survey for children [ Time Frame: 10 minutes ]
   measure of self physical activity levels and engagement

Eligibility Criteria

• Ages Eligible for Study: 4 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Rujuta B Wilson, MD; 12085206778; rbhatt@mednet.ucla.edu

Locations

United States, California

UCLA David Geffen School of Medicine; Recruiting

Los Angeles, California, United States, 90095

Contact: Rujuta B Wilson, MD 208-520-6778 rbhatt@mednet.ucla.edu

Sponsors and Collaborators

University of California, Los Angeles

Health Resources and Services Administration (HRSA)

Investigators

• Principal Investigator: Rujuta B Wilson, MD; UCLA David Geffen School of Medicine

More Information

• Responsible Party: Rujuta B. Wilson, MD, Assistant Professor, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT04762290
• Other Study ID Numbers: 20-001680-AM-00005
• First Posted: February 21, 2021
• Last Update Posted: February 24, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neurodevelopmental Disorders; Mental Disorders