NCT04762290

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

April 16, 2025

Status Verified

March 1, 2025

Enrollment Period

3.6 years

First QC Date

February 17, 2021

Last Update Submit

April 14, 2025

Conditions

Outcome Measures

Primary Outcomes (9)

  • Movement Assessment Battery for Children Checklist

    Motor questionnaire. Higher scores indicate a worse outcome

    10 minutes

  • 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

  • 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

  • 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

  • Brief Observation of Social Communication Change

    A videotaped observational coding of a child's social communication behavior.

    10 minutes

  • Parenting Stress Scale

    Measure of factors related to caregiver stress

    5 minutes

  • Lifespan Self-Esteem Scale

    Measure of self-esteem/self-confidence

    2 minutes

  • Autism Impact Measure

    Measure of child's behaviors and the degree of impact on everyday functioning

    10 minutes

  • 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 Outcomes (3)

  • Social responsiveness scale

    15 minutes

  • Survey for adults

    10 minutes

  • Survey for children

    10 minutes

Study Arms (2)

Active Group

ACTIVE COMPARATOR

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

Waitlist Control

OTHER

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

Interventions

DanceOTHER

The intervention is a series of expressive dance movements.

Also known as: expressive movement
Active GroupWaitlist Control

Eligibility Criteria

Age8 Years - 12 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children must be between the ages of 8 to 12
  • A diagnosis of a autism
  • Complex speech/fully verbal

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA David Geffen School of Medicine

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • Anderson JT, Toolan C, Coker E, Singer H, Pham D, Jackson N, Lord C, Wilson RB. A novel dance intervention program for children and adolescents with developmental disabilities: a pilot randomized control trial. BMC Sports Sci Med Rehabil. 2024 May 14;16(1):109. doi: 10.1186/s13102-024-00897-3.

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Rujuta B Wilson, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Certain direct outcome measure assessors will be masked
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The study model is a waitlist control. There is an active group and a waitlist control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 17, 2021

First Posted

February 21, 2021

Study Start

January 31, 2021

Primary Completion

August 30, 2024

Study Completion

August 31, 2024

Last Updated

April 16, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

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.

Locations