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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06295705
Other study ID # 5230588
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2, 2024
Est. completion date April 2025

Study information

Verified date April 2024
Source Loma Linda University
Contact Julie Kugel, OTD
Phone (909) 558-4628
Email jkugel@llu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will explore the effectiveness of dance as an intervention to promote social-emotional health within children with ASD.


Description:

The study will look children with ASD's response to a 7-week occupational therapy led dance program in regards to social-emotional health. This will include exploring the effect on change of social-emotional behavior in children with ASD after being exposed to dance intervention through comparing the quantitative measurements of pre- and post-assessment scores of the Developmental Profile 4 (DP-4), analysis of the qualitative measurements of pre- and post-social-emotional behaviors via child report, and analysis of qualitative observations of social-emotional behavior through reviewing video recording of dance classes. Additionally, parents' perspectives will be explored through post-interview questions to share their observations of their child's experience.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date April 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 7 Years to 11 Years
Eligibility Inclusion Criteria for Youth Participants - Elementary school children ages 7-11. - Parent/caregiver/guardian must provide proof of an Individualized Education Plan (IEP) with a Primary Eligibility of Autism. o Parent/caregiver/guardian must provide proof of IEP and eligibility. - Will speak and understand English. - Able to physically participate in the dance program without the use of adaptive equipment. - Answer yes to the following Skillset Checklist (Per parent/caregiver/guardian report): - Follow 1- and 2-step instructions. - Follow structured activities with supervision (e.g., visual schedule, routine). - Previous participation in extracurricular group activities over the last 6 months - 1 year (e.g., structured sports). - Minimum 5-minutes of attention to task. Exclusion Criteria: - No IEP Primary Eligibility of Autism. - No children participants younger than 7. - No children participants older than 11.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Hip-Hop Dance
I. Week 1 - Session 1 Daily Check-In Warm-Up: Mobility/Grooves Lesson: Style - Hip-Hop Cool-Down: Deep Breathing Debrief Check-In II. Week 2 - Session 2 Daily Check-In Warm-Up: Mobility/Grooves Lesson: Style - Locking Cool-Down: Instructed Yoga Debrief Check-In III. Week 3 - Session 3 Daily Check-In Warm-Up: Mobility/Grooves Lesson: Style - Breaking Cool-Down: Sensory Time Debrief Check-In IV. Week 4 - Session 4 Daily Check-In Warm-Up: Mobility/Grooves Lesson: Style - Popping Cool-Down: Animal Deep Breathing Debrief Check-In V. Week 5 - Session 5 Daily Check-In Warm-Up: Mobility/Grooves Lesson: Learn Showcase Routine Cool-Down: Animal Instructed Yoga Debrief Check-In VI. Week 6 - Session 6 Daily Check-In Warm-Up: Mobility/Grooves Lesson: Review Showcase Routine Cool-Down: Sensory Time Debrief Check-In VII. Week 7 - Dance Showcase

Locations

Country Name City State
United States Loma Linda University Health Loma Linda California

Sponsors (1)

Lead Sponsor Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Child Description of Impact on Social-Emotional Health Subject will be asked to describe emotional state immediately prior to weekly dance intervention and immediately after dance intervention completed. Subject will be asked to verbalize emotional state or choose an icon to represent emotional state. Interviewer will record subject response. Effectiveness will be measured based on verbal or visual responses between 3 options: "Happy", "Sad", or "Okay", where "Happy" is considered effective, "Sad" considered to be ineffective, or if the responses are the same before and after than there is no change. This is a composite measurement over the course of 7 weeks. Change between baseline (time of enrollment) and Week 7
Secondary Parent Perspective of Impact on Social-Emotional Health Parent will complete the Developmental Profile 4 (DP-4) assessment pre- and post-program regarding the child's social-emotional behavior. Effectiveness will be measured on responses between "Yes" and "No", where "Yes" is applicable to the parent's child, and "No" is not applicable. This is a composite measurement with 1 domain and 36 sub questions of the assessment before and after the program. Change between baseline (time of enrollment) and Week 7 (program completion)
Secondary Change in Social-Emotional Behavior Subjects will be audio/video recorded in each dance class weekly. Researcher will observe and analyze recordings using a developed observation checklist of each subject. Effectiveness will be measured by responses of "Observed" and "Not Observed", where "Observed" is witness in the subject and is effective, and "Not Observed" is not witnessed in the subject and is ineffective.This is a composite measurement over the course of 7 weeks. Change between baseline (time of enrollment) and Week 7 (program completion)
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