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Multimodal for Autism Spectrum Disorder
N/A
Waitlist Available
Led By Anjana N Bhat, PhD
Research Sponsored by University of Delaware
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Children with Autism Spectrum Disorder (ASD) between 5 and 15 years of age
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to post-test after 8 weeks of intervention, baseline to follow-up testing after 8 weeks from post-test
Awards & highlights
Summary
This trial will compare the effects of two types of 8-week interventions on social communication and motor skills in school-age children with Autism Spectrum Disorder.
Eligible Conditions
- Autism Spectrum Disorder
- Autism
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to post-test after 8 weeks of intervention, baseline to follow-up testing after 8 weeks from post-test
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to post-test after 8 weeks of intervention, baseline to follow-up testing after 8 weeks from post-test
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2)
Flanker Task of Executive Functioning (EF)
Number of Prosocial Behaviors
+2 moreSecondary outcome measures
2-Minute Walk Test
Developmental Coordination Disorder-Questionnaire
Sensory Processing Measure (SPM)
+1 moreOther outcome measures
Social Communication Questionnaire (SCQ)
Social Responsiveness Scale-Second Edition (SRS-2)
Vineland Adaptive Behavioral Scales (VABS)
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: MultimodalExperimental Treatment1 Intervention
Each child will receive 16 training sessions (8 weeks of training @ 2 sessions per week, approximately 30-45 minutes of interaction time per session) from an expert trainer and parent guidance using telehealth or face-to-face interactions. Within each session, the child will engage in tasks requiring interpersonal synchrony, multilimb coordination (asymmetrical and ipsi/contralateral motions), and balance. Based on feasibility, parents will be given appropriate supplies and trained to promote similar activities at home 1-2 days/week.
Group II: Standard of CareActive Control1 Intervention
Each child will receive 16 training sessions (8 weeks of training @ 2 sessions per week, approximately 30-45 minutes of interaction time per session) from an expert trainer and parent guidance using telehealth or face-to-face interactions. Within each session, the child will engage in seated play focused on reading, building, and art-craft activities. Based on feasibility, parents will be given appropriate supplies and trained to promote similar activities at home 1-2 days/week.
Group III: General MovementActive Control1 Intervention
Each child will receive 16 training sessions (8 weeks of training @ 2 sessions per week, approximately 30-45 minutes of interaction time per session) from an expert trainer and parent guidance using telehealth or face-to-face interactions. Within each session, the child will engage in structured physical activity focused on flexibility, strength, and endurance. Based on feasibility, parents will be given appropriate supplies and trained to promote similar activities at home 1-2 days/week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multimodal
2020
N/A
~1150
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Who is running the clinical trial?
University of DelawareLead Sponsor
156 Previous Clinical Trials
25,526 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
50 Patients Enrolled for Autism Spectrum Disorder
National Institutes of Health (NIH)NIH
2,736 Previous Clinical Trials
7,507,904 Total Patients Enrolled
21 Trials studying Autism Spectrum Disorder
2,450 Patients Enrolled for Autism Spectrum Disorder
National Institute of General Medical Sciences (NIGMS)NIH
273 Previous Clinical Trials
247,962 Total Patients Enrolled
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