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Treatment as Usual + High Intensity Multi-Modal for Autism Spectrum Disorder

N/A
Waitlist Available
Research Sponsored by University of Kansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights

Summary

This trial is testing a new intervention to promote spoken word production in children with autism who have minimal verbal skills. The intervention is based on principles of phonotactic probability and neighborhood density in combination with augmentative and alternative communication, and will be evaluated using a Sequential Multiple Assignment Randomized Trials design.

Eligible Conditions
  • Autism Spectrum Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Expressive Word Acquisition
Change in Receptive Word Acquisition
Expressive Word Acquisition
+1 more
Secondary study objectives
Change in Communication Complexity Scale
Communication Complexity Scale
Other study objectives
Change in Consonant Inventory
Consonant Inventory

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment as Usual + Multi-ModalExperimental Treatment2 Interventions
Teacher provided with word list for 4 weeks followed by 3 Times Per Week - Speech sound practice, Joint book reading, AAC activity, Computerized instruction component for 12 weeks
Group II: Treatment as Usual + High Intensity Multi-ModalExperimental Treatment2 Interventions
Teacher provided with word list for 4 weeks followed by Speech sound practice, Joint book reading, AAC activity, Computerized instruction component for 5 times per week for 12 weeks
Group III: Multi-Modal + High Intensity Multi-ModalExperimental Treatment2 Interventions
3 Times Per Week - Speech sound practice, Joint book reading, AAC activity, Computerized instruction component for 4 weeks, increasing to 5 times per week for 12 weeks
Group IV: Multi-ModalExperimental Treatment1 Intervention
3 Times Per Week for 4 weeks - Speech sound practice, Joint book reading, AAC activity, Computerized instruction component followed by more treatment for 12 weeks
Group V: Treatment as UsualPlacebo Group1 Intervention
Teacher provided with word list for 4 weeks followed by more treatment as usual for 12 weeks

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Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,988 Previous Clinical Trials
2,683,463 Total Patients Enrolled
34 Trials studying Autism Spectrum Disorder
9,664 Patients Enrolled for Autism Spectrum Disorder
University of KansasLead Sponsor
148 Previous Clinical Trials
326,251 Total Patients Enrolled
6 Trials studying Autism Spectrum Disorder
1,212 Patients Enrolled for Autism Spectrum Disorder
~7 spots leftby Sep 2025
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