Direct Instruction Language for Learning in Autism Spectrum Disorder

Completed · Not applicable

Conditions studied: Autism Spectrum Disorder, Moderate Language Delay

In brief

The purpose of this study is to test whether Direct Instruction - Language for Learning (DI-LL) is an effective way to teach language skills to children with autism spectrum disorder (ASD) and moderate language delay. Direct Instruction - Language for Learning (DI-LL) uses face to face instruction and specific lessons to teach children language skills. This method has been used previously in children with language delays, but it has not been carefully studied in children with autism spectrum disorder. This study will compare DI-LL and ongoing treatment as usual to treatment as usual (speech therapy, language services, etc.) alone.

Key facts

Study ID: NCT02483910
Run by: Emory University
People needed: 137
Starts: 2015-10-01
Expected to finish: 2020-11-24
Last updated by the study team: 2021-01-06

Who can join

Age: 4 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Meets one of the following age and Clinical Evaluation of Language Fundamentals -version 4 (CELF-4) or Clinical Evaluation of Language Fundamentals Preschool-2 (CELF-P) score combinations:
Males and females > 4 years and < 7 years 11 months of age in with a score < 80 on the CELF-4 or the CELF-P, or
Males and females > 5 years and < 7 years 11 months of age with a score > 40 on the CELF-4, or
Males and females > 4 years and < 6 years 5 months of age with a score > 45 CELF-P
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of autism spectrum disorder (ASD) established by clinical assessment, corroborated by the Social Communication Questionnaire and the Autism Diagnostic Observational Schedule
A score < 80 on the Core Language score of the Clinical Evaluation of Language Fundamentals - 4 if > 6 years 5 months
Stable educational plan with no planned changes in the intensity of treatment for 6 months
Stable community treatment program (e.g., speech therapy or occupational therapy) with no planned changes in the treatment for 6 months. (Otherwise eligible subjects with anticipated changes in their community treatment program in the near term will be invited to return when the transition has been accomplished).
English is spoken in the home and at least one parent is able to read, write and speak English
Psychotropic medication free or on stable psychotropic medication (no changes in past 6 weeks and no planned changes for the next 6 months)

You may not qualify if…

Presence of a known serious medical condition in the child (based on medical history) that would interfere with child ability to participate in the study
On examination, child has less than 5 words and unable to imitate at least 5 words
Children > 6 years 5 months who achieve a score of 40 on the CELF-4 (and judged to be below 40 by the speech language pathologist)
Presence of a current serious behavioral problem or psychiatric condition in the child that would require another treatment (e.g., psychotic disorder, major depression, moderate or greater aggression, severe disruptive behavior) based on all available information collected at screening
Currently receiving Direct Instruction Language for Learning (DI-LL) or participation in a DI-LL program in the past 2 years
Primary mode of communication is a speech generating device (e.g., DynaVox, Gotalk, Proloquo2go)
On psychotropic medication, but regimen is not stable (Once stabilized, eligibility could be reconsidered.)

Where it is running

Marcus Autism Center - Children's Healthcare of Atlanta — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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