Direct Instruction Language for Learning in Autism Spectrum Disorder

Autism spectrum disorder (ASD) is a chronic condition of early childhood onset defined by
social impairment and repetitive behavior, and affecting 6 to 14 children per 1000 worldwide.
Language and communication impairments are among the most common parental concerns about
their children with ASD. Untreated language impairments are also predictive of negative
long-term outcomes for children with ASD. Direct Instruction-Language for Learning (DI-LL) is
a commercially available intervention package that has demonstrated effectiveness in children
with language delays due to disadvantaged backgrounds, learning disabilities, or a primary
language disorder - but it has not been carefully studied in ASD. This study will test the
efficacy of DI-LL in young school-age children with ASD and moderate language delay. DI-LL is
a structured, relatively inexpensive intervention designed to promote a range of language
skills. It offers a comprehensive, carefully sequenced, brisk-paced program designed to teach
a range of language skills to children with language impairments. A key strength of DI-LL is
that it can be implemented by educators, psychologists, speech pathologists, behavior
therapists without requiring deep expertise in behavioral interventions for ASD.

100 participants, ages 4 to 7 years, 11 months, will be randomly assigned to either DI-LL or
Treatment as Usual (TAU). Children randomly assigned to DI-LL will be allowed to continue in
ongoing treatments as well. Forty to 42 treatment sessions will occur across 24 weeks with
post-treatment follow up visits at Weeks 36 and 48 for subjects in DI-LL. Negative responders
to TAU at Week 24 will be offered treatment with DI-LL for 24 weeks. This study is designed
to compare DI-LL and TAU on two standardized tests of language function; overall improvement
rated by a blinded clinician; and the number of spoken words in a structured laboratory
setting via direct observation - again blind to treatment assignment. The intent to treat
approach will be used in efficacy analysis and adverse events will be monitored throughout
the trial.

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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.)