Direct Instruction Language for Learning in Autism Spectrum Disorder
Condition: Autism Spectrum Disorder; Moderate Language Delay
MeSH terms: Language Development Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Direct Instruction-Language for Learning (DI-LL) via telehealth (e.g., Zoom or WebEx); Standard of care delivered via telehealth (e.g., Zoom or WebEx)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): DI-LL is composed of up to 150 lessons (15 sets of 10 lessons each - e.g., lessons 1-10, 11-20, 21-30, etc.) that build on one another. The program uses demonstrations and pictures to expand vocabulary and teach language skills to children in manageable steps. The curriculum focuses on teaching spoken language across six areas: actions, description of objects, general information, standardized prompts ("show me" or "point to" or "say the whole thing"), classification, and problem-solving strategies. For example, DI-LL moves from the identification of familiar objects to the description and classification of these objects. Children learn the precise meaning of both familiar and new concepts and use these concepts in statements and questions. The DI-LL also incorporates 15 assessment tests (one for each set of 10 lessons). These assessment tests are given after each set of 10 lessons to confirm mastery of the material and the child's readiness to move on to the next set of 10 lessons.; Usual care including speech therapy in school, community or both
Other intervention name(s): Due to the shut down imposed by the coronavirus delivery of the intervention is via telehealth (e.g., Zoom or WebEx); Due to the shut down imposed by the coronavirus delivery of the intervention is via telehealth (e.g., Zoom or WebEx)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: School-age children; Pediatrics; Direct Instruction-Language for Learning