Clinical trial NCT02483910: Direct Instruction Language for Learning in Autism Spectrum Disorder
Official title: Efficacy of the Direct Instruction Language for Learning Program to Promote Expressive and Receptive Language in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Moderate Language Delay
Keywords: School-age children
Pediatrics
Direct Instruction-Language for Learning
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 137
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Change in the Clinical Evaluation of Language Fundamentals-4 (CELF-4) Score
timeFrame: Baseline, Week 24, Week 48
measure: Change in Clinical Evaluation of Language Fundamentals-Preschool 2 (CELF-P) Score
timeFrame: Baseline, Week 24, Week 48
Secondary outcomes:
measure: Improvement item of the Clinical Global Impression scale (CGI-I)
timeFrame: Baseline, Week 24, Week 48
Other outcomes:
measure: Change in Growth Scale Value score of the Expressive Vocabulary Test-2 (EVT-2)
timeFrame: Baseline, Week 24
measure: Change in Parent-rated Vineland Adaptive Behavior Scales II (Vineland-II)
timeFrame: Baseline, Week 24, Week 48
measure: Change in Parenting Stress Index - Short Form (PSI-SF)
timeFrame: Baseline, Week 24
measure: Change in Caregiver Strain Questionnaire (CGSC)
timeFrame: Baseline, Week 24
Locations:
city: Atlanta
country: United States
facility: Marcus Autism Center - Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Lawrence Scahill, MSN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scahill L, Shillingsburg MA, Ousley O, Pileggi ML, Kilbourne RL, Buckley D, Gillespie SE, McCracken C. A Randomized Trial of Direct Instruction Language for Learning in Children With Autism Spectrum Disorder. J Am Acad Child Adolesc Psychiatry. 2022 Jun;61(6):772-781. doi: 10.1016/j.jaac.2021.11.034. Epub 2022 Jan 31.