DILLASD
Efficacy of the Direct Instruction Language for Learning Program to Promote Expressive and Receptive Language in Children With Autism Spectrum Disorder
Sponsor study identifier
Secondary identifiers
OTHER · CDMRP
interventional
137
1 country
1
Study Start
October 2015
Actual (reported)Primary Completion
November 24, 2020
Actual (reported)Study Completion
November 24, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 24, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 25, 2015
Actual (reported)June 29, 2015
Actual (reported)October 2015
Actual (reported)November 24, 2020
Actual (reported)November 24, 2020
Actual (reported)Change in the Clinical Evaluation of Language Fundamentals-4 (CELF-4) Score
The CELF-4 English Version will be administered to assess the participant's (aged 5-8 years) receptive and expressive language skills.The Core Language score quantifies a participant's overall language performance. The standard score for the Core Language scale is based on a mean of 100 with a standard deviation of 15 (average range of 85-115). The higher the score, the better the language function of the participant.
Baseline, Week 24, Week 48
Change in Clinical Evaluation of Language Fundamentals-Preschool 2 (CELF-P) Score
The CELF-P English Version will be administered to assess the preschool-aged participant's receptive and expressive language skills.The Core Language score quantifies a participant's overall language performance. The standard score for the Core Language scale is based on a mean of 100 with a standard deviation of 15 (average range of 85-115). The higher the score, the better the language function of the participant.
Baseline, Week 24, Week 48
Improvement item of the Clinical Global Impression scale (CGI-I)
Baseline, Week 24, Week 48
Change in Growth Scale Value score of the Expressive Vocabulary Test-2 (EVT-2)
Baseline, Week 24
Change in Parent-rated Vineland Adaptive Behavior Scales II (Vineland-II)
Baseline, Week 24, Week 48
Change in Parenting Stress Index - Short Form (PSI-SF)
Baseline, Week 24
Subjects with autism spectrum disorder (ASD) plus moderate language between 4 years and 7 years 11 months will be randomly assigned to receive Direct Instruction-Language for Learning (DI-LL) for 40-48 sessions (roughly twice a week for 24 weeks). Subjects in this arm will be allowed to continue ongoing treatment during the randomized phase of the study
Subjects with (ASD) plus moderate language between 4 years and 7 years 11 months will be randomly assigned to continue treatment as usual (TAU) for 24 weeks. NOTE: after the randomized trial, subjects who do not show a positive response at Week 24, will be offered Direct Instruction-Language for Learning (DI-LL) for 24 weeks.
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.
Marcus Autism Center - Children's Healthcare of Atlanta
Atlanta, Georgia, 30329, United States
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.
Lawrence Scahill, MSN, PhD
Emory University
137 participants (actual enrollment reported by the registry).
First Submitted
June 25, 2015
First Posted
June 29, 2015
Study Start
October 2015
Actual (reported)Emergence of Generative Language
Usual care including speech therapy in school, community or both
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 24, 2020
Actual (reported)Study Completion
November 24, 2020
Actual (reported)Last Updated
January 6, 2021
Record last verified: 2021-01
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Source: ClinicalTrials.gov.
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