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Direct Instruction Language for Learning in Autism Spectrum Disorder (DILL ASD)

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ClinicalTrials.gov Identifier: NCT02483910
Recruitment Status : Recruiting
First Posted : June 29, 2015
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Lawrence Scahill, Emory University

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Moderate Language Delay Behavioral: Direct Instruction-Language for Learning (DI-LL) Behavioral: Treatment as Usual Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of the Direct Instruction Language for Learning Program to Promote Expressive and Receptive Language in Children With Autism Spectrum Disorder
Study Start Date : October 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Direct Instruction-Language for Learning
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
Behavioral: Direct Instruction-Language for Learning (DI-LL)
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.

Behavioral: Treatment as Usual
Usual care including speech therapy in school, community or both

Active Comparator: Treatment as Usual

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.

Behavioral: Treatment as Usual
Usual care including speech therapy in school, community or both




Primary Outcome Measures :
  1. Change in the Clinical Evaluation of Language Fundamentals-4 (CELF-4) Score [ Time Frame: Baseline, 24 weeks ]
    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.

  2. Change in Clinical Evaluation of Language Fundamentals-Preschool 2 (CELF-P) Score [ Time Frame: Baseline, 24 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in Growth Scale Value score of the Expressive Vocabulary Test-2 (EVT-2) [ Time Frame: Baseline, 24 weeks ]
    The EVT-2 will be administered to measure expressive vocabulary and word retrieval for Standard American English. The Growth Scale Value (GSV) is used to monitor growth on the EVT. The GSV is a score that tracks vocabulary over time. An increase in vocabulary will result in a higher GSV score.

  2. Improvement item of the Clinical Global Impression scale (CGI-I) [ Time Frame: Baseline, 24 weeks ]
    An independent evaluator, who is blind to treatment assignment, will rate the CGI-I using all available information (e.g. Parent Nominated Problems and parent ratings) to assess overall improvement from baseline. It involves a seven-point scale, from 1 "very much improved" through 4 "no change" and 7 "very much worse." By convention, scores of Much Improved (score of 2) or Very Much Improved (score of 1) are used to define positive response; all other scores result in a classification of negative response.

  3. Change in Direct Observation of Spoken Language (DOSL) [ Time Frame: Baseline, 24 weeks ]
    DOSL incorporates fifteen minute caregiver interactions, which will be recorded on video and scored by a trained clinician, who is blind to treatment assignment. The observations will include a 5-minute parent-directed play session with the participant, a 5-minute participant directed play segment in which the caregiver follows the participant's lead, and a 5-minute clean-up segment in which the caregiver directs the participant to put toys away. A standard set of materials including books, blocks, and figurines will be provided so that families have access to similar items. The caregiver-child interactions are based on the Dyadic Parent-Child Interaction Coding System. In addition to the behaviors described in the DPICS manual, the current study will include the number of spoken words including spontaneously spoken words, echoed words, spontaneous requests or requests after parental prompt across time.

  4. Change in Parent-nominated Language Problems (PLPs) [ Time Frame: Baseline, 24 weeks ]
    Parents will be asked to describe the participant's one or two most important language or related problems. Through brief discussion the independent evaluator and the parent will co-construct a narrative to characterize each problem in behavioral terms. Narratives typically include: constancy (some of the time, most of the time, all of the time); impact on the child (avoids social interaction, retreats to socially isolated activity, gets frustrated with inability to communicate); impact of the family (family avoids social interactions, tension between parents on how to manage the problem). The baseline narrative and subsequent revisions will be used in real time to rate the CGI-I and at the end of the study on a 9-point scale by a panel of judges blind to treatment assignment.

  5. Change in Parent-rated Vineland Adaptive Behavior Scales II (Vineland-II) [ Time Frame: Baseline, 24 weeks ]
    Vineland-II is a measure of adaptive skills in every day life. Scores may range from 20-160 with an average of 100 with a standard deviation of 15. Higher scores indicate better adaptive functioning.

  6. Change in Clinician-rated Children's Yale-Brown Obsessive-Compulsive Scales-Autism Spectrum Disorder (CYBOCS-ASD) [ Time Frame: Baseline, 24 weeks ]
    The CYBOCS-ASD is a semi-structured clinician-rated scale designed to rate the current severity of repetitive behavior in children with autism spectrum disorder (ASD). Once the current repetitive behaviors are identified, they are rated on: Time Spent, Interference, Distress, Resistance, and Control. Each of these items is scored from 0 (least symptomatic) to 4 (most symptomatic), yielding a Total score from 0 to 20. Higher scores indicate higher severity.

  7. Change in Parenting Stress Index - Short Form (PSI-SF) [ Time Frame: Baseline, 24 weeks ]
    The PSI-SF is a parent-report questionnaire of parental stress, parent-child interaction style, and difficult child behaviour that will be used to measure changes in parental stress. It is a 36-item questionnaire for families of children 12 years of age and younger. Each of these items is scored using the following 5-point scale: 1 (strongly agree) to 5 (strongly disagree). The total stress score is a composite of the three subscales. Higher scores indicate higher parental stress.

  8. Change in Caregiver Strain Questionnaire (CGSC) [ Time Frame: Baseline, 24 weeks ]
    The CGSC measures the impact of having a child with ASD on the family. The questionnaire includes 21 items that assess three dimensions of caregiver strain: objective strain, internalized subjective strain, and externalized subjective strain. Each item is rated on a 5-point scale ranging from 1(not at all a problem) to 5 (very much a problem). The total score can range from a minimum of 0 - no strain at all, to 110 all items rated as very much.

  9. Parent Satisfaction Survey [ Time Frame: 24 weeks ]
    Parent satisfaction survey will be administered at the end of the treatment period. It is a 13-item parent satisfaction survey and each item is scored using the following 6-point scale: 1 (strongly disagree) to 6 (strongly agree). Total scores are reported with a minimum of 6 and a maximum of 78, with higher scores indicating higher satisfaction.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483910


Contacts
Contact: Marc Badura, MS 404-785-9467 Marc.Badura@choa.org
Contact: Medina Bello, BA 404-785-0328 medina.bello@choa.org

Locations
United States, Georgia
Marcus Autism Center - Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30329
Contact: Crystal Bowen, MS    404-785-9457    crystal.bowen@choa.org   
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Lawrence Scahill, MSN, PhD Emory University

Responsible Party: Lawrence Scahill, Professor of Pediatrics, Emory University
ClinicalTrials.gov Identifier: NCT02483910     History of Changes
Other Study ID Numbers: IRB00081144
AR140208 ( Other Identifier: CDMRP )
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017

Keywords provided by Lawrence Scahill, Emory University:
School-age children
Pediatrics
Direct Instruction-Language for Learning

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Language Development Disorders
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms