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Direct Instruction Language for Learning in Autism Spectrum Disorder (DILLASD)

Primary Purpose

Autism Spectrum Disorder, Moderate Language Delay

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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)

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring School-age children, Pediatrics, Direct Instruction-Language for Learning

Eligibility Criteria

4 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

Marcus Autism Center - Children's Healthcare of Atlanta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DI-LL via telehealth

Standard of care delivered via telehealth

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Improvement item of the Clinical Global Impression scale (CGI-I)

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.

Full Information

NCT ID

NCT02483910

First Posted

June 25, 2015

Last Updated

January 4, 2021

Sponsor

Emory University

1. Study Identification

Unique Protocol Identification Number

NCT02483910

Brief Title

Direct Instruction Language for Learning in Autism Spectrum Disorder

Acronym

DILLASD

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

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

October 2015 (Actual)

Primary Completion Date

November 24, 2020 (Actual)

Study Completion Date

November 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder, Moderate Language Delay

Keywords

School-age children, Pediatrics, Direct Instruction-Language for Learning

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

137 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DI-LL via telehealth

Arm Type

Experimental

Arm Description

Arm Title

Standard of care delivered via telehealth

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Direct Instruction-Language for Learning (DI-LL) via telehealth (e.g., Zoom or WebEx)

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)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Standard of care delivered via telehealth (e.g., Zoom or WebEx)

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)

Intervention Description

Usual care including speech therapy in school, community or both

Primary Outcome Measure Information:

Title

Change in the Clinical Evaluation of Language Fundamentals-4 (CELF-4) Score

Description

Time Frame

Baseline, Week 24, Week 48

Title

Change in Clinical Evaluation of Language Fundamentals-Preschool 2 (CELF-P) Score

Description

Time Frame

Baseline, Week 24, Week 48

Secondary Outcome Measure Information:

Title

Improvement item of the Clinical Global Impression scale (CGI-I)

Description

Time Frame

Baseline, Week 24, Week 48

Other Pre-specified Outcome Measures:

Title

Change in Growth Scale Value score of the Expressive Vocabulary Test-2 (EVT-2)

Description

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.

Time Frame

Baseline, Week 24

Title

Change in Parent-rated Vineland Adaptive Behavior Scales II (Vineland-II)

Description

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.

Time Frame

Baseline, Week 24, Week 48

Title

Change in Parenting Stress Index - Short Form (PSI-SF)

Description

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.

Time Frame

Baseline, Week 24

Title

Change in Caregiver Strain Questionnaire (CGSC)

Description

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.

Time Frame

Baseline, Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

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.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lawrence Scahill, MSN, PhD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Marcus Autism Center - Children's Healthcare of Atlanta

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30329

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35093490

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.

Results Reference

derived

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Direct Instruction Language for Learning in Autism Spectrum Disorder

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