Autism Spectrum DisorderDILLASDNCT02483910
Direct Instruction Language for Learning in Autism Spectrum Disorder
A study testing Direct Instruction-Language for Learning (DI-LL) via telehealth (e.g., Zoom or WebEx) in people with Autism Spectrum Disorder and Moderate Language Delay, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Autism Spectrum Disorder, Moderate Language Delay
- What is being tested?
- Direct Instruction-Language for Learning (DI-LL) via telehealth (e.g., Zoom or WebEx)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 24 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Marcus Autism Center - Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
About this study
Official title: Efficacy of the Direct Instruction Language for Learning Program to Promote Expressive and Receptive Language in Children With Autism Spectrum Disorder
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Moderate Language Delay
- Being tested
- 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)
- Keywords
- School-age children, Pediatrics, Direct Instruction-Language for Learning
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Instruction-Language for Learning (DI-LL) via telehealth (e.g., Zoom or WebEx)Behavioural
Also called Due to the shut down imposed by the coronavirus delivery of the intervention is via telehealth (e.g., Zoom or WebEx)
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.
Standard of care delivered via telehealth (e.g., Zoom or WebEx)Behavioural
Also called Due to the shut down imposed by the coronavirus delivery of the intervention is via telehealth (e.g., Zoom or WebEx)
Usual care including speech therapy in school, community or both
| Study group | Role | What they receive |
|---|---|---|
| DI-LL via telehealth | Experimental | 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 Receives: Behavioral: Direct Instruction-Language for Learning (DI-LL) via telehealth (e.g., Zoom or WebEx); Behavioral: Standard of care delivered via telehealth (e.g., Zoom or WebEx) |
| Standard of care delivered via telehealth | Active comparator | 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. Receives: Behavioral: Standard of care delivered via telehealth (e.g., Zoom or WebEx) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 24, Week 48
Secondary outcomes (1)
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.
Measured: Baseline, Week 24, Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startOct 2015
- Primary completion24 Nov 2020
- Study completion24 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence Scahill, MSN, PhD, Emory University
- Investigators
- Lawrence Scahill, MSN, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483910
- Sponsor's protocol ID
- IRB00081144
- Other IDs
- AR140208
- Acronym
- DILLASD
- Status last verified
- Jan 2021
- First submitted
- 25 Jun 2015
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35093490
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Direct Instruction Language for Learning Program to Promote Expressive and Receptive Language in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT02483910
- Acronym / sponsor ID
- DILLASD / IRB00081144
- Conditions
- Autism Spectrum Disorder, Moderate Language Delay
- Keywords
- School-age children, Pediatrics, Direct Instruction-Language for Learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 24 Nov 2020 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DI-LL via telehealth | Experimental | Behavioral: Direct Instruction-Language for Learning (DI-LL) via telehealth (e.g., Zoom or WebEx), Behavioral: Standard of care delivered via telehealth (e.g., Zoom or WebEx)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 |
| Standard of care delivered via telehealth | Active comparator | Behavioral: Standard of care delivered via telehealth (e.g., Zoom or WebEx)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. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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:
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Instruction-Language for Learning (DI-LL) via telehealth (e.g., Zoom or WebEx)Also: Due to the shut down imposed by the coronavirus delivery of the intervention is via telehealth (e.g., Zoom or WebEx)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. | Behavioural | DI-LL via telehealth |
| Standard of care delivered via telehealth (e.g., Zoom or WebEx)Also: Due to the shut down imposed by the coronavirus delivery of the intervention is via telehealth (e.g., Zoom or WebEx)Usual care including speech therapy in school, community or both | Behavioural | DI-LL via telehealth, Standard of care delivered via telehealth |
Primary outcome
Change in the Clinical Evaluation of Language Fundamentals-4 (CELF-4) Score
Time frame: Baseline, Week 24, Week 48
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
Time frame: Baseline, Week 24, Week 48
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.
1 secondary outcome
Improvement item of the Clinical Global Impression scale (CGI-I)
Time frame: Baseline, Week 24, Week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Derived from this study: PubMed 35093490Scahill 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Scahill, MSN, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Instruction-Language for Learning (DI-LL) via telehealth (e.g., Zoom or WebEx) in people with Autism Spectrum Disorder and Moderate Language Delay, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Clinical Evaluation of Language Fundamentals-4 (CELF-4) Score (time frame: Baseline, Week 24, Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02483910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.