Direct Instruction Language for Learning in Autism Spectrum Disorder (NCT02483910) | Clinical Trial Compass
CompletedNot Applicable
Direct Instruction Language for Learning in Autism Spectrum Disorder
United States137 participantsStarted 2015-10
Plain-language 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.
Who can participate
Age range
4 Years – 7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Clinical Evaluation of Language Fundamentals-4 (CELF-4) Score
Timeframe: Baseline, Week 24, Week 48
2
Change in Clinical Evaluation of Language Fundamentals-Preschool 2 (CELF-P) Score