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NCT01768806 · ClinicalTrials.gov registry record · NA
Randomized Controlled Trial of the P.L.A.Y. (Play and Language for Autistic Youngsters) Project Intervention for Autism
A NA study of Autism Spectrum Disorder and Autism, sponsored by Richard Solomon MD.
- Completed
- Registry status
- NA
- Development phase
- 112
- Enrollment target
- 1
- Study location
NCT01768806: Completed NA study of Autism Spectrum Disorder and Autism, sponsored by Richard Solomon MD.
NCT01768806 is a NA study of Autism Spectrum Disorder and Autism that has completed, run by Richard Solomon MD. The registered enrollment target is 112 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (17% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01768806, a NA study of Autism Spectrum Disorder and Autism, has completed, sponsored by Richard Solomon MD.
- COMPLETED
- Registry status
- NA
- Development phase
- 112 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a large, multi-site, randomized controlled NIH trial that evaluates whether The P.L.A.Y. (Play and Language for Autistic Youngsters) Project is effective. The PLAY Project Home Consultation model coaches parents, through monthly home visits and the use of video feedback, to effectively interact with their young child with autism. The aims of the study are 1.) to show that the PLAY Home Consultants show fidelity to the model, 2.) that caregivers can be taught to interact in an engaging way with their child (with causing more stress), 3.) that the child then interacts better, improves his/her language, and has reduced severity of his or her autism.
Primary Outcome
Autism Diagnostic Observation Scale (ADOS) (Lord ) yields scores in 3 scales: Communication, Social Interaction, and Circumscribed Interests. The ADOS has been repeatedly evaluated as diagnostic measures, it has also been used as an outcome measure of autism severity (Aldred et al., 2004; Gutstein, 2007; Owly et al, 2001, Green et al, 2010). The ADOS distinguishes three levels of severity: Autism, Autistic Spectrum Disorder, and non-autistic. Pre- and post-assessment using the ADOS will be used
Conditions Studied
Interventions
- BEHAVIORAL PLAY Project Intervention for Autism
- BEHAVIORAL Special education pre-school
Study Locations (1)
Michigan
- Ann Arbor Center for Developmental and Behavioral Pediatrics - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-12 |
| Phase | NA |
What the finished NCT01768806 record still lists
NCT01768806 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (17% lower).
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which PLAY Project Intervention for Autism is the first listed.
NCT01768806 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT01768806 about?
NCT01768806 is a clinical study titled "Randomized Controlled Trial of the P.L.A.Y. (Play and Language for Autistic Youngsters) Project Intervention for Autism". This study is a large, multi-site, randomized controlled NIH trial that evaluates whether The P.L.A.Y. (Play and Language for Autistic Youngsters) Project is effective. The PLAY Project Home Consultation model coaches parents, through monthly home visits and the use of video feedback, to effectively...
What is the current status of trial NCT01768806?
This trial is currently completed. It is a NA study. The enrollment target is 112 participants. The study started on 2009-09. Estimated completion is 2012-12.
What conditions does trial NCT01768806 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Autism.
What interventions are being tested in trial NCT01768806?
The interventions under investigation include: PLAY Project Intervention for Autism (BEHAVIORAL), Special education pre-school (BEHAVIORAL).
Who is sponsoring clinical trial NCT01768806?
This trial is sponsored by Richard Solomon MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01768806 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01768806's enrollment target sits among peer trials
112 68th of 224 higher than 157 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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