Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Controlled Trial of the P.L.A.Y. Project Intervention for Autism
Brief 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.


Options:
A: Inclusion Criteria for Autistic Participants:

* Diagnosis of autism

Inclusion Criteria for Developmentally Delayed Participants:

* Exhibiting current delays in development

Inclusion Criteria for Participants with Normal Development:

* Exhibiting normal development

Inclusion Criteria for All Participants:

* Overall good health
B: Inclusion Criteria:

* Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview - Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS), Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), and expert clinical opinion
* Outpatients between 2.0 and 6 years of age of either gender
* Children of all cognitive levels will be included as long as they are able to participate in the testing procedures to the extent that valid standard scores can be obtained
* Language delay as measured by the Preschool Language Scale 4th ed. (PLS-4)
* Participants must have the ability to make meaningful vocalizations, defined as the ability to make contingent vocalizations when prompted (i.e., vocal sound showing intent to communicate, but not necessarily clear words)
* Stable psychotropic medication(s) or biomedical interventions for at least one month prior to baseline measurements with no anticipated changes during study participation
* Stable behavioral treatment (Applied Behavioral Analysis, Floortime, or other interventions), speech therapy, and school placement for at least 2 months prior to baseline measurements with no expected changes during study participation
* No more than 60 minutes of 1:1 speech therapy per week
* The availability of at least one parent who can consistently participate in the group treatment and related activities of the research study
* Be male or female in good medical health
* Will be starting PRTG after the first magnetic resonance image (MRI) scan has occured and, if agreeable, blood draw or saliva sample
* Parents intend on continuing PRTG for a minimum of 12 weeks
* Parents must be 18 years of age or older.

Exclusion Criteria:

* A current or life-time diagnosis of severe psychiatric disorder (e.g., bipolar disorder...)
* A genetic abnormality, such as Fragile X, based on genetic testing, done as indicated
* Presence of active medical problem (e.g., unstable seizure disorder or heart disease)
* Participants taking psychotropic medications will not be included if their medications have not been stable for over a week
* Parents who do not have the ability to videotape parent and child interactions on a weekly basis
* Parents who are not willing to implement intervention strategies for at least one hour a day
* Parents who plan to alternate which parent attends the group sessions.
C: Inclusion Criteria: Children ages 3-5 years 11 months old diagnosed with autism.

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Exclusion Criteria:

We excluded children if they had been diagnosed with Asperger's Syndrome, had identifiable genetic disorders, severe medical conditions, a parent with severe psychiatric disorder or cognitive impairment, and/or families who did not speak English with their child. Families in the CS group who reported receiving intensive intervention (\>10 hours/week of a programmatic approach to ASD-check this) were excluded from the study.

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D: Inclusion Criteria:

* Diagnosis of autism from a licensed psychologist or board certified developmental pediatrician, or child and adolescent psychiatrist, confirmed by Module 1 of the Autism Diagnostic Observation Schedule (Lord et al., 2001)
* Chronological age between 5 and 8 years
* Classified as nonverbal with fewer than 20 spontaneous expressive words as determined by parent report, language sample, and standardized tests.
* Demonstrated slow or no progress in expressive language acquisition despite at least 2 years of early intervention

Exclusion Criteria:

* Major medical conditions other than autism, specifically: a) motor disabilities such as cerebral palsy or tuberous sclerosis, b) sensory disabilities such as blindness or deafness, and c) genetic disorders such as Fragile X or Down syndrome.
* Nonverbal mental age \< 24 months, based on a nonverbal score from the Leiter-R (Roid \& Miller, 1997).

Answer: C