Please select the eligibility criteria that correspond to the clinical trial below.
Title: Developmental and Augmented Intervention for Facilitating Expressive Language
Brief Summary: This study will contrast two experimental treatment conditions by testing whether joint attention/joint engagement intervention using spoken communication (JAE-EMT) results in better outcomes than joint attention/joint engagement intervention that is instead supplemented with an individualized AAC system (JAE-AAC). Thus, the skills of joint attention/joint engagement (JAE) remain foundational to developing expressive language but the difference in the two treatments will be between whether the JAE is administered through the more traditional spoken means (EMT) or through an augmentative and alternative communication device (AAC).


Options:
A: 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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B: * INCLUSION CRITERIA:
* There are 3 participant groups in this study.

  * AUT: Children with autism (diagnosed with autistic disorder according to DSM-IV criteria). This group will include children that may be dichotomized as with regression and without regression.
  * DD: Children with nonspectrum developmental delays
  * TYP: Children deemed to be typically developing
  * Accrual numbers are to include 140 children in the AUT group, 50 children in the DD group and 75 children in the TYP group.
* AUT: Children are included if they meet DSM-IV criteria for autistic disorder, based on ADI-R and ADOS and clinical judgment. Those meeting research criteria for autism will be included.
* Regression is defined as: Language loss: Loss of at least 3 spontaneously meaningful words (excluding mama or dada) used for at least a month, and lost for at least a month.AND/OR Nonverbal communication/social loss: Loss of more than one nonverbal communicative behavior (e.g. gestures, joint attention, eye contact, imagination, pretend play, sharing, showing, watching children, orienting to name, social smiling, social games, spontaneous imitation of actions, response to social overtures). Although there is overlap in the age period for regression specified in this protocol (regression between 15-30 months) and that described for childhood disintegrative disorder (CDD) (the DSM-IV criteria for indicate apparently normal development for the first 2 years after birth ), the criteria for CDD also indicate a diagnosis can only be made if symptoms are not better accounted for by another pervasive developmental disorder such as autism. Symptoms of CDD that separate it from autism include loss of acquired skills in areas such as motor skills and bowel or bladder control, while the focus of the current study is on regression in core symptoms of autism (i.e. socio-communicative skills). Thus, the currently protocol will include children with regression over 2 who meet criteria for autism, but not those who only meet criteria for CDD.
* DD: Developmental scores (Performance Quotient and Verbal Quotient) greater than 1.5 standard deviations below mean on Mullen Scales of Early Learning
* TYP: No diagnosis of developmental delay, and no first-degree relatives with a history of autism spectrum disorders.

EXCLUSION CRITERIA:

* Diagnosis of cerebral palsy. For the typical controls only, a history of extremely low birth weight (due to prematurity or intrauterine growth failure).
* If behavioral management issues (e.g. self-injury, aggressiveness) are severe to the extent that the screening protocol was aborted.
C: 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).
D: 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.

Answer: C