Intervention for Toddlers at Risk for Autism Spectrum Disorders (ASD)

Recruitment & Eligibility

Inclusion Criteria

Children will be ascertained between 11 months and 21 months of age
Must be able to enter the study prior to their second birthday
Must then pass an eligibility assessment to determine whether the child meets criteria for ASD and thus qualifies for the study. This assessment will consist of the Baby ADOS and the Mullen Scales of Early Learning. Children must meet criteria for ASD or autism on the ADOS, score more than one standard deviation below the mean on the Receptive or Expressive Language scale of the MSEL, and have a clinical judgment of ASD to be eligible for enrollment into treatment.
Parents must agree to participate in the study and commit to having their child participate in the intervention to which they are randomized for 6 months
The parent (or other primary caregiver, such as grandparent) in the Parent Enrichment/Training condition must agree to attend the training sessions

Exclusion Criteria

Fail hearing or vision screening (by pediatrician's office, audiologist, or ophthalmologist)
Family's first language being other than English (language measures are normed on English speakers, putting non-English speakers at a disadvantage. In addition, the treatment is delivered in English. Children from non-English speaking homes may not make progress, but for reasons other than the efficacy of the intervention.)
Head injury (because this may cause some of the symptoms, which may not be due to autism and therefore we would not be able to assess the effects of the intervention on autism)
Identified reason for the autism (e.g., fragile X syndrome, Rett syndrome, Tuberous Sclerosis)
Inability of the family to attend the playgroup sessions and parent trainings
Parents whose hearing or vision is not within normal limits after correction (e.g., hearing aid, glasses)
Parents with developmental delays, language or learning impairments, or a psychiatric diagnosis IF the impairment would interfere with parent training (PI will assess on a case by case basis by talking to the parent)
Foster children
Refusal to allow videotaping of the children's assessments or intervention or to allow videotaped footage to be used for teaching purposes.

Study & Design

Arm && Interventions

Group	Intervention	Description
Playgroup and Parent Training	Parent Training	1. One to two-hour individual therapeutic sessions with parent training in the home or clinic, 1x every week over six months; 2. parent training/enrichment once a week in our clinic for 20 sessions at 1-2 hours; 3. a playgroup session for 1-2 hours 2x week for 6 months in our clinic and 4. Community treatment as usual.
Parent Training	Parent Training	1. Parent enrichment sessions once a week for 20 sessions (for 1-2 hours) 2. Community treatment as usual.
Playgroup and Parent Training	Playgroup	1. One to two-hour individual therapeutic sessions with parent training in the home or clinic, 1x every week over six months; 2. parent training/enrichment once a week in our clinic for 20 sessions at 1-2 hours; 3. a playgroup session for 1-2 hours 2x week for 6 months in our clinic and 4. Community treatment as usual.

Primary Outcome Measures

Name	Time	Method
Developmental Level	3 months into treatment, 6 months into treatment, and 6 months after treatment ends	Using the Mullen Scales of Early Learning to assess.

Secondary Outcome Measures

Name	Time	Method
Communication	6 months after treatment ends	Using Communication and Symbolic Behavior Scales to assess.
Presence and Severity of Autism	6 months after treatment ends	Using Autism Diagnostic Observation Schedule to assess.

Recruitment & Eligibility