Status:
COMPLETED
Intervention for Toddlers at Risk for Autism Spectrum Disorders (ASD)
Lead Sponsor:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborating Sponsors:
Autism Speaks
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
11-21 years
Phase:
NA
Brief Summary
This research is being done to test the effectiveness of an early intervention model for very young children at high risk for autism spectrum disorders (ASD) and their families. If children show impro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01179841
Start Date
January 1 2008
End Date
December 1 2011
Last Update
March 10 2021
Active Locations (1)
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1
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21211