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Intervention for Toddlers at Risk for Autism Spectrum Disorders (ASD) - NCT01179841-21211(Clinical Trial 722322)



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City:  Baltimore
State:  
MD
Zip Code: 21211
Conditions: Autism Spectrum Disorder
Purpose: 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 improvement in this intervention, the investigators hope that the availability of public services of this type will be increased. Children between 11 months and 21 months old with Autism Spectrum Disorders, or with social and communication delays that indicate high risk for Autism Spectrum Disorders, and their parents may join the study. Treatment must start prior to the second birthday.
Study summary:
Criteria: 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 is available at: Kennedy Krieger Institute
Baltimore, MD 21211
United States

Primary Contact:
Rebecca Landa, PhD, CCC-SLP
Email: landa@kennedykrieger.org
Phone: 443-923-7551

Secondary Contact:
Rebecca Landa, PhD, CCC-SLP
Email: landa@kennedykrieger.org
Phone: 443-923-7680
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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