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View Clinical Trial (Medical Research Study)
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Social and Communication Outcomes for Young Children With Autism - NCT00953095-21211 (Clinical Trial 304833)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy304833.aspx
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| City: |
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Baltimore |
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State:
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MD |
| Zip Code: |
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21211 |
| Conditions: |
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Autism Spectrum Disorder |
| Purpose: |
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The goal of this project is to test an intervention program for caregivers and their young
children with autism that is focused on improving social communication. This study
specifically targets underserved populations, specifically children from low SES and
racial/ethnic minority families. Participants will include 40 children (aged 24 months to
60 months) and their caregivers who will be randomized (as if by flipping a coin) to one of
the two treatments: Parent education sessions for two hours a week for 12 weeks or
parent-child intervention sessions with the child for one hour, twice a week for 12 weeks.
Young children with autism have difficulty with engaging in joint attention with others
(e.g. pointing, showing. Joint attention skills are important to later development of
language. Therefore, targeting this problem in young children may result in better language
outcomes for these children.
In order to examine the effects of the interventions, all participants will be complete a
play-based pre-treatment assessment, an assessment at the end of the first 12 weeks of the
intervention, and a post-treatment assessment immediately following the intervention
(approximately 2.5 to 3 hours each).
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| Study summary: |
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Child/parent dyads will be randomized to one of two intervention conditions: (1)
Parent-child model, also known as the Caregiver Education Model (CMM):focuses on joint
attention/engagement intervention using an established evidence based treatment (Kasari et
al., 2006). It involves individual interventionist meetings with the parents and their
children in their homes for one hour, twice a week for 12 weeks. In this intervention, the
parent-child pair meet with the interventionist (as opposed to the group training in the CEM
condition). Parents will be specifically taught techniques for altering the home
environment and ways to enhance children's language, social, and play development. Parents
will given guided practice (input and coaching from the interventionist) as they implement
these techniques with their child. (2)Parent-education intervention, also known as the
Caregiver Education Model (CEM): focuses on teaching parents information about autism,
behavior modification, and community services using a manualized approach (Brereton & Tonge,
2005). Parents will receive information on child development each week, and will be able to
ask questions and discuss the information vis-à-vis their own child. This intervention is
manualized (Brereton & Tonge 2005). In the CEM condition, parents meet in a group, without
their children, in a community-based setting to receive the intervention. Intervention in
both conditions occurs once a week for one hour and 15 minute sessions during (12 weeks). |
| Criteria: |
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Inclusion Criteria:
- Children must be between 24 months and 60 months at entry into the study
- Children must have a clinical diagnosis of autism or PDD-NOS, and/or meet criteria on
the ADOS for ASD or autism
- Children must have an age equivalent of 12 months or greater for non-verbal ability
based on the Mullen Visual Reception and Fine Motor scales
- Caregiver and child must be available for all assessments
- Children must be able to walk independently
- Parents must be between the ages of 16 and 50 years old
Exclusion Criteria:
- Children must not have a seizure disorder
- Children must not have associated sensory (uncorrected hearing loss greater than 20
db or vision loss) or physical disorders that restrict mobility (e.g., cerebral
palsy)
- Children must not have sustained a head injury
- Children's diagnosis of autism spectrum disorder must not be comorbid with other
medical syndromes (e.g., Tuberose Sclerosis, Neurofibromatosis, Down syndrome,
fragile X) or diseases
- Children must not be in foster care
- English must be the primary language spoken at home
- Parents must not have a psychiatric diagnosis or a diagnosis of mental retardation |
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| Study is available at: |
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Kennedy Krieger Institute
Baltimore, MD 21211
United States
Primary Contact:
Rebecca Landa, Ph.D., CCC-SLP
Email: Landa@kennedykrieger.org
Phone: 443-923-7551
Secondary Contact:
Connie Kasari, Ph.D.
Email: kasari@gseis.ucla.edu
Phone: 310-825-8342 |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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