Early Intervention for Minority and Underserved Toddlers With Autism Spectrum Disorder (ASD) - NCT01008800-21211 (Clinical Trial 399714)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy399714.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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This research is being done to test the effectiveness of two treatments aimed at increasing
language and social skills in children with autism spectrum disorder. If children show
improvement in these treatments, we hope that the availability of public services for
minority and low income families will be increased. Minority and low income families with
children between 22 and 33 months of age with Autism Spectrum Disorders may join.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Participants must be 22 to 33 months old
- Children must meet criteria for ASD or autism on the ADOS plus receive a clinical
judgment of PDD-NOS or autism by the study team
- Children must have an age equivalent of 8 months or greater for non-verbal ability
based on the Mullen Visual Reception and Fine Motor scales
- 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-Mediated
condition must agree to attend the training sessions three times per month
- Parents must be between the ages of 16 and 50 years old
- Families who qualify for medical assistance and/or have racial/ethnic minority
backgrounds will be prioritized for recruitment and participation in this study. On
the TSI, we will ask participants if they qualify for medical assistance or if they
are of a racial minority or have a first degree relative of a racial minority.
Families who do not fit these criteria will be notified that they may be eligible to
participate if additional space is available.
- It is not required that English be their primary language, but they must be fluent in
English (or if the child is nonverbal he/she must hear English most of the time at
home)
Exclusion Criteria:
- Head injury prior to enrollment in the study
- Major hearing or visual impairment after correction
- Non-febrile seizures
- PKU (Phenylketonuria)
- Congenital Rubella (German measles)
- Neurofibromatosis
- Tuberous Sclerosis
- Fragile X
- A fall resulting in a loss of consciousness or other severe head injury
- Velo-Cardio Facial Syndrome
- Any other known genetic syndrome
- No foster children may participate
- The child must not be adopted |
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| Study is available at: |
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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
Phone: 443-923-7551 |
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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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