Early Connections, Early Detection and Intervention in Infants at Risk for Autism
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Washington.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Washington
Collaborators:
Autism Speaks
Washington State Department of Social and Health Services
Autism Science Foundation
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00947700
First received: July 24, 2009
Last updated: September 2, 2010
Last verified: September 2010
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Purpose
Early connections has two broad goals:
- to identify risk indices for autism spectrum disorder (ASD) in 6 to 24 month old infants who have an older sibling with ASD or infants who have an older neurotypical sibling.
- to assess whether it is possible to alter risk processes through early intervention with high-risk infants, thereby reducing social-communication delays or the severity of autism symptoms.
| Condition | Intervention |
|---|---|
|
Autism Spectrum Disorder |
Behavioral: Assessment & Monitoring Behavioral: Assessment, Monitoring & Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
| Official Title: | UW ACE Project II, Early Detection and Intervention in Infants at Risk for Autism |
Resource links provided by NLM:
Further study details as provided by University of Washington:
Primary Outcome Measures:
- Autism Symptoms [ Time Frame: 12, 18 and 24 months ] [ Designated as safety issue: No ]
- Mullen Receptive Language Scale [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Communication and Symbolic Behavior Scale [ Time Frame: 12, 18 and 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Parent Child Interaction [ Time Frame: 12, 18 and 24 m onths ] [ Designated as safety issue: No ]
- Parent quality of life [ Time Frame: 12, 18 and 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Assessment & Monitoring |
Behavioral: Assessment & Monitoring
Assessment & monitoring at 6, 12, 18 and 24 months.
|
| Experimental: Assessment, Monitoring & Intervention |
Behavioral: Assessment, Monitoring & Intervention
Assessment and monitoring at 6, 12, 18 and 24 months; Parent delivered intervention provided between 6 and 12 months; and 12 and 18 months based on symptom severity
|
Detailed Description:
Researchers at the University of Washington want to learn more about the benefits of early monitoring and intervention for younger siblings of children with autism spectrum disorders (ASD). The information gained in this study may improve methods of early detection and intervention for infants who may be at risk for developing autism and lead to better outcome for these young children and their families.
Participants include families with a child who has been diagnosed with an autism spectrum disorder or typical development and a younger sibling 12 months old or younger. The study protocol includes: (1) comprehensive infant evaluations at the University of Washington Autism Center at 6-months, 12-months, 18-months and 24-months of age. (2) Developmental screening for the older sibling. (3) Questionnaires and phone interviews for parents. (4) Random assignment to an assessment and monitoring intervention group or a University of Washington intervention group. All families will receive advice regarding appropriate intervention services. Families who are assigned to the UW intervention will take part in a parent delivered intervention.
Eligibility| Ages Eligible for Study: | 5 Months to 12 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Older sibling with ASD (biologically related to participant)
- Participant 12 months of age or younger
- Within 1 hour of University of Washington
- Interested in participating in Intervention
Exclusion Criteria:
- Out of study area
- Serious parent substance abuse or psychiatric history
- Diagnosis of known genetic syndromes or neurological conditions (infant participant or older sibling)
- Serious motor impairment (infant participant)
- Significant prematurity (infant participant)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947700
Contacts
| Contact: Vanessa Rivera | 1-800-994-9701 | ddrinfo@u.washington.edu |
| Contact: Sara Webb, PhD | 1-206-221-6461 | sjwebb@u.washington.edu |
Locations
| United States, Washington | |
| Center on Human Development and Disabilities, University of Washington | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: Sara J Webb, PhD | |
| Principal Investigator: Annette Estes, PhD | |
Sponsors and Collaborators
University of Washington
Autism Speaks
Washington State Department of Social and Health Services
Autism Science Foundation
Investigators
| Principal Investigator: | Bryan King, MD | University of Washington |
| Principal Investigator: | Sara J Webb, PhD | University of Washington |
| Principal Investigator: | Annette Estes, PhD | University of Washington |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Bryan H King MD; Professor and Vice Chair, Psychiatry and Behavioral Sciences, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00947700 History of Changes |
| Other Study ID Numbers: | 32400-G, NIH P50 HD055782 |
| Study First Received: | July 24, 2009 |
| Last Updated: | September 2, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Washington:
|
Infants Risk markers ERP |
Parent child interaction Promoting First Relations Social Communication |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013