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
Sponsor:
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

July 24, 2009
September 2, 2010
January 2008
July 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00947700 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Early Connections, Early Detection and Intervention in Infants at Risk for Autism
UW ACE Project II, Early Detection and Intervention in Infants at Risk for Autism

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Autism Spectrum Disorder
  • Behavioral: Assessment & Monitoring
    Assessment & monitoring at 6, 12, 18 and 24 months.
  • 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
  • Active Comparator: Assessment & Monitoring
    Intervention: Behavioral: Assessment & Monitoring
  • Experimental: Assessment, Monitoring & Intervention
    Intervention: Behavioral: Assessment, Monitoring & Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
July 2012
July 2012   (final data collection date for primary outcome measure)

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)
Both
5 Months to 12 Months
Yes
Contact: Vanessa Rivera 1-800-994-9701 ddrinfo@u.washington.edu
Contact: Sara Webb, PhD 1-206-221-6461 sjwebb@u.washington.edu
United States
 
NCT00947700
32400-G, NIH P50 HD055782
No
Dr. Bryan H King MD; Professor and Vice Chair, Psychiatry and Behavioral Sciences, University of Washington
University of Washington
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Environmental Health Sciences (NIEHS)
  • Autism Speaks
  • Washington State Department of Social and Health Services
  • Autism Science Foundation
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
University of Washington
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP