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Early Connections, Early Detection and Intervention in Infants at Risk for Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00947700
Recruitment Status : Completed
First Posted : July 28, 2009
Last Update Posted : April 20, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

July 24, 2009
July 28, 2009
April 20, 2017
January 2008
June 2013   (Final data collection date for primary outcome measure)
  • Autism Symptoms [ Time Frame: 12 months ]
    AOSI
  • Mullen Receptive Language Scale [ Time Frame: 12 months ]
    Mullen Receptive Language Scale SS
  • Communication and Symbolic Behavior Scale [ Time Frame: 12 months ]
    CSBS Total Composite Score
  • Autism Symptoms [ Time Frame: 12, 18 and 24 months ]
  • Mullen Receptive Language Scale [ Time Frame: 24 months ]
  • Communication and Symbolic Behavior Scale [ Time Frame: 12, 18 and 24 months ]
Complete list of historical versions of study NCT00947700 on ClinicalTrials.gov Archive Site
  • Parent Child Interaction [ Time Frame: 12 months ]
    NCAST Caregiver Total
  • Parent quality of life [ Time Frame: 12 months ]
    Questionnaire on Resources and Stress Total Score
  • Parent Child Interaction [ Time Frame: 12, 18 and 24 m onths ]
  • Parent quality of life [ Time Frame: 12, 18 and 24 months ]
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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Autism Spectrum Disorder
Behavioral: Assessment, Monitoring & Intervention
Assessment and monitoring at 6, 12, 18 and 24 months; Parent delivered intervention provided between 6 and 12 months.
Other Name: Promoting First Relationships
  • No Intervention: Assessment & Monitoring
    No Intervention. Parent-Child participants in assessment and monitoring visits but does not receive any study provided treatment.
  • Experimental: Assessment, Monitoring + Intervention
    Parent-Child participants in assessment and monitoring visits but also the Promoting First Relationships PFR intervention (http://pfrprogram. Org). PFR is a 10 weekly 60-85 minute in-home visits by a masters level mental health provider trained in the PFR curriculum. The PFR curriculum focuses on increasing parenting sensitivity using attachment theory-informed, strength-based consultation strategies. The curriculum is fully manualized and fidelity was assessed according to the manual.
    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.
 
Completed
100
June 2013
June 2013   (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)
Sexes Eligible for Study: All
5 Months to 12 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00947700
32400
P50HD055782 ( U.S. NIH Grant/Contract )
P30ES007033 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Participant level data was submitted to NDAR.
Sara Jane Webb, 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
April 2017

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