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

This study has been completed.
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Sara Jane Webb, University of Washington
ClinicalTrials.gov Identifier:
NCT00947700
First received: July 24, 2009
Last updated: April 18, 2017
Last verified: April 2017
  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 & Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Other
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 Sara Jane Webb, University of Washington:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 100
Study Start Date: January 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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   (Child)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947700

Locations
United States, Washington
Center on Human Development and Disabilities, University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
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
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

Responsible Party: Sara Jane Webb, Associate Professor, Psychiatry and Behavioral Sciences, University of Washington
ClinicalTrials.gov Identifier: NCT00947700     History of Changes
Other Study ID Numbers: 32400
P50HD055782 ( U.S. NIH Grant/Contract )
P30ES007033 ( U.S. NIH Grant/Contract )
Study First Received: July 24, 2009
Last Updated: April 18, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participant level data was submitted to NDAR.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sara Jane Webb, University of Washington:
Infants
Risk markers
ERP
Parent child interaction
Promoting First Relations
Social Communication

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 16, 2017