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OpenTrials
Completed

NCT Number: NCT00947700

Early Connections, 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.

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Key information

Conditions

Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Communication Mental Disorders Neurodevelopmental Disorders

Age range

5 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center on Human Development and Disabilities, University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Assessment, Monitoring & Intervention

Behavioral

Assessment and monitoring at 6, 12, 18 and 24 months; Parent delivered intervention provided between 6 and 12 months.

Other names: Promoting First Relationships

Primary outcomes

  1. Autism Symptoms

    Time frame: 12 months

    AOSI

  2. Mullen Receptive Language Scale

    Time frame: 12 months

    Mullen Receptive Language Scale SS

  3. Communication and Symbolic Behavior Scale

    Time frame: 12 months

    CSBS Total Composite Score

Secondary outcomes

  1. Parent Child Interaction

    Time frame: 12 months

    NCAST Caregiver Total

  2. Parent quality of life

    Time frame: 12 months

    Questionnaire on Resources and Stress Total Score

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Autism Science Foundation
  • Autism Speaks
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Environmental Health Sciences (NIEHS)
  • Washington State Department of Social and Health Services

Registry information

Official study title

UW ACE Project II, Early Detection and Intervention in Infants at Risk for Autism

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jul 28, 2009
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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