Clinical trial NCT00947700: Early Connections, Early Detection and Intervention in Infants at Risk for Autism
Official title: UW ACE Project II, Early Detection and Intervention in Infants at Risk for Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Infants
Risk markers
ERP
Parent child interaction
Promoting First Relations
Social Communication
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute of Environmental Health Sciences (NIEHS)
name: Autism Speaks
name: Washington State Department of Social and Health Services
name: Autism Science Foundation
First posted: 2009-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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 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)

Primary outcomes:
measure: Autism Symptoms
timeFrame: 12 months
measure: Mullen Receptive Language Scale
timeFrame: 12 months
measure: Communication and Symbolic Behavior Scale
timeFrame: 12 months
Secondary outcomes:
measure: Parent Child Interaction
timeFrame: 12 months
measure: Parent quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Center on Human Development and Disabilities, University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Bryan King, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Sara J Webb, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Annette Estes, PhD
role: PRINCIPAL_INVESTIGATOR
References: