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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00947700
Enrollment
100
Registered
2009-07-28
Start date
2008-01-31
Completion date
2013-06-30
Last updated
2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Infants, Risk markers, ERP, Parent child interaction, Promoting First Relations, Social Communication

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.

Interventions

BEHAVIORALAssessment, Monitoring & Intervention

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Months to 12 Months
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Autism Symptoms12 monthsAOSI
Mullen Receptive Language Scale12 monthsMullen Receptive Language Scale SS
Communication and Symbolic Behavior Scale12 monthsCSBS Total Composite Score

Secondary

MeasureTime frameDescription
Parent Child Interaction12 monthsNCAST Caregiver Total
Parent quality of life12 monthsQuestionnaire on Resources and Stress Total Score

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026