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

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Behavioral: Assessment, Monitoring & Intervention

• Registration Number: NCT00947700
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-27
• Study First Posted: 2009-07-28
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Assessment, Monitoring + Intervention	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.

Primary Outcome Measures

Name	Time	Method
Autism Symptoms	12 months	AOSI
Mullen Receptive Language Scale	12 months	Mullen Receptive Language Scale SS
Communication and Symbolic Behavior Scale	12 months	CSBS Total Composite Score

Secondary Outcome Measures

Name	Time	Method
Parent Child Interaction	12 months	NCAST Caregiver Total
Parent quality of life	12 months	Questionnaire on Resources and Stress Total Score

Trial Locations

Locations (1)

Center on Human Development and Disabilities, University of Washington; 🇺🇸 Seattle, Washington, United States