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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Assessment, Monitoring & Intervention

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Center on Human Development and Disabilities, University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Promoting First Relationships

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autism Symptoms	AOSI	12 months
Mullen Receptive Language Scale	Mullen Receptive Language Scale SS	12 months
Communication and Symbolic Behavior Scale	CSBS Total Composite Score	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Child Interaction	NCAST Caregiver Total	12 months
Parent quality of life	Questionnaire on Resources and Stress Total Score	12 months

Collaborators and Investigators

• Sponsor: University of Washington
• 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
• 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

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: July 24, 2009
• First Submitted That Met QC Criteria: July 27, 2009
• First Posted (Estimate): July 28, 2009

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Social Communication; Infants; ERP; Risk markers; Parent child interaction; Promoting First Relations
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: 32400; P30ES007033 (U.S. NIH Grant/Contract); P50HD055782 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant level data was submitted to NDAR.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No