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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947700
• Other study ID #: 32400
• Secondary ID: P50HD055782P30ES
• Status: Completed
• Phase: N/A
• First received: July 24, 2009
• Last updated: April 18, 2017
• Start date: January 2008
• Est. completion date: June 2013

Study information

• Verified date: April 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Months to 12 Months

Eligibility

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)

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• Assessment, Monitoring & Intervention
Assessment and monitoring at 6, 12, 18 and 24 months; Parent delivered intervention provided between 6 and 12 months.

Locations

Country	Name	City	State
United States	Center on Human Development and Disabilities, University of Washington	Seattle	Washington

Sponsors (6)

Lead Sponsor	Collaborator
University of Washington	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autism Symptoms	AOSI	12 months
Primary	Mullen Receptive Language Scale	Mullen Receptive Language Scale SS	12 months
Primary	Communication and Symbolic Behavior Scale	CSBS Total Composite Score	12 months
Secondary	Parent Child Interaction	NCAST Caregiver Total	12 months
Secondary	Parent quality of life	Questionnaire on Resources and Stress Total Score	12 months