Early Connections, Early Detection and Intervention in Infants at Risk for Autism
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00947700|
Recruitment Status : Completed
First Posted : July 28, 2009
Last Update Posted : April 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: Assessment, Monitoring & Intervention||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||UW ACE Project II, Early Detection and Intervention in Infants at Risk for Autism|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
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 Name: Promoting First Relationships
- Autism Symptoms [ Time Frame: 12 months ]AOSI
- Mullen Receptive Language Scale [ Time Frame: 12 months ]Mullen Receptive Language Scale SS
- Communication and Symbolic Behavior Scale [ Time Frame: 12 months ]CSBS Total Composite Score
- Parent Child Interaction [ Time Frame: 12 months ]NCAST Caregiver Total
- Parent quality of life [ Time Frame: 12 months ]Questionnaire on Resources and Stress Total Score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947700
|United States, Washington|
|Center on Human Development and Disabilities, University of Washington|
|Seattle, Washington, United States, 98195|
|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|