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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Assessment & Monitoring

No Intervention. Parent-Child participants in assessment and monitoring visits but does not receive any study provided treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Assessment, Monitoring & Intervention

Intervention Type BEHAVIORAL

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

Interventions

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Assessment, Monitoring & Intervention

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Promoting First Relationships

Eligibility Criteria

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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)

Minimum Eligible Age

5 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes