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

Study Overview
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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.

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.

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

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Assessment, Monitoring & Intervention


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 5 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Assessment & Monitoring<br>No Intervention. Parent-Child participants in assessment and monitoring visits but does not receive any study provided treatment. | |
| Experimental: Assessment, Monitoring + Intervention<br>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<br>* Assessment and monitoring at 6, 12, 18 and 24 months; Parent delivered intervention provided between 6 and 12 months.<br>* Other names: Promoting First Relationships;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infants, Risk markers, ERP, Parent child interaction, Promoting First Relations, Social Communication