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

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Assessment, Monitoring & Intervention
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autism Spectrum Disorder focused on measuring Infants, Risk markers, ERP, Parent child interaction, Promoting First Relations, Social Communication

Eligibility Criteria

5 Months - 12 Months (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Center on Human Development and Disabilities, University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Assessment & Monitoring

Assessment, Monitoring + Intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Autism Symptoms
AOSI
Mullen Receptive Language Scale
Mullen Receptive Language Scale SS
Communication and Symbolic Behavior Scale
CSBS Total Composite Score

Secondary Outcome Measures

Parent Child Interaction
NCAST Caregiver Total
Parent quality of life
Questionnaire on Resources and Stress Total Score

Full Information

First Posted
July 24, 2009
Last Updated
April 18, 2017
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
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1. Study Identification

Unique Protocol Identification Number
NCT00947700
Brief Title
Early Connections, Early Detection and Intervention in Infants at Risk for Autism
Official Title
UW ACE Project II, Early Detection and Intervention in Infants at Risk for Autism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Infants, Risk markers, ERP, Parent child interaction, Promoting First Relations, Social Communication

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Assessment & Monitoring
Arm Type
No Intervention
Arm Description
No Intervention. Parent-Child participants in assessment and monitoring visits but does not receive any study provided treatment.
Arm Title
Assessment, Monitoring + Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Assessment, Monitoring & Intervention
Other Intervention Name(s)
Promoting First Relationships
Intervention Description
Assessment and monitoring at 6, 12, 18 and 24 months; Parent delivered intervention provided between 6 and 12 months.
Primary Outcome Measure Information:
Title
Autism Symptoms
Description
AOSI
Time Frame
12 months
Title
Mullen Receptive Language Scale
Description
Mullen Receptive Language Scale SS
Time Frame
12 months
Title
Communication and Symbolic Behavior Scale
Description
CSBS Total Composite Score
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Parent Child Interaction
Description
NCAST Caregiver Total
Time Frame
12 months
Title
Parent quality of life
Description
Questionnaire on Resources and Stress Total Score
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan King, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sara J Webb, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Annette Estes, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center on Human Development and Disabilities, University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participant level data was submitted to NDAR.

Learn more about this trial

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

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