NCT00947700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

5.4 years

First QC Date

July 24, 2009

Last Update Submit

April 18, 2017

Conditions

Autism Spectrum Disorder

Keywords

InfantsRisk markersERPParent child interactionPromoting First RelationsSocial Communication

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Parent Child Interaction

    12 months

  • Parent quality of life

    12 months

Study Arms (2)

Assessment & Monitoring

NO INTERVENTION

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

Assessment, Monitoring + Intervention

EXPERIMENTAL

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

Interventions

Assessment, Monitoring & InterventionBEHAVIORAL

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

Also known as: Promoting First Relationships
Assessment, Monitoring + Intervention

Eligibility Criteria

Age5 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center on Human Development and Disabilities, University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderCommunication

Interventions

Restraint, PhysicalMethods

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Bryan King, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Sara J Webb, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Annette Estes, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 28, 2009

Study Start

January 1, 2008

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

April 20, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Participant level data was submitted to NDAR.

Locations

US(1)