NCT01340092

Brief Summary

The purpose of this study is to see whether or not Family Navigators, who 1 ) help families after their child is diagnosed with autism and help them get autism specific services for their child 2) help families identify barriers to obtaining these services and 3) help families problem solve to overcome these barrier, are helpful to parents of a child newly diagnosed with an Autism Spectrum Disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration 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

April 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

3.1 years

First QC Date

April 20, 2011

Last Update Submit

April 22, 2016

Conditions

Keywords

Family NavigatorAutistic DisorderEarly InterventionDevelopmental DisabilitiesChild Development Disorders

Outcome Measures

Primary Outcomes (3)

  • Hours of Services

    Mean number of autism-specific service hours received per week

    6 months after enrollment

  • Receipt of adequate services

    As defined by 25 hours/week

    6 months after enrollment

  • Time to Receipt of Services

    Difference between the date of the IEP/IFPS and date the child first received services

    6 months after enrollment

Secondary Outcomes (2)

  • Family Psychological Functioning

    6 months after enrollment

  • Family Psychological Functioning

    Baseline

Study Arms (2)

Family Navigator

ACTIVE COMPARATOR

Family navigation

Other: Family Navigator

Standard Care

NO INTERVENTION

standard care

Interventions

Families in the intervention group will receive approximately six sessions with a Family Navigator. The Family Navigator will: 1. Help family identify key issues they need to address to get their child autism-specific services 2. Help family address barriers to obtaining these services and strategize approaches to overcome them.

Family Navigator

Eligibility Criteria

Age15 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Child with a new confirmed diagnosis of Autism Spectrum Disorder
  • Child is under 8 years of age
  • Parent is the mother, father and/or legal guardian of the child and identifies themselves as the primary caregiver
  • Primary caregiver speaks English, Spanish, Haitian Creole, Somali, Vietnamese, Portuguese or Chinese

You may not qualify if:

  • Parent or legal guardian has psychosis
  • Parent or legal guardian endorses suicidal ideation
  • Parent or legal guardian actively using illicit drugs
  • Parent or legal guardian expected to leave area within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Autistic DisorderDevelopmental Disabilities

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Marilyn Augustyn, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BMC Faculty

Study Record Dates

First Submitted

April 20, 2011

First Posted

April 22, 2011

Study Start

April 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

April 25, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations