Use of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder

April 22, 2016 updated by: Marilyn Augustyn, Boston Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 64 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care
standard care
Active Comparator: Family Navigator
Family navigation
Other: Family Navigator

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hours of Services
Time Frame: 6 months after enrollment
Mean number of autism-specific service hours received per week
6 months after enrollment
Receipt of adequate services
Time Frame: 6 months after enrollment
As defined by 25 hours/week
6 months after enrollment
Time to Receipt of Services
Time Frame: 6 months after enrollment
Difference between the date of the IEP/IFPS and date the child first received services
6 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family Psychological Functioning
Time Frame: 6 months after enrollment
  • Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR).
  • Parenting Stress - Short Form (PSI)
  • Perceived Stress Scale- Self-Report (PSS)
  • Medical Outcomes Study Social Support (MOS-SS)
6 months after enrollment
Family Psychological Functioning
Time Frame: Baseline
  • Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR).
  • Parenting Stress - Short Form (PSI)
  • Perceived Stress Scale- Self-Report (PSS)
  • Medical Outcomes Study Social Support (MOS-SS)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Investigators

  • Principal Investigator: Marilyn Augustyn, MD, Boston Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

April 20, 2011

First Submitted That Met QC Criteria

April 20, 2011

First Posted (Estimate)

April 22, 2011

Study Record Updates

Last Update Posted (Estimate)

April 25, 2016

Last Update Submitted That Met QC Criteria

April 22, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29964
  • HRSA R40MC19928-01-00 (Other Grant/Funding Number: HRSA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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