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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01340092
First Posted: April 22, 2011
Last Update Posted: April 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marilyn Augustyn, Boston Medical Center
  Purpose
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.

Condition Intervention
Autistic Disorder Other: Family Navigator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Use of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder

Resource links provided by NLM:


Further study details as provided by Marilyn Augustyn, Boston Medical Center:

Primary Outcome Measures:
  • Hours of Services [ Time Frame: 6 months after enrollment ]
    Mean number of autism-specific service hours received per week

  • Receipt of adequate services [ Time Frame: 6 months after enrollment ]
    As defined by 25 hours/week

  • 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


Secondary Outcome Measures:
  • 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)

  • 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)


Enrollment: 192
Study Start Date: April 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: Standard Care
standard care

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340092


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Marilyn Augustyn, MD Boston Medical Center
  More Information

Responsible Party: Marilyn Augustyn, BMC Faculty, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01340092     History of Changes
Other Study ID Numbers: 29964
HRSA R40MC19928-01-00 ( Other Grant/Funding Number: HRSA )
First Submitted: April 20, 2011
First Posted: April 22, 2011
Last Update Posted: April 25, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marilyn Augustyn, Boston Medical Center:
Family Navigator
Autistic Disorder
Early Intervention
Developmental Disabilities
Child Development Disorders

Additional relevant MeSH terms:
Disease
Autism Spectrum Disorder
Autistic Disorder
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders


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