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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01340092
First received: April 20, 2011
Last updated: March 19, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Boston Medical Center:

Primary Outcome Measures:
  • Hours of Services [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
    Mean number of autism-specific service hours received per week

  • Receipt of adequate services [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
    As defined by 25 hours/week

  • Time to Receipt of Services [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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)


Estimated Enrollment: 192
Study Start Date: April 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Family Navigator 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

  Eligibility

Ages Eligible for Study:   15 Years to 64 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT01340092     History of Changes
Other Study ID Numbers: 29964, HRSA R40MC19928-01-00
Study First Received: April 20, 2011
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes

ClinicalTrials.gov processed this record on October 30, 2014