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

Autistic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340092
• Other study ID #: 29964
• Secondary ID: HRSA R40MC19928-
• Status: Completed
• Phase: N/A
• First received: April 20, 2011
• Last updated: April 22, 2016
• Start date: April 2011
• Est. completion date: May 2014

Study information

• Verified date: April 2016
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

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

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hours of Services	Mean number of autism-specific service hours received per week	6 months after enrollment	No
Primary	Receipt of adequate services	As defined by 25 hours/week	6 months after enrollment	No
Primary	Time to Receipt of Services	Difference between the date of the IEP/IFPS and date the child first received services	6 months after enrollment	No
Secondary	Family Psychological Functioning	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	No
Secondary	Family Psychological Functioning	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	No