Back to resultsUse of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder
Primary Purpose
Autistic Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Navigator
Sponsored by
About this trial
This is an interventional supportive care trial for Autistic Disorder focused on measuring Family Navigator, Autistic Disorder, Early Intervention, Developmental Disabilities, Child Development Disorders
Eligibility 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
Sites / Locations
- Boston Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Family Navigator
Standard Care
Arm Description
Family navigation
standard care
Outcomes
Primary Outcome Measures
Hours of Services
Mean number of autism-specific service hours received per week
Receipt of adequate services
As defined by 25 hours/week
Time to Receipt of Services
Difference between the date of the IEP/IFPS and date the child first received services
Secondary Outcome Measures
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01340092
Brief Title
Use of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder
Official Title
Use of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
Keywords
Family Navigator, Autistic Disorder, Early Intervention, Developmental Disabilities, Child Development Disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Family Navigator
Arm Type
Active Comparator
Arm Description
Family navigation
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
standard care
Intervention Type
Other
Intervention Name(s)
Family Navigator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hours of Services
Description
Mean number of autism-specific service hours received per week
Time Frame
6 months after enrollment
Title
Receipt of adequate services
Description
As defined by 25 hours/week
Time Frame
6 months after enrollment
Title
Time to Receipt of Services
Description
Difference between the date of the IEP/IFPS and date the child first received services
Time Frame
6 months after enrollment
Secondary Outcome Measure Information:
Title
Family Psychological Functioning
Description
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)
Time Frame
6 months after enrollment
Title
Family Psychological Functioning
Description
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)
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilyn Augustyn, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder
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