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

NCT ID: NCT01340092

Last Updated: 2016-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autistic Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Family Navigator

Family navigation

Group Type ACTIVE_COMPARATOR

Family Navigator

Intervention Type OTHER

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.

Standard Care

standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marilyn Augustyn

BMC Faculty

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marilyn Augustyn, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HRSA R40MC19928-01-00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

29964

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Trial of Autism Parent Navigator Program
NCT04744428 ACTIVE_NOT_RECRUITING NA
Cognitive Control and Metacognition Training
NCT06885684 NOT_YET_RECRUITING NA
Transitioning Together Boston
NCT05599711 ACTIVE_NOT_RECRUITING NA