NCT02359084

Brief Summary

Emerging evidence demonstrates that Autism Spectrum Disorder (ASD) can be reliably diagnosed by age two, and that early identification and intervention can improve outcomes. Low-income and minority children with ASD, however, are diagnosed later and experience greater delays in service provision than their white and more financially advantaged peers. Feasible, culturally appropriate interventions with broad scale-up potential are necessary to reduce this disparity. This project builds upon pilot studies of an adapted version of Patient Navigation, as means to reduce disparities in ASD diagnosis and service provision. Patient Navigation is a lay-delivered case management approach that focuses on overcoming logistical hurdles to care during a defined episode. This project has 2 components, both of which take place in urban, integrated care networks that provide healthcare to low-income children. This registration is for the clinical trial component of the study. The project is a multisite, randomized comparative effectiveness trial of a systemic, lay-delivered adaptation of Patient Navigation, referred to as Family Navigation (FN), which begins with a failed autism screen and ends 100 days after an ASD diagnosis is made. The basic structure of both intervention arms is a collaborative care system. The conventional care management arm (CCM) is consistent with the type of care provided within a traditional - but high quality - medical home. The FN arm provides more intensive, individually tailored, care coordination and theory-based family support.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2021

Completed
Last Updated

January 3, 2022

Status Verified

December 1, 2021

Enrollment Period

6.6 years

First QC Date

February 1, 2015

Last Update Submit

December 30, 2021

Conditions

AutismDevelopmental Delay Disorders

Keywords

Autism Spectrum Disorder (ASD)Family navigation

Outcome Measures

Primary Outcomes (2)

  • Diagnostic interval (Number of days defined as beginning the day of the positive confirmatory screen and ending the day when the family receives a determination (yes/no) of ASD diagnosis)

    Number of days defined as beginning the day of the positive confirmatory screen and ending the day when the family receives a determination (yes/no) of ASD diagnosis

    On average 90 -120 days, specific date is linked to the completion of the developmental assessment

  • Time to receipt of ASD services/recommended services

    Number of days from date of diagnosis to receipt of recommended services

    1 year

Secondary Outcomes (2)

  • Determination of ASD diagnosis (based on DSM V criteria made by a Board Certified DBP Pediatrician. Assessments are based on site protocols; all use standardized, validated measures appropriate for very young children.)

    1 year

  • Satisfaction with Family Navigator (Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I))

    100 days after developmental assessment completion

Other Outcomes (15)

  • Perceived Stress Scale - Self Report

    1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen

  • Parenting Stress Index - Short Form

    1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen

  • Brief COPE

    1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen

  • +12 more other outcomes

Study Arms (2)

Family Navigation

EXPERIMENTAL

Families will work one-on-one with the navigator who provides off-site support - e.g. home visits or accompanying families to appointments. The goal of FN during the diagnostic evaluation period is to ensure timely completion of the evaluation. The focus of these interactions is to understand the structure and purpose of the evaluation, gather and complete required materials, and address logistic barriers related to the diagnostic visit. The navigator will continue to work with the family after the diagnostic evaluation to access recommended services and support the family's engagement in treatment.

Behavioral: Family Navigation

Conventional Care Management

ACTIVE COMPARATOR

Families will be assigned to a care manager for the diagnostic evaluation and for 100 days thereafter. Consistent with a high quality medical home, the care manager will be responsible to ensure that the referral for the diagnostic evaluation has been made. She is also available for family-initiated support. The care manager will be responsible for ensuring that referrals are made and continue to provide family-initiated, clinic-based support to families for up to 100 days after the completion of diagnostic evaluation.

Behavioral: Conventional Care Management

Interventions

Family NavigationBEHAVIORAL
Family Navigation
Conventional Care ManagementBEHAVIORAL
Conventional Care Management

Eligibility Criteria

Age15 Months - 27 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children ages 15 - 27 months at a participating clinic who fail the M-CHAT screen and/or primary care provider has concerns about autism

You may not qualify if:

  • Previous diagnosis of Autism Spectrum Disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Boston University School of Public Health

Boston, Massachusetts, 02118, United States

Location

South End Community Health Center

Boston, Massachusetts, 02118, United States

Location

Dorchester House Multi-Service Center

Boston, Massachusetts, 02122, United States

Location

Codman Square Health Center

Boston, Massachusetts, 02124, United States

Location

East Boston Neighborhood Health Center

Boston, Massachusetts, 02128, United States

Location

MGH Chelsea

Chelsea, Massachusetts, 02150, United States

Location

Lowell Community Health Center

Lowell, Massachusetts, 01854, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

  • Levinson J, Hickey E, Fuchu P, Chu A, Barnett M, Stadnick NA, Feinberg E, Broder-Fingert S. Recommendations for post-implementation adaptations to optimize family navigation in pediatric primary care: a qualitative study with parents and navigators. BMC Prim Care. 2023 Jun 16;24(1):123. doi: 10.1186/s12875-023-02072-y.

    PMID: 37328810DERIVED

  • Eilenberg JS, Kizildag D, Blakey AO, Cardona ND, Oberoi A, Broder-Fingert S, Feinberg E, Long KA. Implications of Universal Autism Screening: Perspectives From Culturally Diverse Families With False-Positive Screens. Acad Pediatr. 2022 Mar;22(2):279-288. doi: 10.1016/j.acap.2021.12.025. Epub 2021 Dec 25.

    PMID: 34963655DERIVED

  • Feinberg E, Augustyn M, Broder-Fingert S, Bennett A, Weitzman C, Kuhn J, Hickey E, Chu A, Levinson J, Sandler Eilenberg J, Silverstein M, Cabral HJ, Patts G, Diaz-Linhart Y, Fernandez-Pastrana I, Rosenberg J, Miller JS, Guevara JP, Fenick AM, Blum NJ. Effect of Family Navigation on Diagnostic Ascertainment Among Children at Risk for Autism: A Randomized Clinical Trial From DBPNet. JAMA Pediatr. 2021 Mar 1;175(3):243-250. doi: 10.1001/jamapediatrics.2020.5218.

    PMID: 33427861DERIVED

  • Broder-Fingert S, Walls M, Augustyn M, Beidas R, Mandell D, Wiltsey-Stirman S, Silverstein M, Feinberg E. A hybrid type I randomized effectiveness-implementation trial of patient navigation to improve access to services for children with autism spectrum disorder. BMC Psychiatry. 2018 Mar 27;18(1):79. doi: 10.1186/s12888-018-1661-7.

    PMID: 29587698DERIVED

MeSH Terms

Conditions

Autistic DisorderDevelopmental DisabilitiesAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Emily Feinberg, ScD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2015

First Posted

February 9, 2015

Study Start

February 1, 2015

Primary Completion

August 25, 2021

Study Completion

August 25, 2021

Last Updated

January 3, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share

Data will be shared with the National Database for Autism Research biannually.

Locations

US(10)