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Project EARLY: Engagement, Assessment, Referral, & Linkage for Young Children

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ClinicalTrials.gov Identifier: NCT02359084
Recruitment Status : Recruiting
First Posted : February 9, 2015
Last Update Posted : June 23, 2017
Sponsor:
Collaborators:
Yale University
Children's Hospital of Philadelphia
National Institute of Mental Health (NIMH)
Developmental and Behavioral Pediatrics Research Network
Information provided by (Responsible Party):
Emily Feinberg, Boston University

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.


Condition or disease Intervention/treatment Phase
Autism Developmental Delay Disorders Behavioral: Family Navigation Behavioral: Conventional Care Management Not Applicable

Detailed Description:

We will conduct a randomized, comparative effectiveness trial to test a systemic, lay-delivered FN protocol against conventional care management services. The study will take place in three integrated primary care networks and their affiliated Developmental and Behavioral Pediatrics (DBP) clinics at Boston Medical Center, Children's Hospital of Philadelphia, and Yale University Medical School. We will enroll children with confirmed risk for ASD in the randomized trial and will employ 1:1 randomization by child. The FN protocol will include individualized navigation to support completion of the diagnostic evaluation, referral to appropriate services, and linkage to and engagement in services. We will determine FN's effect on identifying children at risk for ASD, timing of diagnosis, and receipt of evidence-based ASD services.

The study seeks to accomplish the following aims:

  1. Implement a decision rule for referral for formal ASD evaluation;
  2. Ensure timely diagnosis and deployment of services.

If successful, our study will provide real world primary care practices with a replicable model of care that increases early identification and access to timely diagnostic and early intervention services for a vulnerable population of urban families.

Children will be followed for 12 months. Data regarding screening outcomes, diagnosis and service utilization will be abstracted from children's medical records. Measures of parental stress, self-management skills, caregiver burden, and satisfaction with services will be administered over 4 collection time points, linked to key intervention outcomes. We will assess the superiority of FN as compared to CCM as a means to: implement a decision rule for referral to ASD evaluation; shorten the time to diagnosis among children suspected to have ASD; shorten the time to deployment of ASD services among those diagnosed; and improve engagement with ASD services.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Early Identification and Service Linkage for Urban Children With Autism
Actual Study Start Date : February 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: Family Navigation
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
Active Comparator: Conventional Care Management
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



Primary Outcome Measures :
  1. 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) [ Time Frame: On average 90 -120 days, specific date is linked to the completion of the developmental assessment ]
    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

  2. Time to receipt of ASD services/recommended services [ Time Frame: 1 year ]
    Number of days from date of diagnosis to receipt of recommended services


Secondary Outcome Measures :
  1. 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.) [ Time Frame: 1 year ]
    Determination of ASD diagnosis will be 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.

  2. Satisfaction with Family Navigator (Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I)) [ Time Frame: 100 days after developmental assessment completion ]
    Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I) is a newly validated 9 item scale to assess satisfaction with the interpersonal relationship with the navigator.


Other Outcome Measures:
  1. Perceived Stress Scale - Self Report [ Time Frame: 1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen ]
  2. Parenting Stress Index - Short Form [ Time Frame: 1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen ]
  3. Brief COPE [ Time Frame: 1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen ]
  4. Pearlin Mastery Scale [ Time Frame: 1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen ]
  5. VR12 Health Survey [ Time Frame: 1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen ]
  6. MOS-Social Support Survey [ Time Frame: 1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen ]
  7. Family Impact Questionnaire [ Time Frame: 1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen ]
  8. Autism Parenting Stress Index [ Time Frame: 1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen ]
  9. Adaptive Behavior Assessment System [ Time Frame: 1 year after failed confirmatory screen ]
    Communication, Social, and Self-Direction subscales

  10. Brief Illness Perception Questionnaire [ Time Frame: 1 year after failed confirmatory screen ]
  11. Hospital Care Questionnaire [ Time Frame: 100 days after developmental assessment completion, 1 year after failed confirmatory screen ]
  12. Engagement in treatment [ Time Frame: 1 year ]
    Number of hours of ASD/general developmental services



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Months to 27 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous diagnosis of Autism Spectrum Disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359084


Contacts
Contact: Emily Feinberg, ScD 617-414-1425 emfeinbe@bu.edu
Contact: Jenna Sandler, MPH 617-414-1386 jenmiche@bu.edu

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: Carol Weitzman, MD    203-785-7521    Carol.Weitzman@yale.edu   
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Boston University School of Public Health Recruiting
Boston, Massachusetts, United States, 02118
Contact: Emily Feinberg, ScD    617-414-1425    emfeinbe@bu.edu   
Contact: Jenna Sandler, MPH    617-414-1386    jenmiche@bu.edu   
South End Community Health Center Recruiting
Boston, Massachusetts, United States, 02118
Dorchester House Multi-Service Center Recruiting
Boston, Massachusetts, United States, 02122
Codman Square Health Center Recruiting
Boston, Massachusetts, United States, 02124
East Boston Neighborhood Health Center Recruiting
Boston, Massachusetts, United States, 02128
MGH Chelsea Recruiting
Chelsea, Massachusetts, United States, 02150
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Amanda Bennett Palladino, MD    267-426-5200    BennettAM@email.chop.edu   
Sponsors and Collaborators
Boston University
Yale University
Children's Hospital of Philadelphia
National Institute of Mental Health (NIMH)
Developmental and Behavioral Pediatrics Research Network
Investigators
Principal Investigator: Emily Feinberg, ScD Boston University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emily Feinberg, Associate Professor, Boston University
ClinicalTrials.gov Identifier: NCT02359084     History of Changes
Other Study ID Numbers: H-33008
1R01MH104355 ( U.S. NIH Grant/Contract )
First Posted: February 9, 2015    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with the National Database for Autism Research biannually.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Developmental Disabilities
Neurodevelopmental Disorders
Mental Disorders