Clinical trial NCT02359084: Project EARLY: Engagement, Assessment, Referral, & Linkage for Young Children
Official title: Early Identification and Service Linkage for Urban Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Developmental Delay Disorders
Keywords: Autism Spectrum Disorder (ASD)
Family navigation
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Yale University
name: Children's Hospital of Philadelphia
name: National Institute of Mental Health (NIMH)
name: Developmental Behavioral Pediatrics Research Network
First posted: 2015-02-09
Enrollment: 340
Sex: ALL
Minimum age (years): 15
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: On average 90 -120 days, specific date is linked to the completion of the developmental assessment
measure: Time to receipt of ASD services/recommended services
timeFrame: 1 year
Secondary outcomes:
measure: 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.)
timeFrame: 1 year
measure: Satisfaction with Family Navigator (Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I))
timeFrame: 100 days after developmental assessment completion
Other outcomes:
measure: Perceived Stress Scale - Self Report
timeFrame: 1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
measure: Parenting Stress Index - Short Form
timeFrame: 1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
measure: Brief COPE
timeFrame: 1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
measure: Pearlin Mastery Scale
timeFrame: 1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
measure: VR12 Health Survey
timeFrame: 1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
measure: MOS-Social Support Survey
timeFrame: 1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
measure: Family Impact Questionnaire
timeFrame: 1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
measure: Autism Parenting Stress Index (APSI)
timeFrame: 1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
measure: Adaptive Behavior Assessment System
timeFrame: 1 year after failed confirmatory screen
measure: Brief Illness Perception Questionnaire
timeFrame: 1 year after failed confirmatory screen
measure: Hospital Care Questionnaire
timeFrame: 100 days after developmental assessment completion, 1 year after failed confirmatory screen
measure: Engagement in treatment
timeFrame: 1 year
measure: Mullen Scales of Early Learning (MSEL)
timeFrame: 1 year after failed confirmatory screen
measure: Vineland Adaptive Behavior Scales-3
timeFrame: 1 year after failed confirmatory screen
measure: Autism Diagnostic Observation Schedule-2
timeFrame: at time of evaluation and 1 year after failed confirmatory screen
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston University School of Public Health
state: Massachusetts
city: Boston
country: United States
facility: South End Community Health Center
state: Massachusetts
city: Boston
country: United States
facility: Dorchester House Multi-Service Center
state: Massachusetts
city: Boston
country: United States
facility: Codman Square Health Center
state: Massachusetts
city: Boston
country: United States
facility: East Boston Neighborhood Health Center
state: Massachusetts
city: Chelsea
country: United States
facility: MGH Chelsea
state: Massachusetts
city: Lowell
country: United States
facility: Lowell Community Health Center
state: Massachusetts
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Boston University
name: Emily Feinberg, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.