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Completed

NCT Number: NCT02359084

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

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Developmental Delay Disorders Developmental Disabilities Mental Disorders Neurodevelopmental Disorders

Age range

15 month–27 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine, New Haven, Connecticut, United States

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About this study

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:

  • Implement a decision rule for referral for formal ASD evaluation;
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family Navigation

Behavioral

Conventional Care Management

Behavioral

Primary outcomes

  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 outcomes

  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 outcomes

  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

    The Perceived STress Scale is a measure of the degree to which situations in one's life are appraised as stressful. The questions in the PSS ask about feelings and thoughts during the last month. In each case, respondents are asked how often they felt a certain way.; lower scores are more favorable.

  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

    This measure is a brief version of the Parenting Stress Index, a widely used and well-researched measure of parenting stress. The PSI-SF has 36 items from the original 120-item PSI. Items are identical to those in the original version. It was developed in response to clinicians' and researchers' need for a shorter measure of parenting stress and was based on Castaldi's factor analysis of the original PSI, which suggested the presence of three factors. It yields scores on the following subscales: 1) Parental Distress, 2) Parent-Child Dysfunctional Interaction, and 3) Difficult Child. Similar to the full PSI, it also has a validity scale.

  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

    The Pearlin Mastery Scale is designed to measure self-concept and references the extent to which individuals perceive themselves in control of forces that significantly impact their lives. Total score can range from 7 to 28 points; higher scores are more favorable.

  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

    VR-12 includes 12 original question items from the VR-36. The questions in this survey correspond to seven different health domains: general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health.

  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

    This is a brief, multidimensional, self-administered, social support survey that was developed for patients in the Medical Outcomes Study (MOS), a two-year study of patients with chronic conditions. This survey was designed to be comprehensive in terms of recent thinking about the various dimensions of social support.

  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 (APSI)

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

    Screening and triage measure for evaluating the parenting system and identifying issues that may lead to problems in the child's or parent's behavior. Focuses on three major domains of stress: child characteristics, parent characteristics and situational/demographic life stress.

  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

  13. Mullen Scales of Early Learning (MSEL)

    Time frame: 1 year after failed confirmatory screen

    Visual Reception, Fine Motor, Receptive Language, and Expressive Language scales

  14. Vineland Adaptive Behavior Scales-3

    Time frame: 1 year after failed confirmatory screen

    Parent/caregiver rating form; all domains except motor and maladaptive

  15. Autism Diagnostic Observation Schedule-2

    Time frame: at time of evaluation and 1 year after failed confirmatory screen

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Children's Hospital of Philadelphia
  • Developmental Behavioral Pediatrics Research Network
  • National Institute of Mental Health (NIMH)
  • Yale University

Registry information

Official study title

Early Identification and Service Linkage for Urban Children With Autism

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2015
Registry last updated
Jan 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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