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

Autism Clinical Trial

Official title:

Early Identification and Service Linkage for Urban Children With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359084
• Other study ID #: H-33008
• Secondary ID: 1R01MH104355
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: August 25, 2021

Study information

• Verified date: December 2021
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: August 25, 2021
• Est. primary completion date: August 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Months to 27 Months

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autistic Disorder
• Developmental Delay Disorders
• Developmental Disabilities

Intervention

Behavioral:
• Family Navigation

• Conventional Care Management

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Boston University School of Public Health	Boston	Massachusetts
United States	Codman Square Health Center	Boston	Massachusetts
United States	Dorchester House Multi-Service Center	Boston	Massachusetts
United States	East Boston Neighborhood Health Center	Boston	Massachusetts
United States	South End Community Health Center	Boston	Massachusetts
United States	MGH Chelsea	Chelsea	Massachusetts
United States	Lowell Community Health Center	Lowell	Massachusetts
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Boston University	Children's Hospital of Philadelphia, Developmental Behavioral Pediatrics Research Network, National Institute of Mental Health (NIMH), Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceived Stress Scale - Self Report	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.	1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
Other	Parenting Stress Index - Short Form	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.	1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
Other	Brief COPE		1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
Other	Pearlin Mastery Scale	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.	1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
Other	VR12 Health Survey	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.	1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
Other	MOS-Social Support Survey	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.	1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
Other	Family Impact Questionnaire		1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
Other	Autism Parenting Stress Index (APSI)	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.	1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
Other	Adaptive Behavior Assessment System	Communication, Social, and Self-Direction subscales	1 year after failed confirmatory screen
Other	Brief Illness Perception Questionnaire		1 year after failed confirmatory screen
Other	Hospital Care Questionnaire		100 days after developmental assessment completion, 1 year after failed confirmatory screen
Other	Engagement in treatment	Number of hours of ASD/general developmental services	1 year
Other	Mullen Scales of Early Learning (MSEL)	Visual Reception, Fine Motor, Receptive Language, and Expressive Language scales	1 year after failed confirmatory screen
Other	Vineland Adaptive Behavior Scales-3	Parent/caregiver rating form; all domains except motor and maladaptive	1 year after failed confirmatory screen
Other	Autism Diagnostic Observation Schedule-2		at time of evaluation and 1 year after failed confirmatory screen
Primary	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
Primary	Time to receipt of ASD services/recommended services	Number of days from date of diagnosis to receipt of recommended services	1 year
Secondary	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.)	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.	1 year
Secondary	Satisfaction with Family Navigator (Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I))	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.	100 days after developmental assessment completion