Autism Clinical Trial
Official title:
Early Identification and Service Linkage for Urban Children With Autism
Verified date | December 2021 |
Source | Boston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Boston University | Children's Hospital of Philadelphia, Developmental Behavioral Pediatrics Research Network, National Institute of Mental Health (NIMH), Yale University |
United States,
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 |
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