Clinical trial NCT05153551: Pediatric Early Autism Recognition System: PEARS
Official title: Pediatric Early Autism Recognition System: PEARS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Early diagnosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield of Michigan Foundation
First posted: 2021-12-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 30 families (30 children and 30 parents/legal guardians) to be enrolled
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of the study is to assess a new autism evaluation model that would include the addition of a Level-2 autism screener, the Rapid Interactive Screening Test for Autism in Toddlers (RITA-T), to the developmental screening already done by the child's pediatrician.

The study hypotheses:

1. The PEARS intervention will show high feasibility to primary care physicians (PCPs) and patient families.
2. The PEARS intervention will lead to increased parent activation around autism diagnosis.


Eligibility criteria: Inclusion Criteria- Child:

* Increased risk for Autism Spectrum Disorder (ASD) defined as:

  * positive Modified Checklist for Autism in Toddlers-Revised (MCHAT) (score greater than 3);
  * OR having a sibling or parent with ASD;
  * OR history of prematurity (gestational age less or equal 34 weeks);
  * OR other provider or parent concern for ASD.
* Child age 18-36 months

Exclusion Criteria- Child:

* previous ASD diagnosis
* previous negative ASD evaluation
* known seizure disorder
* vision impairment
* hearing impairment

Inclusion Criteria- Parent

- Parent or legal guardian of the children

Exclusion Criteria- Parent

- Not a Parent or legal guardian of the child

Primary outcomes:
measure: Proportion of PEARS PCP visits in which PCPs report overall feasibility in regard to workflow, delivery, and administration of the RITA-T
timeFrame: Approximately day 7 (Time 3)
measure: Percentage of parents that felt that the RITA-T visit was comfortable and useful
timeFrame: Approximately day 35 (time 5)
measure: Change on the Parent Activation Measure for Children with Developmental Disabilities (PAM-DD)
timeFrame: Baseline(day 1), approximately day 35 (time 5)
measure: Qualitative data from parents semi-structured interviews
timeFrame: Approximately day 35 (time 5)
Secondary outcomes:
measure: The number of days between enrollment and completed RITA-T assessment
timeFrame: Approximately 7-14 days
measure: The percentage of participants that experienced scheduling and/or transportation barriers
timeFrame: Approximately day 35 (time 5)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine Briarwood Center for Women, Children, and Young Adults.
state: Michigan
city: Brighton
country: United States
facility: Michigan Medicine Brighton Health Center
state: Michigan
city: Northville
country: United States
facility: Michigan Medicine Northville Health Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Nicole Hamp, MD
role: PRINCIPAL_INVESTIGATOR
References: