Pediatric Early Autism Recognition System: PEARS

University of Michigan

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Other: Play-based assessment (RITA-T)

Study type: Interventional

Funder types: Other

Identifiers

NCT05153551

HUM00203538

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

PEARS assessment

Experimental group

Treatment:

Other: Play-based assessment (RITA-T)