Pediatric Early Autism Recognition System: PEARS

University of Michigan60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Autism Spectrum Disorder

Interventions

Play-based assessment (RITA-T)OTHER

The RITA-T is a play-based assessment that involves nine different activities that can be done safely with a child seated in the exam room. After scoring the RITA-T, the PEARS PCP will immediately provide feedback to the parent regarding results and next steps. In addition, parents will complete certain assessments/surveys during the study to evaluate the program.

Eligibility

Sex: ALLMin age: 18 Months

Medical Language ↔ Plain English

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

Locations (3)

Michigan Medicine Briarwood Center for Women, Children, and Young Adults.

Ann Arbor, Michigan, United States

Michigan Medicine Brighton Health Center

Brighton, Michigan, United States

Michigan Medicine Northville Health Center

Northville, Michigan, United States

Outcomes

Primary Outcomes

Proportion of PEARS PCP visits in which PCPs report overall feasibility in regard to workflow, delivery, and administration of the RITA-T

This is based on a 6 question feasibility survey (score of 24 or greater would be considered feasible).

Time frame: Approximately day 7 (Time 3)

Percentage of parents that felt that the RITA-T visit was comfortable and useful

This is based on a 5 question feasibility survey (score of 20 or greater would be considered feasible).

Time frame: Approximately day 35 (time 5)

Change on the Parent Activation Measure for Children with Developmental Disabilities (PAM-DD)

Items are scored using a 4-point a Likert-type scale (1 = disagree strongly to 4 = agree strongly). Raw scores are summed and scaled from 0 to 100 using weighted scores based on Guttman scaling. Higher scores correspond to higher activation. This 13-item measure will be administered verbally to parents at baseline and 3-4 weeks post-RITA-T assessment. Changes from baseline to follow-up will be calculated for each participant.

Time frame: Baseline(day 1), approximately day 35 (time 5)

Qualitative data from parents semi-structured interviews

The study team will analyze transcripts of parent semi-structured interviews to assess general sense of empowerment and motivation, with a focus on novel insights into the experience of parents of children undergoing a Level-2 screening instrument within the medical home.

Time frame: Approximately day 35 (time 5)

Secondary Outcomes

The number of days between enrollment and completed RITA-T assessment

Time frame: Approximately 7-14 days

The percentage of participants that experienced scheduling and/or transportation barriers

Data from ClinicalTrials.gov

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