Pediatric Early Autism Recognition System: PEARS (PEARS)

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 Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: Play-based assessment (RITA-T)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • Michigan Medicine Briarwood Center for Women, Children, and Young Adults.
    • Brighton, Michigan, United States, 48116
      • Michigan Medicine Brighton Health Center
    • Northville, Michigan, United States, 48168
      • Michigan Medicine Northville Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PEARS assessment

Other: Play-based assessment (RITA-T); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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.	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.	Approximately day 35 (time 5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of days between enrollment and completed RITA-T assessment		Approximately 7-14 days
The percentage of participants that experienced scheduling and/or transportation barriers	This data will be collected by the research assistants or reported by parents during the follow-up semi-structured interview.	Approximately day 35 (time 5)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Blue Cross Blue Shield of Michigan Foundation
• Investigators: Principal Investigator: Nicole Hamp, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2022
• Primary Completion (Actual): October 18, 2022
• Study Completion (Actual): October 18, 2022

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Early diagnosis
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: HUM00203538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No