Pediatric Early Autism Recognition System: PEARS

NCT05153551 | Completed

• 1 other identifier: HUM00203538
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Conditions

Autism Spectrum Disorder

Keywords

Early diagnosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

  Approximately day 35 (time 5)

Study Arms (1)

PEARS assessment

EXPERIMENTAL

Other: Play-based assessment (RITA-T)

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.

PEARS assessment

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• previous ASD diagnosis
• previous negative ASD evaluation
• known seizure disorder
• vision impairment
• hearing impairment
• \- Parent or legal guardian of the children
• \- Not a Parent or legal guardian of the child

Sponsors & Collaborators

• University of Michigan: lead
• Blue Cross Blue Shield of Michigan Foundation: collaborator

Study Sites (3)

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

Ann Arbor, Michigan, 48108, United States

Location

Michigan Medicine Brighton Health Center

Brighton, Michigan, 48116, United States

Location

Michigan Medicine Northville Health Center

Northville, Michigan, 48168, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Disease

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicole Hamp, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: House Officer, Developmental-Behavioral Pediatrics

Model Details: 30 families (30 children and 30 parents/legal guardians) to be enrolled

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: January 27, 2022
• Primary Completion: October 18, 2022
• Study Completion: October 18, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)