Pediatric Early Autism Recognition System: PEARS

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Other: Play-based assessment (RITA-T)

• Registration Number: NCT05153551
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-11-29
• Study First Posted: 2021-12-10
• Study Start: 2022-01-27
• Status Verified: 2022-10
• Primary Completion: 2022-10-18
• Study Completion: 2022-10-18
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEARS assessment	Play-based assessment (RITA-T)	-

Primary Outcome Measures

Name	Time	Method
Proportion of PEARS PCP visits in which PCPs report overall feasibility in regard to workflow, delivery, and administration of the RITA-T	Approximately day 7 (Time 3)	This is based on a 6 question feasibility survey (score of 24 or greater would be considered feasible).
Percentage of parents that felt that the RITA-T visit was comfortable and useful	Approximately day 35 (time 5)	This is based on a 5 question feasibility survey (score of 20 or greater would be considered feasible).
Change on the Parent Activation Measure for Children with Developmental Disabilities (PAM-DD)	Baseline(day 1), approximately day 35 (time 5)	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.
Qualitative data from parents semi-structured interviews	Approximately day 35 (time 5)	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.

Secondary Outcome Measures

Name	Time	Method
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)	This data will be collected by the research assistants or reported by parents during the follow-up semi-structured interview.

Trial Locations

Locations (3)

Michigan Medicine Brighton Health Center; 🇺🇸 Brighton, Michigan, United States

Michigan Medicine Briarwood Center for Women, Children, and Young Adults.; 🇺🇸 Ann Arbor, Michigan, United States

Michigan Medicine Northville Health Center; 🇺🇸 Northville, Michigan, United States