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Clinical Trials/NCT05153551
NCT05153551
Completed
N/A

Pediatric Early Autism Recognition System: PEARS

University of Michigan3 sites in 1 country60 target enrollmentJanuary 27, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
University of Michigan
Enrollment
60
Locations
3
Primary Endpoint
Proportion of PEARS PCP visits in which PCPs report overall feasibility in regard to workflow, delivery, and administration of the RITA-T
Status
Completed
Last Updated
3 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
January 27, 2022
End Date
October 18, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nicole Hamp

House Officer, Developmental-Behavioral Pediatrics

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

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

Time Frame: 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

Time Frame: 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)

Time Frame: 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

Time Frame: 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 Outcomes

  • 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 Sites (3)

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