Pediatric Early Autism Recognition System: PEARS

Autism Spectrum Disorder Clinical Trial

— PEARS  

Official title:

Pediatric Early Autism Recognition System: PEARS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05153551
• Other study ID #: HUM00203538
• Status: Completed
• Phase: N/A
• Start date: January 27, 2022
• Est. completion date: October 18, 2022

Study information

• Verified date: October 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 18, 2022
• Est. primary completion date: October 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Blue Cross Blue Shield of Michigan Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	The number of days between enrollment and completed RITA-T assessment		Approximately 7-14 days
Secondary	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)