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Pediatric Early Autism Recognition System: PEARS (PEARS)

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Play-based assessment (RITA-T)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Autism Spectrum Disorder focused on measuring Early diagnosis

Eligibility Criteria

18 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Michigan Medicine Briarwood Center for Women, Children, and Young Adults.
  • Michigan Medicine Brighton Health Center
  • Michigan Medicine Northville Health Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PEARS assessment

Arm Description

Outcomes

Primary Outcome Measures

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).
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).
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.
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.

Secondary Outcome Measures

The number of days between enrollment and completed RITA-T assessment
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.

Full Information

First Posted
November 29, 2021
Last Updated
October 18, 2022
Sponsor
University of Michigan
Collaborators
Blue Cross Blue Shield of Michigan Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05153551
Brief Title
Pediatric Early Autism Recognition System: PEARS
Acronym
PEARS
Official Title
Pediatric Early Autism Recognition System: PEARS
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 27, 2022 (Actual)
Primary Completion Date
October 18, 2022 (Actual)
Study Completion Date
October 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Blue Cross Blue Shield of Michigan Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Early diagnosis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
30 families (30 children and 30 parents/legal guardians) to be enrolled
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEARS assessment
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Play-based assessment (RITA-T)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of PEARS PCP visits in which PCPs report overall feasibility in regard to workflow, delivery, and administration of the RITA-T
Description
This is based on a 6 question feasibility survey (score of 24 or greater would be considered feasible).
Time Frame
Approximately day 7 (Time 3)
Title
Percentage of parents that felt that the RITA-T visit was comfortable and useful
Description
This is based on a 5 question feasibility survey (score of 20 or greater would be considered feasible).
Time Frame
Approximately day 35 (time 5)
Title
Change on the Parent Activation Measure for Children with Developmental Disabilities (PAM-DD)
Description
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.
Time Frame
Baseline(day 1), approximately day 35 (time 5)
Title
Qualitative data from parents semi-structured interviews
Description
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.
Time Frame
Approximately day 35 (time 5)
Secondary Outcome Measure Information:
Title
The number of days between enrollment and completed RITA-T assessment
Time Frame
Approximately 7-14 days
Title
The percentage of participants that experienced scheduling and/or transportation barriers
Description
This data will be collected by the research assistants or reported by parents during the follow-up semi-structured interview.
Time Frame
Approximately day 35 (time 5)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Hamp, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan Medicine Briarwood Center for Women, Children, and Young Adults.
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
Facility Name
Michigan Medicine Brighton Health Center
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48116
Country
United States
Facility Name
Michigan Medicine Northville Health Center
City
Northville
State/Province
Michigan
ZIP/Postal Code
48168
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pediatric Early Autism Recognition System: PEARS

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