Pediatric Early Autism Recognition System: PEARS

Study Overview
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Brief Summary
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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.

Official Title
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Pediatric Early Autism Recognition System: PEARS

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Other: Play-based assessment (RITA-T)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: 30 families (30 children and 30 parents/legal guardians) to be enrolled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEARS assessment<br> | Other: Play-based assessment (RITA-T)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early diagnosis