Autism Spectrum Disorder
Conditions
Keywords
Early diagnosis
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.
Interventions
OTHERPlay-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.
Sponsors
Blue Cross Blue Shield of Michigan Foundation
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
30 families (30 children and 30 parents/legal guardians) to be enrolled
Eligibility
Sex/Gender
ALL
Age
18 Months to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed