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| Name | Class |
|---|---|
| Blue Cross Blue Shield of Michigan Foundation | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEARS assessment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Play-based assessment (RITA-T) | Other | 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. |
| 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) |
| 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. |
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Inclusion Criteria- Child:
Increased risk for Autism Spectrum Disorder (ASD) defined as:
Child age 18-36 months
Exclusion Criteria- Child:
Inclusion Criteria- Parent
- Parent or legal guardian of the children
Exclusion Criteria- Parent
- Not a Parent or legal guardian of the child
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Hamp, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Medicine Briarwood Center for Women, Children, and Young Adults. | Ann Arbor | Michigan | 48108 | United States | ||
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D004194 | Disease |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
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30 families (30 children and 30 parents/legal guardians) to be enrolled
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| Approximately day 35 (time 5) |
| Michigan Medicine Brighton Health Center |
| Brighton |
| Michigan |
| 48116 |
| United States |
| Michigan Medicine Northville Health Center | Northville | Michigan | 48168 | United States |
| D013568 | Pathological Conditions, Signs and Symptoms |