Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT05153551
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2021-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pediatric Early Autism Recognition System: PEARS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '30 families (30 children and 30 parents/legal guardians) to be enrolled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2021-11-29', 'studyFirstSubmitQcDate': '2021-11-29', 'lastUpdatePostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of PEARS PCP visits in which PCPs report overall feasibility in regard to workflow, delivery, and administration of the RITA-T', 'timeFrame': 'Approximately day 7 (Time 3)', 'description': 'This is based on a 6 question feasibility survey (score of 24 or greater would be considered feasible).'}, {'measure': 'Percentage of parents that felt that the RITA-T visit was comfortable and useful', 'timeFrame': 'Approximately day 35 (time 5)', 'description': 'This is based on a 5 question feasibility survey (score of 20 or greater would be considered feasible).'}, {'measure': 'Change on the Parent Activation Measure for Children with Developmental Disabilities (PAM-DD)', 'timeFrame': 'Baseline(day 1), approximately day 35 (time 5)', '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.'}, {'measure': 'Qualitative data from parents semi-structured interviews', 'timeFrame': 'Approximately day 35 (time 5)', '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.'}], 'secondaryOutcomes': [{'measure': 'The number of days between enrollment and completed RITA-T assessment', 'timeFrame': 'Approximately 7-14 days'}, {'measure': 'The percentage of participants that experienced scheduling and/or transportation barriers', 'timeFrame': 'Approximately day 35 (time 5)', 'description': 'This data will be collected by the research assistants or reported by parents during the follow-up semi-structured interview.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early diagnosis'], 'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': "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.\n\nThe study hypotheses:\n\n1. The PEARS intervention will show high feasibility to primary care physicians (PCPs) and patient families.\n2. The PEARS intervention will lead to increased parent activation around autism diagnosis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria- Child:\n\n* Increased risk for Autism Spectrum Disorder (ASD) defined as:\n\n * positive Modified Checklist for Autism in Toddlers-Revised (MCHAT) (score greater than 3);\n * OR having a sibling or parent with ASD;\n * OR history of prematurity (gestational age less or equal 34 weeks);\n * OR other provider or parent concern for ASD.\n* Child age 18-36 months\n\nExclusion Criteria- Child:\n\n* previous ASD diagnosis\n* previous negative ASD evaluation\n* known seizure disorder\n* vision impairment\n* hearing impairment\n\nInclusion Criteria- Parent\n\n\\- Parent or legal guardian of the children\n\nExclusion Criteria- Parent\n\n\\- Not a Parent or legal guardian of the child'}, 'identificationModule': {'nctId': 'NCT05153551', 'acronym': 'PEARS', 'briefTitle': 'Pediatric Early Autism Recognition System: PEARS', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Pediatric Early Autism Recognition System: PEARS', 'orgStudyIdInfo': {'id': 'HUM00203538'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEARS assessment', 'interventionNames': ['Other: Play-based assessment (RITA-T)']}], 'interventions': [{'name': 'Play-based assessment (RITA-T)', 'type': 'OTHER', '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.\n\nIn addition, parents will complete certain assessments/surveys during the study to evaluate the program.', 'armGroupLabels': ['PEARS assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48108', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Medicine Briarwood Center for Women, Children, and Young Adults.', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48116', 'city': 'Brighton', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Medicine Brighton Health Center', 'geoPoint': {'lat': 42.52948, 'lon': -83.78022}}, {'zip': '48168', 'city': 'Northville', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Medicine Northville Health Center', 'geoPoint': {'lat': 42.43115, 'lon': -83.48327}}], 'overallOfficials': [{'name': 'Nicole Hamp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Blue Cross Blue Shield of Michigan Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'House Officer, Developmental-Behavioral Pediatrics', 'investigatorFullName': 'Nicole Hamp', 'investigatorAffiliation': 'University of Michigan'}}}}