Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
Study NCT ID:
NCT04744428
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-07
First Post:
2020-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial of Autism Parent Navigator Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2020-04-09', 'studyFirstSubmitQcDate': '2021-02-03', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weekly Count of Service Navigation Behaviors', 'timeFrame': '12 month', 'description': 'Engagement with ASD-related Services'}, {'measure': 'Parenting Scale (Arnold)', 'timeFrame': '12 month', 'description': 'Parenting consistency, warmth'}, {'measure': 'CES-Depression', 'timeFrame': '12 month', 'description': 'Parent depression'}], 'secondaryOutcomes': [{'measure': 'Coparenting Relationship Scale (Feinberg, Brown, & Kan, 2012)', 'timeFrame': '12 month', 'description': 'Coparenting Support'}, {'measure': 'Family Empowerment Scale - FES', 'timeFrame': '12 month', 'description': 'Parent Efficacy regarding Service Access'}, {'measure': 'PDD-BI', 'timeFrame': '12 month', 'description': 'Challenging Child Behaviors: Aggression, Non-compliance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'To address the dual needs of parents for support in navigating Autistic Spectrum Disorder (ASD) services and maintaining positive family functioning, the investigators propose to test Autism Parent Navigators (APN), an innovative in-home, peer support model for parents with a young child recently diagnosed with ASD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents of children who have been newly diagnosed with Autism Spectrum Disorder (ASD).\n* The child will be age 2-6 years and been diagnosed with ASD in the past four months.\n* The child is the first child in the family to be diagnosed with ASD.\n* Parents are not already involved in a parent mentoring relationship.\n* Parents are currently involved in a couple relationship, including same-sex partners, dating couples, adoptive parents and step-parent families.\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT04744428', 'acronym': 'APN', 'briefTitle': 'Trial of Autism Parent Navigator Program', 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': 'Test of an Innovative, Scalable Support Program for Parents With a Young Child Recently Diagnosed With Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': 'APN-RT01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autism Parent Navigators Intervention', 'description': 'Autism Parent Navigators Intervention is a manualized, in-home, peer support model for parents with a young child recently diagnosed with ASD.', 'interventionNames': ['Behavioral: Autism Parent Navigators']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Peer mentoring', 'description': 'Peer mentors will offer an equivalent number of in-home or telephone visits for families, providing non-manualized peer support.', 'interventionNames': ['Behavioral: Peer mentoring']}], 'interventions': [{'name': 'Autism Parent Navigators', 'type': 'BEHAVIORAL', 'description': 'The Autism Parent Navigator program consists of six sessions delivered to parents in the home, supporting adjustment to ASD, accessing services, and coparenting support.', 'armGroupLabels': ['Autism Parent Navigators Intervention']}, {'name': 'Peer mentoring', 'type': 'BEHAVIORAL', 'description': 'Six in-home or telephone sessions, depending on family uptake, providing non-manualized general support as usual from parent peer mentors regarding adjustment to ASD.', 'armGroupLabels': ['Peer mentoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29204', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'USC', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'overallOfficials': [{'name': 'Mark Feinberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penn State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of South Carolina', 'class': 'OTHER'}, {'name': 'Family Connections', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Professor', 'investigatorFullName': 'Mark Feinberg', 'investigatorAffiliation': 'Feinberg, Mark, Ph.D.'}}}}