Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-01-21 @ 10:20 PM
Study NCT ID:
NCT05214118
Status:
COMPLETED
Last Update Posted:
2025-07-18
First Post:
2022-01-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bringing Education Through Technology, Empathic Listening, and Research
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'caitlin.martin@vcuhealth.org', 'phone': '(804) 628-7023', 'title': 'Dr. Caitlin E. Martin', 'organization': 'Virginia Commonwealth University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'February 2022-October 2023 overall for the study. During the duration of study involvement individually for each subject which is Baseline to within 2 weeks of completing the intervention, up to 5 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Brochure', 'description': 'No intervention, brochure', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Technology-based Program', 'description': 'technology-based program: Participants will be asked to complete three 25-minute modules covering the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Cardiac disorders', 'notes': 'Participant was placed on extracorporeal membrane oxygenation and had to be ventilated, participants fetus did not survive.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brochure', 'description': 'No intervention, brochure'}, {'id': 'OG001', 'title': 'Technology-based Program', 'description': 'technology-based program: Participants will be asked to complete three 25-minute modules covering the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.5', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '21.2', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 2 weeks of completing the intervention', 'description': 'Participants will complete a survey about the feasibility of the intervention consisting of 4 items rated on a 0 to 6 scale. Scores will be summed to yield a final feasibility score ranging from 0 to 24. Higher scores indicate higher feasibility.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants will complete a survey about the feasibility of the intervention consisting of 4 items rated on a 0 to 6 scale. Scores will be summed to yield a final feasibility score ranging from 0 to 24. Higher scores indicate higher feasibility.'}, {'type': 'PRIMARY', 'title': 'Acceptability of the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brochure', 'description': 'No intervention, brochure'}, {'id': 'OG001', 'title': 'Technology-based Program', 'description': 'technology-based program: Participants will be asked to complete three 25-minute modules covering the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '48.3', 'spread': '7.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 2 weeks of completing the intervention', 'description': 'Participants will complete a survey about the acceptability of the intervention consisting of 10 items rated on a 1 to 5 scale. Higher scores indicated higher acceptability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants will complete a survey about the acceptability of the intervention consisting of 10 items rated on a 1 to 5 scale. Scores will be summed to yield a final feasibility score ranging from 10 to 50. Higher scores indicated higher acceptability.'}, {'type': 'SECONDARY', 'title': 'Change in Perceived Competence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brochure', 'description': 'No intervention, brochure'}, {'id': 'OG001', 'title': 'Technology-based Program', 'description': 'technology-based program: Participants will be asked to complete three 25-minute modules covering the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.'}], 'classes': [{'categories': [{'measurements': [{'value': '.75', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '.3', 'spread': '8.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to within 2 weeks of completing the intervention, up to 5 weeks', 'description': "Participants will complete a survey assessing their feelings of competence related to the information covered by the intervention. The items will be rated on a 1 to 7 scale. Higher scores indicated higher perceived competence. An increase in perceived competence suggests a greater sense of confidence, mastery, and belief in one's ability to achieve goals within that area. This can be linked to positive outcomes like improved performance, motivation, and goal attainment. A decrease in perceived competence indicates a diminished sense of self-efficacy and belief in one's abilities, potentially leading to reduced motivation, avoidance of challenges, and lower engagement.", 'unitOfMeasure': 'mean score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants will complete 12 items (4 items per 3 content areas) assessing their feelings of competence related to the information covered by the intervention. The items will be rated on a 1 to 7 scale. Higher scores indicated higher perceived competence.'}, {'type': 'SECONDARY', 'title': 'Change in Parental Competence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brochure', 'description': 'No intervention, brochure'}, {'id': 'OG001', 'title': 'Technology-based Program', 'description': 'technology-based program: Participants will be asked to complete three 25-minute modules covering the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '9', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '11.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to within 2 weeks of completing the intervention, up to 5 weeks', 'description': "Participants will complete a survey assessing their feelings of competence related to the parenting. The items will be rated on a 1 to 6 scale. An increase in perceived competence suggests a greater sense of confidence, mastery, and belief in one's ability to achieve goals within that area. This can be linked to positive outcomes like improved performance, motivation, and goal attainment. A decrease in perceived competence indicates a diminished sense of self-efficacy and belief in one's abilities, potentially leading to reduced motivation, avoidance of challenges, and lower engagement.", 'unitOfMeasure': 'mean score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants will complete a 16-item survey assessing their feelings of competence related to the parenting. The items will be rated on a 1 to 6 scale. Higher scores indicated higher perceived parental competence.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brochure', 'description': 'No intervention, brochure'}, {'id': 'FG001', 'title': 'Technology-based Program', 'description': 'technology-based program: Participants will be asked to complete three 25-minute modules covering the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'delivered late preterm 34 wks gestation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Brochure', 'description': 'No intervention, brochure'}, {'id': 'BG001', 'title': 'Technology-based Program', 'description': 'technology-based program: Participants will be asked to complete three 25-minute modules covering the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '29.7', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '30', 'spread': '4.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-21', 'size': 800933, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-02T16:08', 'hasProtocol': True}, {'date': '2022-11-07', 'size': 235394, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-30T11:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2022-01-10', 'resultsFirstSubmitDate': '2025-06-02', 'studyFirstSubmitQcDate': '2022-01-27', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-30', 'studyFirstPostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the Intervention', 'timeFrame': 'Within 2 weeks of completing the intervention', 'description': 'Participants will complete a survey about the feasibility of the intervention consisting of 4 items rated on a 0 to 6 scale. Scores will be summed to yield a final feasibility score ranging from 0 to 24. Higher scores indicate higher feasibility.'}, {'measure': 'Acceptability of the Intervention', 'timeFrame': 'Within 2 weeks of completing the intervention', 'description': 'Participants will complete a survey about the acceptability of the intervention consisting of 10 items rated on a 1 to 5 scale. Higher scores indicated higher acceptability.'}], 'secondaryOutcomes': [{'measure': 'Change in Perceived Competence', 'timeFrame': 'Baseline to within 2 weeks of completing the intervention, up to 5 weeks', 'description': "Participants will complete a survey assessing their feelings of competence related to the information covered by the intervention. The items will be rated on a 1 to 7 scale. Higher scores indicated higher perceived competence. An increase in perceived competence suggests a greater sense of confidence, mastery, and belief in one's ability to achieve goals within that area. This can be linked to positive outcomes like improved performance, motivation, and goal attainment. A decrease in perceived competence indicates a diminished sense of self-efficacy and belief in one's abilities, potentially leading to reduced motivation, avoidance of challenges, and lower engagement."}, {'measure': 'Change in Parental Competence', 'timeFrame': 'Baseline to within 2 weeks of completing the intervention, up to 5 weeks', 'description': "Participants will complete a survey assessing their feelings of competence related to the parenting. The items will be rated on a 1 to 6 scale. An increase in perceived competence suggests a greater sense of confidence, mastery, and belief in one's ability to achieve goals within that area. This can be linked to positive outcomes like improved performance, motivation, and goal attainment. A decrease in perceived competence indicates a diminished sense of self-efficacy and belief in one's abilities, potentially leading to reduced motivation, avoidance of challenges, and lower engagement."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test a new educational technology-based program and brochure as a supplement to prenatal education from providers. The program provides education about common challenges that pregnant and parenting women receiving medication for Opioid Use Disorder (OUD) often face. Specifically, it addresses the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant females', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female\n2. ≥18 years of age\n3. Meet criteria for Opioid Use Disorder\n4. Currently receiving MOUD pharmacotherapy (including buprenorphine, buprenorphine/naloxone, or methadone)\n5. Pregnant (\\<34 weeks EGA)\n6. Initial in-person visit at OB MOTIVATE clinic for the current pregnancy ≤10 weeks ago\n\nExclusion Criteria:\n\n1. Considering/planning adoption\n2. Present with a serious cognitive/psychiatric impairment\n3. Existing language barriers making true informed consent impossible'}, 'identificationModule': {'nctId': 'NCT05214118', 'acronym': 'BETTER', 'briefTitle': 'Bringing Education Through Technology, Empathic Listening, and Research', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Project BETTER: Bringing Education Through Technology, Empathic Listening, and Research - A Feasibility Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HM20023314'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Brochure'}, {'type': 'EXPERIMENTAL', 'label': 'Technology-based program', 'interventionNames': ['Behavioral: technology-based program']}], 'interventions': [{'name': 'technology-based program', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to complete three 25-minute modules covering the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.', 'armGroupLabels': ['Technology-based program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Caitlin E Martin, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}