Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT07165860
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial to Reduce Perinatal Intimate Partner Violence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059037', 'term': 'Doulas'}, {'id': 'D009538', 'term': 'Nicotine'}], 'ancestors': [{'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'The trial will be blinded to the investigators and participants will be unblinded if a participant is experiencing distress or needs support from the primary investigator'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 326}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-09-02', 'studyFirstSubmitQcDate': '2025-09-02', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Resource utilization', 'timeFrame': 'baseline, 3 months, 6 months, 12 months', 'description': '21 items; investigator developed examining utilization of local and national community-based resources; answer choices are yes and no'}, {'measure': 'Safety related empowerment', 'timeFrame': 'baseline, 3 months, 6 months, 12 months', 'description': '13 item Measures of Victim Empowerment Related to Safety survey; α=0.87, answer choices 0 to 4, summary score created, higher score means more empowerment'}, {'measure': 'Trust of healthcare, doula and IPV advocate', 'timeFrame': 'baseline, 3 months, 6 months, 12 months', 'description': '3 item investigator developed, answer choices 0 to 4. Each item analyzed separately (doula, IPV advocate, and physician)'}, {'measure': 'Social support', 'timeFrame': 'baseline, 3 months, 6 months, 12 months', 'description': '12 item Multidimensional Scale of Perceived Social Support; α=0.93. Likert scale 1 to 7, summary score created, higher score means more feelings of social support'}, {'measure': 'Everyday Discrimination', 'timeFrame': 'baseline and 12 months', 'description': '9-item Everyday Discrimination Scale; α=0.84. Answers scores on Likert scale, 0 to 5, summary score created, higher score means more experiences of discrimination. Scale ranges from 10 to 60'}, {'measure': 'Major discrimination', 'timeFrame': 'baseline and 12 months', 'description': '9 item scale on experiences of major discrimination, answer choices yes or no, more yes answer choices means more experiences of major discrimination'}, {'measure': 'Sleep coercion (lifetime)', 'timeFrame': 'baseline', 'description': '1 item sleep coercion measure (investigator developed, yes/no)'}, {'measure': 'Reproductive Coercion (lifetime)', 'timeFrame': 'baseline', 'description': '9 item reproductive coercion scale (answer choices yes/no). More yes responses means more experiences of reproductive coercion'}, {'measure': 'Economic Abuse (lifetime)', 'timeFrame': 'baseline', 'description': '12 item Revised Scale of Economic Abuse (answer choices yes or no), more yes responses means more experiences of economic abuse'}, {'measure': 'Mental health coercion (lifetime)', 'timeFrame': 'baseline', 'description': '5 item mental health coercion survey with yes and no answer choices'}, {'measure': 'Lifetime substance use coercion', 'timeFrame': 'baseline', 'description': '5 item measure answer choices and yes/no'}, {'measure': 'Lifetime physical, sexual, or emotional abuse', 'timeFrame': 'baseline', 'description': '15 item Composite Abuse Scale Short form, scale is 0 to 5 and 15 items are added for a summary score, higher number means more IPV'}, {'measure': 'Self-efficacy', 'timeFrame': 'baseline, 3, 6 and 12 months', 'description': 'Validated 8 item New General Self Efficacy Scale. Likert scale 1 to 5, summary scale created, a higher score means more self-efficacy. The score ranges from 10 to 40'}, {'measure': 'Parenting Stress', 'timeFrame': '6 months, 12 months', 'description': 'Validated Parenting Stress Scale; 18 items; Likert Scale 1 to 5, summary score created, a higher score means more parenting stress. The range is 18 to 90'}], 'primaryOutcomes': [{'measure': 'Perinatal physical, sexual, or emotional abuse (past 3 months)', 'timeFrame': 'baseline, 3 months, 6 months, 12 months', 'description': '15 item Composite Abuse Scale Short form, scale is 0 to 5 and 15 items are added for a summary score, higher number means more IPV'}, {'measure': 'Substance use coercion (past 3 month)', 'timeFrame': 'baseline, 3 months, 6 months, and 12 months', 'description': '5 item measure answer choices and yes/no'}, {'measure': 'Mental health coercion (past 3 month)', 'timeFrame': 'baseline, 3 months, 6 months, and 12 months', 'description': '5 item mental health coercion survey with yes and no answer choices'}, {'measure': 'Economic Abuse (past 3 month)', 'timeFrame': 'baseline, 3 month, 6 months, and 12 months', 'description': '12 item Revised Scale of Economic Abuse (answer choices yes or no), more yes responses means more experiences of economic abuse'}, {'measure': 'Reproductive Coercion (past 3 months)', 'timeFrame': 'baseline, 3 months, 6 months, and 12 months', 'description': '9 item reproductive coercion scale (answer choices yes/no). More yes responses means more experiences of reproductive coercion'}, {'measure': 'Sleep coercion (past 3 months)', 'timeFrame': 'baseline, 3 months, 6 months, and 12 months', 'description': '1 item sleep coercion measure (investigator developed, yes/no)'}], 'secondaryOutcomes': [{'measure': 'Substance use', 'timeFrame': 'baseline', 'description': '4 item validated measure to assess substance use during pregnancy'}, {'measure': 'Tobacco use', 'timeFrame': 'baseline, 3 months, 6 months, 12 months', 'description': 'Type, frequency, use currently and before pregnancy (4 items)'}, {'measure': 'Depressive symptoms', 'timeFrame': 'baseline, 3 months, 6 months, 12 months', 'description': '10 item Edinburgh Postnatal Depression Scale; α=0.87, summary scale and mean, higher score means more depression. Scale ranges from 0 to 30'}, {'measure': 'Anxiety', 'timeFrame': 'baseline, 3 months, 6 months, and 12 months', 'description': '7 item validated GAD-7, scores Likert 0 to 3, added up for summary scale, higher score means more anxiety. Scale ranges from 0 to 21'}, {'measure': 'Unmet basic needs (financial, food, and housing insecurity)', 'timeFrame': 'Baseline, 12 months', 'description': '5 item investigator developed scale on food, housing, and utilities insecurity. Answer choices yes or no, more yes choices chosen means more unmet basic needs'}, {'measure': 'Past 3-month substance use', 'timeFrame': '6 months, 12 months', 'description': 'Substances used in the past 3 months, first yes/no and then type of substance'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intimate partner violence', 'perinatal health', 'doula'], 'conditions': ['Domestic Violence', 'Perinatal Problems']}, 'descriptionModule': {'briefSummary': 'This is a two-armed, fully powered hybrid type 1 trial to test the effectiveness of a doula intervention compared with an active control in reducing intimate partner violence (IPV) among perinatal IPV survivors', 'detailedDescription': 'The study team will complete a 2-arm randomized clinical trial to test the effectiveness of IPV-trained doulas compared with an active control in reducing IPV among perinatal IPV survivors. Participants randomized into doula group will be paired community doula who will provide full-spectrum doula services prenatally (22 weeks gestation), through the birthing period, to early postpartum (6 months total). Participants randomized to the active two structured intakes from a victim services agency. Participants will be recruited from their prenatal visit at 1 of 3 sites with 163 perinatal people randomized to the doula group and 163 randomized to active control (N=326). The primary outcome is change in IPV across a range coercive behaviors from baseline to 12-months post enrollment. Secondary outcomes include change in cannabis and tobacco use, as well as depressive symptoms, anxiety, and unmet basic needs. The study will also be assessing changes in intermediate outcomes, including resource utilization, trust of doulas and IPV advocates, parenting stress, safety-related empowerment, and social support. Measures will be completed at enrollment, and then 3-, 6-, and 12-months post-enrollment. In Aim 2, the study team will be assessing potential mediators and moderators driving intervention effects and in Aim 3, collecting information about implementation outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Perinatal IPV survivors are eligible if they:\n\n* 1\\) feel comfortable completing the study in Spanish or English\n* 2\\) are age 18 or older\n* 3\\) are no more than 22 weeks gestation\n* 4\\) identify as an IPV survivor by answering affirmatively to a definition of experiencing IPV\n* 5\\) live within a 50 mile radius of Pittsburgh, Pennsylvania\n* 6\\) able to provide safe and complete contact information or take a study cell phone\n\nExclusion Criteria:\n\n* Unable to consent\n* Do not meet inclusion criteria\n* Cannot provide safe contact information or take a study cell phone\n* Incarcerated'}, 'identificationModule': {'nctId': 'NCT07165860', 'briefTitle': 'Clinical Trial to Reduce Perinatal Intimate Partner Violence', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Novel Doula Intervention to Leverage Clinic-community Connections to Support Perinatal Intimate Partner Violence Survivors', 'orgStudyIdInfo': {'id': 'STUDY24080042'}, 'secondaryIdInfos': [{'id': 'R01NR021484', 'link': 'https://reporter.nih.gov/quickSearch/R01NR021484', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active control arm', 'description': 'The active control arm will include two structured check-ins by a trained intimate partner violence advocate from a local victim services agency. The IPV advocate will check in twice: once prenatally (after randomization) and the next postpartum. All participants in the active control arm will have access to the 24/7 helpline.', 'interventionNames': ['Behavioral: Thrive']}, {'type': 'EXPERIMENTAL', 'label': 'Doula group (intervention)', 'description': "The intervention arm will include support rom a community-based doula connected with an IPV survivor during the second trimester and followed for 6 months. The doulas will provide full-spectrum services, which include attending clinic visits, support during the delivery, telephone and virtual check-ins, and connection to resources. Doulas have 4 structured visits (4 hours) and the rest of the time will be unstructured. Doulas will also attend the participant's birth. Doulas will provide a trauma-informed perinatal workbook to the participants that our team developed.", 'interventionNames': ['Behavioral: Doulas']}], 'interventions': [{'name': 'Doulas', 'type': 'BEHAVIORAL', 'description': 'The intervention will be pairing intimate partner violence survivors with a trained doula', 'armGroupLabels': ['Doula group (intervention)']}, {'name': 'Thrive', 'type': 'BEHAVIORAL', 'description': 'The active control arm will include pairing intimate partner violence survivors with IPV advocates', 'armGroupLabels': ['Active control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Judy Chang', 'role': 'CONTACT', 'email': 'chanjc@upmc.edu'}], 'facility': "Magee Women's Hospital", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15222', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily McGahey', 'role': 'CONTACT', 'email': 'e.mcgahey@midwifecenter.org', 'phone': '(412) 321-6880'}], 'facility': 'The Midwife Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15260', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stacy Bartlett', 'role': 'CONTACT', 'email': 'bartlettsj2@upmc.edu', 'phone': '412-383-2377'}], 'facility': 'Family Medicine Department', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Maya Ragavan', 'role': 'CONTACT', 'email': 'ragavanm@chp.edu', 'phone': '4126926545'}, {'name': 'Maya Ragavan', 'role': 'CONTACT', 'email': 'ragavanm@chp.edu', 'phone': '16506449954'}], 'overallOfficials': [{'name': 'Maya I Ragavan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Dara Mendez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual level data will be shared outside of our team. Aggregated data may be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Maya Ragavan', 'investigatorAffiliation': 'University of Pittsburgh'}}}}