Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-29 @ 7:14 PM
Study NCT ID:
NCT04421235
Status:
COMPLETED
Last Update Posted:
2025-07-22
First Post:
2020-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000073599', 'term': 'Health Risk Behaviors'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2020-05-27', 'studyFirstSubmitQcDate': '2020-06-05', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Program Utilization', 'timeFrame': 'Up to 12 months after delivery', 'description': '% of eligible women who choose to enroll in each program component'}, {'measure': 'Program Acceptability', 'timeFrame': 'Up to 12 months after delivery', 'description': 'Self-report ratings of the acceptability of each program component'}], 'secondaryOutcomes': [{'measure': 'Depressive Symptoms', 'timeFrame': 'Up to 12 months after delivery', 'description': 'Self-report scores on Patient Health Questionnaire (PHQ-9)'}, {'measure': 'Depressive Symptoms', 'timeFrame': 'Up to 12 months after delivery', 'description': 'Self-report scores on the Edinburgh Postnatal Depression Scale'}, {'measure': 'PTSD Symptoms', 'timeFrame': 'Up to 12 months after delivery', 'description': 'Self-report scores on PTSD Checklist (PCL-5)'}, {'measure': 'Drug Use', 'timeFrame': 'Up to 12 months after delivery', 'description': 'Binary self-report for common classes of drugs'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': 'Up to 12 months after delivery', 'description': 'Self-report scores on Quality of Life Scale (QOLS)'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': 'Up to 12 months after delivery', 'description': 'Self-report scores on the EQ-5D-5L'}, {'measure': 'Social Support', 'timeFrame': 'Up to 12 months after delivery', 'description': 'Self-report scores on Multidimensional Scale of Perceived Social Support'}, {'measure': 'Parental Stress', 'timeFrame': 'Up to 12 months after delivery', 'description': 'Self-report scores on the Parenting Stress Index'}, {'measure': 'Parental Sense of Competence', 'timeFrame': 'Up to 12 months after delivery', 'description': 'Self-report scores on the Parenting Sense of Competence Scale'}, {'measure': 'Pregnancy Complications', 'timeFrame': 'From the date of enrollment until the date of childbirth or the date of pregnancy loss or termination, whichever came first, assessed up to 50 weeks', 'description': 'Chart review to determine presence/absence of common pregnancy complications'}, {'measure': 'Childbirth Complications', 'timeFrame': 'Up to 12 months after delivery', 'description': 'Chart review to determine presence/absence of common pregnancy complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Incarcerated Women', 'Prison'], 'conditions': ['Health Problems in Pregnancy', 'Childbirth Problems', 'Maternal Care Patterns', 'Quality of Life', 'Emotional Stress', 'Health Care Acceptability', 'Health Risk Behaviors', 'Parent-Child Relations']}, 'descriptionModule': {'briefSummary': 'The number of women who are incarcerated in the U.S. has increased dramatically over the past 20 years-over 750%, or from 13,258 in 1980 to 111,616 in 2016. Arkansas incarcerates 92 women per 100,000 population compared to 57 per 100,000 average across all states, ranking the state as the 8th highest in the nation. Over 75% of incarcerated women are of childbearing age and about 4% are pregnant upon intake. However, little is known about the population of women who have become incarcerated while pregnant in Arkansas - including the outcomes of these women and their children and how these outcomes may vary in relation to services that are received during incarceration. This research study aims to first expand knowledge on incarcerated women in Arkansas by using administrative data to retrospectively examine the health status and outcomes of pregnant women who were incarcerated in state prison by Arkansas from June 1, 2014 to May 31, 2019 (a five-year cohort; Aim 1). Then, we will lay the groundwork for and subsequently analyze data on outcomes and perspectives of women who have been incarcerated in Arkansas while pregnant (Aims 2 and 3). We will also seek to understand the feasibility and acceptability of elements of an enhanced support program for incarcerated pregnant women recently launched via a collaboration between Arkansas Department of Corrections and UAMS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of administrative data on women who were: 1) incarcerated in the Hawkins Unit at Wrightsville Prison between June 1, 2014 to May 31, 2019 (a five-year cohort prior to initiation of Growing Together) and 2) who received pre- and/or post-natal health care services during that incarceration.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women incarcerated in Arkansas state prison system\n* 18 years or older\n* Able to give informed consent\n* Pregnant or has given birth in past year\n\nExclusion Criteria:\n\n* Under 18 years of age'}, 'identificationModule': {'nctId': 'NCT04421235', 'briefTitle': 'Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Growing Together: Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas', 'orgStudyIdInfo': {'id': '260265'}, 'secondaryIdInfos': [{'id': 'UL1TR003107', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR003107', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Childbirth Support', 'description': 'Women who enroll in the intervention portion of this study will receive the childbirth support elements for which they are eligible in and elect to participate. Possible program elements include prenatal education classes, support group, lactation program, doula support, and parenting classes.', 'interventionNames': ['Behavioral: Childbirth support']}], 'interventions': [{'name': 'Childbirth support', 'type': 'BEHAVIORAL', 'description': 'There are 5 program components that women may receive as a part of childbirth support:\n\nPrenatal education - consists of up to 8 sessions of education on pregnancy, childbirth, and postpartum health and wellness.\n\nSupport group - semi-structured group which provides time for women to process their pregnancy and postpartum-related experiences with other women facing similar challenges. Integrates mindfulness exercises, cognitive-behavioral skills, and special topics as requested by group members.\n\nLactation program - program for women who wish to provide breastmilk for infants from which they are separated.\n\nDoula support program - 2 prenatal and 2 postnatal individual visits with a doula who will also provide continuous childbirth support and support during separation from infants.\n\nParenting classes - group classes focused on helping women learn parenting skills and (if applicable) meet state requirements for reunification with children', 'armGroupLabels': ['Childbirth Support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Melissa Zielinski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}