Quality of Life Clinical Trial
Official title:
Growing Together: Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas
Verified date | October 2023 |
Source | University of Arkansas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 10 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Women incarcerated in Arkansas state prison system - 18 years or older - Able to give informed consent - Pregnant or has given birth in past year Exclusion Criteria: - Under 18 years of age |
Country | Name | City | State |
---|---|---|---|
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
University of Arkansas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Program Utilization | % of eligible women who choose to enroll in each program component | Up to 12 months after delivery | |
Primary | Program Acceptability | Self-report ratings of the acceptability of each program component | Up to 12 months after delivery | |
Secondary | Depressive Symptoms | Self-report scores on Patient Health Questionnaire (PHQ-9) | Up to 12 months after delivery | |
Secondary | Depressive Symptoms | Self-report scores on the Edinburgh Postnatal Depression Scale | Up to 12 months after delivery | |
Secondary | PTSD Symptoms | Self-report scores on PTSD Checklist (PCL-5) | Up to 12 months after delivery | |
Secondary | Drug Use | Binary self-report for common classes of drugs | Up to 12 months after delivery | |
Secondary | Health-Related Quality of Life | Self-report scores on Quality of Life Scale (QOLS) | Up to 12 months after delivery | |
Secondary | Health-Related Quality of Life | Self-report scores on the EQ-5D-5L | Up to 12 months after delivery | |
Secondary | Social Support | Self-report scores on Multidimensional Scale of Perceived Social Support | Up to 12 months after delivery | |
Secondary | Parental Stress | Self-report scores on the Parenting Stress Index | Up to 12 months after delivery | |
Secondary | Parental Sense of Competence | Self-report scores on the Parenting Sense of Competence Scale | Up to 12 months after delivery | |
Secondary | Pregnancy Complications | Chart review to determine presence/absence of common pregnancy complications | 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 | |
Secondary | Childbirth Complications | Chart review to determine presence/absence of common pregnancy complications | Up to 12 months after delivery |
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