Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas

Sponsor
University of Arkansas (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04421235
Collaborator
(none)
500
1
1
13.4
37.4

Study Details

Study Description

Brief Summary

Incarcerated pregnant women are a largely invisible special population with great need for health care and advocacy. The number of women who are incarcerated in the U.S. has increased over 750%, or from 13,258 in 1980 to 111,616 in 2016. Arkansas has the 8th highest number of incarcerated women in the nation, 60% higher than the national average. As the number of incarcerated women has risen, so too has the need for jails and prisons to address women's health needs, including pregnancy, childbirth, and postpartum care. Nationally, over 75% of incarcerated women are of childbearing age and about 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 over a five-year period (Aim 1). Then, the investigators will lay the groundwork for and subsequently analyze prospectively gathered outcomes of women in Arkansas state prisons by supplementing administratively-collected data with in-person data collection (Aim 2). This prospectively-gathered data will include records of: 1) self-report responses to surveys about their health and mental health, 2) women's participation or nonparticipation in elements of programming for incarcerated pregnant women that was recently launched by Arkansas Department of Correction in collaboration with the study PI (i.e., Growing Together), and 3) self-report responses to surveys about the elements of Growing Together. The Growing Together program elements that are currently active and that will be evaluated under this protocol are a lactation program, lactation education, and a mental health support group. The investigators will also pilot and conduct an open-label evaluation of an additional program component, doula support, with a sample of up to 24 incarcerated women (Aim 3). Assessment of the program components in Aims 2 and 3 will focus on evaluating acceptability to the population and feasibility.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Growing Together: Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas
Actual Study Start Date :
Nov 19, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Childbirth Support

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.

Behavioral: Childbirth support
There are 5 program components that women may receive as a part of childbirth support: Prenatal education - consists of up to 8 sessions of education on pregnancy, childbirth, and postpartum health and wellness. Support 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. Lactation program - program for women who wish to provide breastmilk for infants from which they are separated. Doula 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. Parenting classes - group classes focused on helping women learn parenting skills and (if applicable) meet state requirements for reunification with children

Outcome Measures

Primary Outcome Measures

  1. Program Utilization [Up to 12 months after delivery]

    % of eligible women who choose to enroll in each program component

  2. Program Acceptability [Up to 12 months after delivery]

    Self-report ratings of the acceptability of each program component

Secondary Outcome Measures

  1. Depressive Symptoms [Up to 12 months after delivery]

    Self-report scores on Patient Health Questionnaire (PHQ-9)

  2. Depressive Symptoms [Up to 12 months after delivery]

    Self-report scores on the Edinburgh Postnatal Depression Scale

  3. PTSD Symptoms [Up to 12 months after delivery]

    Self-report scores on PTSD Checklist (PCL-5)

  4. Drug Use [Up to 12 months after delivery]

    Binary self-report for common classes of drugs

  5. Health-Related Quality of Life [Up to 12 months after delivery]

    Self-report scores on Quality of Life Scale (QOLS)

  6. Health-Related Quality of Life [Up to 12 months after delivery]

    Self-report scores on the EQ-5D-5L

  7. Social Support [Up to 12 months after delivery]

    Self-report scores on Multidimensional Scale of Perceived Social Support

  8. Parental Stress [Up to 12 months after delivery]

    Self-report scores on the Parenting Stress Index

  9. Parental Sense of Competence [Up to 12 months after delivery]

    Self-report scores on the Parenting Sense of Competence Scale

  10. 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]

    Chart review to determine presence/absence of common pregnancy complications

  11. Childbirth Complications [Up to 12 months after delivery]

    Chart review to determine presence/absence of common pregnancy complications

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205

Sponsors and Collaborators

  • University of Arkansas

Investigators

  • Principal Investigator: Melissa Zielinski, PhD, University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT04421235
Other Study ID Numbers:
  • 260265
  • PTC2020-02
First Posted:
Jun 9, 2020
Last Update Posted:
Dec 8, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Arkansas

Study Results

No Results Posted as of Dec 8, 2021