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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04421235
• Other study ID #: 260265
• Secondary ID: PTC2020-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 19, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Childbirth Problems
• Emotional Stress
• Health Care Acceptability
• Health Problems in Pregnancy
• Health Risk Behaviors
• Maternal Care Patterns
• Parent-Child Relations
• Quality of Life

Intervention

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

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

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