<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04421235</url>
  </required_header>
  <id_info>
    <org_study_id>260265</org_study_id>
    <secondary_id>PTC2020-02</secondary_id>
    <nct_id>NCT04421235</nct_id>
  </id_info>
  <brief_title>Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas</brief_title>
  <official_title>Growing Together: Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arkansas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The number of women who are incarcerated in the U.S. has increased dramatically over the past&#xD;
      20 years-over 750%, or from 13,258 in 1980 to 111,616 in 2016. Arkansas incarcerates 92 women&#xD;
      per 100,000 population compared to 57 per 100,000 average across all states, ranking the&#xD;
      state as the 8th highest in the nation. Over 75% of incarcerated women are of childbearing&#xD;
      age and about 4% are pregnant upon intake. However, little is known about the population of&#xD;
      women who have become incarcerated while pregnant in Arkansas - including the outcomes of&#xD;
      these women and their children and how these outcomes may vary in relation to services that&#xD;
      are received during incarceration. This research study aims to first expand knowledge on&#xD;
      incarcerated women in Arkansas by using administrative data to retrospectively examine the&#xD;
      health status and outcomes of pregnant women who were incarcerated in state prison by&#xD;
      Arkansas from June 1, 2014 to May 31, 2019 (a five-year cohort; Aim 1). Then, we will lay the&#xD;
      groundwork for and subsequently analyze data on outcomes and perspectives of women who have&#xD;
      been incarcerated in Arkansas while pregnant (Aims 2 and 3). We will also seek to understand&#xD;
      the feasibility and acceptability of elements of an enhanced support program for incarcerated&#xD;
      pregnant women recently launched via a collaboration between Arkansas Department of&#xD;
      Corrections and UAMS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">November 19, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Program Utilization</measure>
    <time_frame>Up to 12 months after delivery</time_frame>
    <description>% of eligible women who choose to enroll in each program component</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Program Acceptability</measure>
    <time_frame>Up to 12 months after delivery</time_frame>
    <description>Self-report ratings of the acceptability of each program component</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depressive Symptoms</measure>
    <time_frame>Up to 12 months after delivery</time_frame>
    <description>Self-report scores on Patient Health Questionnaire (PHQ-9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive Symptoms</measure>
    <time_frame>Up to 12 months after delivery</time_frame>
    <description>Self-report scores on the Edinburgh Postnatal Depression Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTSD Symptoms</measure>
    <time_frame>Up to 12 months after delivery</time_frame>
    <description>Self-report scores on PTSD Checklist (PCL-5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug Use</measure>
    <time_frame>Up to 12 months after delivery</time_frame>
    <description>Binary self-report for common classes of drugs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-Related Quality of Life</measure>
    <time_frame>Up to 12 months after delivery</time_frame>
    <description>Self-report scores on Quality of Life Scale (QOLS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-Related Quality of Life</measure>
    <time_frame>Up to 12 months after delivery</time_frame>
    <description>Self-report scores on the EQ-5D-5L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Support</measure>
    <time_frame>Up to 12 months after delivery</time_frame>
    <description>Self-report scores on Multidimensional Scale of Perceived Social Support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental Stress</measure>
    <time_frame>Up to 12 months after delivery</time_frame>
    <description>Self-report scores on the Parenting Stress Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental Sense of Competence</measure>
    <time_frame>Up to 12 months after delivery</time_frame>
    <description>Self-report scores on the Parenting Sense of Competence Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy Complications</measure>
    <time_frame>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</time_frame>
    <description>Chart review to determine presence/absence of common pregnancy complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Childbirth Complications</measure>
    <time_frame>Up to 12 months after delivery</time_frame>
    <description>Chart review to determine presence/absence of common pregnancy complications</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Health Problems in Pregnancy</condition>
  <condition>Childbirth Problems</condition>
  <condition>Maternal Care Patterns</condition>
  <condition>Quality of Life</condition>
  <condition>Emotional Stress</condition>
  <condition>Health Care Acceptability</condition>
  <condition>Health Risk Behaviors</condition>
  <condition>Parent-Child Relations</condition>
  <arm_group>
    <arm_group_label>Childbirth Support</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Childbirth support</intervention_name>
    <description>There are 5 program components that women may receive as a part of childbirth support:&#xD;
Prenatal education - consists of up to 8 sessions of education on pregnancy, childbirth, and postpartum health and wellness.&#xD;
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.&#xD;
Lactation program - program for women who wish to provide breastmilk for infants from which they are separated.&#xD;
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.&#xD;
Parenting classes - group classes focused on helping women learn parenting skills and (if applicable) meet state requirements for reunification with children</description>
    <arm_group_label>Childbirth Support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women incarcerated in Arkansas state prison system&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Pregnant or has given birth in past year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melissa Zielinski, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arkansas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 20, 2023</last_update_submitted>
  <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Incarcerated Women</keyword>
  <keyword>Prison</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04421235
org study id: 260265
secondary id: PTC2020-02
nct id: NCT04421235
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Program Utilization
time frame: Up to 12 months after delivery
description: % of eligible women who choose to enroll in each program component
measure: Program Acceptability
time frame: Up to 12 months after delivery
description: Self-report ratings of the acceptability of each program component
measure: Depressive Symptoms
time frame: Up to 12 months after delivery
description: Self-report scores on Patient Health Questionnaire (PHQ-9)
measure: Depressive Symptoms
time frame: Up to 12 months after delivery
description: Self-report scores on the Edinburgh Postnatal Depression Scale
measure: PTSD Symptoms
time frame: Up to 12 months after delivery
description: Self-report scores on PTSD Checklist (PCL-5)
measure: Drug Use
time frame: Up to 12 months after delivery
description: Binary self-report for common classes of drugs
measure: Health-Related Quality of Life
time frame: Up to 12 months after delivery
description: Self-report scores on Quality of Life Scale (QOLS)
measure: Health-Related Quality of Life
time frame: Up to 12 months after delivery
description: Self-report scores on the EQ-5D-5L
measure: Social Support
time frame: Up to 12 months after delivery
description: Self-report scores on Multidimensional Scale of Perceived Social Support
measure: Parental Stress
time frame: Up to 12 months after delivery
description: Self-report scores on the Parenting Stress Index
measure: Parental Sense of Competence
time frame: Up to 12 months after delivery
description: Self-report scores on the Parenting Sense of Competence Scale
measure: Pregnancy Complications
time frame: 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
time frame: Up to 12 months after delivery
description: Chart review to determine presence/absence of common pregnancy complications
arm group label: Childbirth Support
arm group type: Other
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.
intervention type: Behavioral
intervention name: Childbirth support
description: 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
arm group label: Childbirth Support
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Melissa Zielinski, PhD
role: Principal Investigator
affiliation: University of Arkansas
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No