- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04421235
Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas
Growing Together: Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Program Utilization
Time Frame: Up to 12 months after delivery
|
% of eligible women who choose to enroll in each program component
|
Up to 12 months after delivery
|
Program Acceptability
Time Frame: Up to 12 months after delivery
|
Self-report ratings of the acceptability of each program component
|
Up to 12 months after delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depressive Symptoms
Time Frame: Up to 12 months after delivery
|
Self-report scores on Patient Health Questionnaire (PHQ-9)
|
Up to 12 months after delivery
|
Depressive Symptoms
Time Frame: Up to 12 months after delivery
|
Self-report scores on the Edinburgh Postnatal Depression Scale
|
Up to 12 months after delivery
|
PTSD Symptoms
Time Frame: Up to 12 months after delivery
|
Self-report scores on PTSD Checklist (PCL-5)
|
Up to 12 months after delivery
|
Drug Use
Time Frame: Up to 12 months after delivery
|
Binary self-report for common classes of drugs
|
Up to 12 months after delivery
|
Health-Related Quality of Life
Time Frame: Up to 12 months after delivery
|
Self-report scores on Quality of Life Scale (QOLS)
|
Up to 12 months after delivery
|
Health-Related Quality of Life
Time Frame: Up to 12 months after delivery
|
Self-report scores on the EQ-5D-5L
|
Up to 12 months after delivery
|
Social Support
Time Frame: Up to 12 months after delivery
|
Self-report scores on Multidimensional Scale of Perceived Social Support
|
Up to 12 months after delivery
|
Parental Stress
Time Frame: Up to 12 months after delivery
|
Self-report scores on the Parenting Stress Index
|
Up to 12 months after delivery
|
Parental Sense of Competence
Time Frame: Up to 12 months after delivery
|
Self-report scores on the Parenting Sense of Competence Scale
|
Up to 12 months after delivery
|
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
|
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
|
Childbirth Complications
Time Frame: Up to 12 months after delivery
|
Chart review to determine presence/absence of common pregnancy complications
|
Up to 12 months after delivery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Melissa Zielinski, Phd, University of Arkansas
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 260265
- PTC2020-02 (Other Grant/Funding Number: UAMS Translational Research Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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