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Reducing Stress-Sensitive Problems Among Pregnant Black Women With Childhood Adversity

Primary Purpose

Maternal Psychological Distress, Childhood Trauma, Health Behavior

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma Informed Prenatal Intervention (TPI)
Prenatal Education Topics
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maternal Psychological Distress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: receiving prenatal care at Mile Square Health Center or University of Illinois Health age >/= 18 years >/= 2 adverse childhood experiences Black race English-speaking 10-24 weeks gestation able to attend four sessions owner of a smart phone and access to internet Exclusion Criteria: inability to reliably or safely participate in the study due to self-reported serious or persistent mental health disorder (e.g., schizophrenia or bipolar disorder), which could also interfere with study adherence.

Sites / Locations

  • Mile Square Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trauma Informed Prenatal Intervention (TPI)

Prenatal Education Topics

Arm Description

The experimental arm consists of four weekly, individual (45-60 minute) sessions via Zoom with a research staff member facilitating motivational interviewing focused on behavior change and mindfulness awareness practice.

The active comparator arm consists of four weekly, individual (30-minute) sessions via Zoom with a research staff member delivering prenatal education topics consisting of lecture (power point slides) and video.

Outcomes

Primary Outcome Measures

Change in Edinburgh Postnatal Depression Scale at 6-weeks postnatal
The Edinburgh Postnatal Depression Scale (range: 0-30) is a 10-item scale is a pregnancy and/or postpartum depression screen that assesses different emotions in the past seven days in which a higher score indicates a worse outcome.

Secondary Outcome Measures

Change in Generalized Anxiety Disorder Scale at 6-weeks postnatal
Generalized Anxiety Disorder Scale (range: 0-21) is a 7-item scale that assesses the frequency of excessive, uncontrollable worry in the past two-weeks in which a higher score indicates a worse outcome regarding life events or activities in which a higher score signifies a worse outcome.
Change in Perceived Stress Scale at 6-weeks postnatal
The Perceived Stress Scale (range: 0-40) is a 10-item scale that assesses the frequency of stressful thoughts and feelings in the last one month in which a higher score indicates a worse outcome.
Change in Behavioral Activation Scale at 6-weeks postnatal
The Behavioral Activation Scale (range: 0-54) is a 9-item scale that assesses avoidance or engagement in goal-directed activity and pleasant behaviors during the past one week in which a higher score indicates a better outcome.
Negative Mood Regulation Short Form Scale at 6-weeks postnatal
The Negative Mood Regulation Scale (range: 15-75) is a 15-item scale that assesses the capacity for calming and soothing emotions when one is upset in which a higher score indicates a better outcome.
Change in Five Facet Mindfulness Questionnaire at 6-weeks postnatal
The Five Facet Mindfulness Questionnaire (range: 15-75) is a 15-item scale that assesses the frequency of a general tendency to be self-aware and mindful in everyday life in which a higher score indicates a better outcome.
Change in Prenatal Health Behaviors at 6-weeks postnatal
The Prenatal Health Behaviors Scale (range: 0-96) is a 24-item scale that assesses the frequency of the use of prenatal health behaviors, including smoking, alcohol, drugs, food, vitamins, physical activity, sleep, etc in which a higher score signifies a worse outcome.

Full Information

First Posted
December 1, 2022
Last Updated
May 8, 2023
Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05718479
Brief Title
Reducing Stress-Sensitive Problems Among Pregnant Black Women With Childhood Adversity
Official Title
Reducing Stress-Sensitive Problems Among Pregnant Black Women With Childhood Adversity: A Pilot Randomized Controlled Trial of Motivational Interviewing and Mental Wellness Skills
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to test the feasibility and acceptability and compare outcomes of a trauma-informed prenatal intervention (TPI) in pregnant Black women with childhood adversity. TPI participants will receive four weekly individual virtual sessions of motivational interviewing to promote self-efficacy and mental wellness skills to enhance self-awareness and self-regulation. TPI is designed to foster behavior change and health coping by enhancing knowledge, beliefs, regulation skills and abilities. With the assistance of a trained facilitator, participants will be guided to identify a specific goal related to the behavior they want to change. Behavior change goals will be individualized to create a change plan that reinforces resilience-based coping, accountability, and self-care rewards. Participants will learn to apply mental wellness skills to enhance regulation and to facilitate awareness of internal cues related to desire, motivation, and individual responses to stress. Researchers will compare usual prenatal care plus TPI versus usual prenatal care plus prenatal education to see if TPI reduces psychological (e.g., depression, anxiety, and perceived stress), and improves socio-emotional (e.g., behavioral activation, negative mood regulation, and mindfulness), and prenatal health behaviors.
Detailed Description
The goal of this research to reduce the impact of maternal adverse childhood experiences (ACEs) on perinatal mental and psychosocial health by providing the necessary tools for the development of healthy coping practices. The purpose of this proposal is to conduct Phase II preliminary testing of an individually randomized pilot trial (N=30) examining feasibility, acceptability, and compare initial estimates of the effects of the primary outcome of depression and secondary outcomes of psychological (e.g., perceived stress, anxiety) and socio-emotional (e.g., behavioral activation, negative mood regulation, mindfulness) functioning and prenatal health behaviors of those allocated to either a trauma-informed prenatal intervention (TPI) (n=15) or the control group, e.g., prenatal education arm, (n=15). Thirty adult, pregnant Black women with >/=2 ACEs receiving prenatal care at one large Federally Qualified Health Center (FQHC), Mile Square, will be enrolled during the second trimester between 12-24 weeks gestation. TPI participants will receive four weekly (30-60 minute) individual online sessions of motivational interviewing to promote self-efficacy and guided mindfulness practice to enhance self-awareness. Patient-reported outcome measures will be collected online at baseline, 4- and 12-weeks post-randomization, and 6-weeks postpartum. The broader implementation potential of identifying, assessing, and addressing ACEs impact in Mile Square Health Center will be explored using interview-administered surveys. A trauma-informed approach within prenatal care services may help reduce maternal distress and its consequences, and, subsequently, lessen the risk for the negative impact of ACEs on maternal and child health. Findings from this study will inform a larger efficacy trial of TPI to improve maternal mental and psychosocial health among pregnant Black women with maternal ACEs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Psychological Distress, Childhood Trauma, Health Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention consists of four weekly individual sessions. In Step One, participants identify ways of coping with stress and create a behavior change plan with measurable goals. An initial 1-hour semi-structured interview provides an opportunity to self-assess motivation to change a health behavior. Step Two facilitates a behavior plan assisting participants to identify a measurable goal, barriers to achieving their goal, strategies to mitigate triggers, social supports, and progress rewards. Sessions 2-4 include a 10-minute check-in to assess the status of targeted behaviors, troubleshoot potential barriers, modify the plan, and reinforce progress followed up with 20-minutes of practicing mindfulness. In Step Three, participants will learn and practice a new type of mindfulness (e.g., breath, body scan, and loving kindness) meditation each week. The final integration phase guides participants to practice while imagining performing a new behavior or having achieved their goal.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trauma Informed Prenatal Intervention (TPI)
Arm Type
Experimental
Arm Description
The experimental arm consists of four weekly, individual (45-60 minute) sessions via Zoom with a research staff member facilitating motivational interviewing focused on behavior change and mindfulness awareness practice.
Arm Title
Prenatal Education Topics
Arm Type
Active Comparator
Arm Description
The active comparator arm consists of four weekly, individual (30-minute) sessions via Zoom with a research staff member delivering prenatal education topics consisting of lecture (power point slides) and video.
Intervention Type
Behavioral
Intervention Name(s)
Trauma Informed Prenatal Intervention (TPI)
Intervention Description
TPI is designed to foster behavior change and health coping by enhancing knowledge, beliefs, regulation skills and abilities. In the experimental group, a research staff member will meet with participants and help them to identify a health behavior they want to change, explore the pros and cons of making a change, create a behavior change plan, and learn several mindfulness meditation techniques. The facilitator will check-in with the participants about their behavior change plan in the subsequent sessions regarding progress made, barriers encountered, and changes in the plan and/or goal going forward. Participants will be instructed to implement an at-home mental wellness skills and provided with a tracking log to report the frequency and dose of daily/weekly practice.
Intervention Type
Other
Intervention Name(s)
Prenatal Education Topics
Intervention Description
In the control group, a research staff member will provide participants with four different weekly prenatal education topics, including information on prenatal care, labor and delivery, postpartum care, and newborn care.
Primary Outcome Measure Information:
Title
Change in Edinburgh Postnatal Depression Scale at 6-weeks postnatal
Description
The Edinburgh Postnatal Depression Scale (range: 0-30) is a 10-item scale is a pregnancy and/or postpartum depression screen that assesses different emotions in the past seven days in which a higher score indicates a worse outcome.
Time Frame
6-weeks postnatal
Secondary Outcome Measure Information:
Title
Change in Generalized Anxiety Disorder Scale at 6-weeks postnatal
Description
Generalized Anxiety Disorder Scale (range: 0-21) is a 7-item scale that assesses the frequency of excessive, uncontrollable worry in the past two-weeks in which a higher score indicates a worse outcome regarding life events or activities in which a higher score signifies a worse outcome.
Time Frame
6-weeks postnatal
Title
Change in Perceived Stress Scale at 6-weeks postnatal
Description
The Perceived Stress Scale (range: 0-40) is a 10-item scale that assesses the frequency of stressful thoughts and feelings in the last one month in which a higher score indicates a worse outcome.
Time Frame
6-weeks postnatal
Title
Change in Behavioral Activation Scale at 6-weeks postnatal
Description
The Behavioral Activation Scale (range: 0-54) is a 9-item scale that assesses avoidance or engagement in goal-directed activity and pleasant behaviors during the past one week in which a higher score indicates a better outcome.
Time Frame
6-weeks postnatal
Title
Negative Mood Regulation Short Form Scale at 6-weeks postnatal
Description
The Negative Mood Regulation Scale (range: 15-75) is a 15-item scale that assesses the capacity for calming and soothing emotions when one is upset in which a higher score indicates a better outcome.
Time Frame
6-weeks postnatal
Title
Change in Five Facet Mindfulness Questionnaire at 6-weeks postnatal
Description
The Five Facet Mindfulness Questionnaire (range: 15-75) is a 15-item scale that assesses the frequency of a general tendency to be self-aware and mindful in everyday life in which a higher score indicates a better outcome.
Time Frame
6-weeks postpartum
Title
Change in Prenatal Health Behaviors at 6-weeks postnatal
Description
The Prenatal Health Behaviors Scale (range: 0-96) is a 24-item scale that assesses the frequency of the use of prenatal health behaviors, including smoking, alcohol, drugs, food, vitamins, physical activity, sleep, etc in which a higher score signifies a worse outcome.
Time Frame
6-weeks postnatal
Other Pre-specified Outcome Measures:
Title
Change in Prenatal Distress at 12-weeks post-randomization
Description
The Prenatal Distress Scale (range: 0-35) is an 18-item scale that assesses the things that are worrisome or bothersome about their pregnancy in which a higher score indicates a worse outcome.
Time Frame
12-weeks post-randomization
Title
Treatment Acceptability and Preferences Scale
Description
The Treatment Acceptability and Preferences Scale (range: 0-36) is a 9-item scale that evaluates the effectiveness, acceptability, and suitability of the intervention in which a higher score indicates a better outcome.
Time Frame
4-weeks post-randomization
Title
Change in Connor-Davidson Resilience Scale at 4-weeks post-randomization
Description
The Connor-Davidson Resilience Scale (range: 0-40) is a 10-item scale that assesses the ability to cope with adversity over the last one month in which a higher score indicates a better outcome.
Time Frame
4-weeks post-randomization
Title
Expanded Adverse Childhood Experiences
Description
The Expanded Adverse Childhood Experiences survey (range: 0-21) is a 21-item questionnaire that assesses childhood adversity prior to age 18 years in which a higher score indicates a worse outcome.
Time Frame
Baseline
Title
Benevolent Childhood Experiences
Description
The Benevolent Childhood Experiences survey (range: 0-10) is a 10-item questionnaire that assesses positive childhood experiences during your first 18 years of life in which a higher score indicates a worse outcome.
Time Frame
Baseline
Title
Everyday Discrimination Scale
Description
The Everyday Discrimination Scale (range: 0-50) assesses the frequency of negative experiences as a result of one's race, ethnicity, or skin color in which a higher score indicates a worse outcome. The EDS was developed as a subjective measure to capture self-reported frequency of routine, relatively subtle discriminatory experiences in everyday social situations. Responses are typically coded on a 6-point Likert scale ranging from 'never' to 'almost everyday'.
Time Frame
Baseline
Title
Social Determinants of Health Assessment Tool
Description
The Social Determinants of Health Assessment Tool is a 10-item survey (0-10) that helps to identify health-related social needs (e.g., food, housing/utilities, transportation, and personal safety.
Time Frame
Baseline
Title
Change in Posttraumatic Stress Disorder Checklist - Civilian at 6-week postnatal
Description
Posttraumatic Stress Disorder Checklist - Civilian is a 17-item survey (range: 17-85) in which respondents indicate how much they have been bothered by each PTSD symptom over the past month using a 5-point scale ranging from 1 = not at all to 5 = extremely in which a higher score indicates a better outcome.
Time Frame
6-weeks postnatal
Title
Change in General Self-Efficacy Scale at 6-weeks postnatal
Description
The General Self-Efficacy Scale (range: 10-50) assesses confidence in one's ability to successfully perform specific tasks or behaviors in which a higher score indicates a better outcome.
Time Frame
6-weeks postnatal

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant Black women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: receiving prenatal care at Mile Square Health Center or University of Illinois Health age >/= 18 years >/= 2 adverse childhood experiences Black race English-speaking 10-24 weeks gestation able to attend four sessions owner of a smart phone and access to internet Exclusion Criteria: inability to reliably or safely participate in the study due to self-reported serious or persistent mental health disorder (e.g., schizophrenia or bipolar disorder), which could also interfere with study adherence.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen Goldstein, PhD
Phone
(312) 355-2790
Email
elleng@uic.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Dawn Koenig, PhD, RN, CNM
Email
marydh@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Goldstein, PhD, MFT
Organizational Affiliation
University of Illinois Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mile Square Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jude Fleurimont

12. IPD Sharing Statement

Learn more about this trial

Reducing Stress-Sensitive Problems Among Pregnant Black Women With Childhood Adversity

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