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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reducing Stress-Sensitive Problems Among Pregnant Black Women With Childhood Adversity: A Pilot Randomized Controlled Trial of Motivational Interviewing and Mental Wellness Skills

Conditions
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Maternal Psychological Distress, Childhood Trauma, Health Behavior

Intervention / Treatment
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* Behavioral: Trauma Informed Prenatal Intervention (TPI)
* Other: Prenatal Education Topics


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trauma Informed Prenatal Intervention (TPI)<br>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. | Behavioral: Trauma Informed Prenatal Intervention (TPI)<br>* 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.<br>|
| Active Comparator: Prenatal Education Topics<br>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. | Other: Prenatal Education Topics<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6-weeks postnatal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6-weeks postnatal | 
| 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. | 6-weeks postnatal | 
| 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. | 6-weeks postnatal | 
| 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. | 6-weeks postnatal | 
| 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. | 6-weeks postpartum | 
| 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. | 6-weeks postnatal |