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 socio-emotional (e.g., mood, resilience, social support), and prenatal health behaviors.
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=40) examining feasibility, acceptability, and compare initial estimates of the effects of the primary outcome of depression and secondary outcomes of psychological (e.g., stress and anxiety) and socio-emotional (e.g., mood, resilience, social support) 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). Forty adult, pregnant women receiving prenatal care at one large Federally Qualified Health Center will be enrolled between 10-24 weeks gestation. TPI participants will receive four weekly (30-60 minute) individual online sessions of motivational interviewing to facilitate behavior change and mental wellness skills to promote self-regulation. Control group participants will receive four weekly (30-60 minutes) individual online sessions of prenatal education. Patient-reported outcome measures will be interview-administered at baseline, 4- and 12-weeks post-randomization, and 6-weeks postpartum. 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 perinatal mental health among pregnant women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
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.
University of Illinois Health & Hospital System
Chicago, Illinois, United States
Change in Edinburgh Postnatal Depression Scale at 2-months post-intervention
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
Change in Generalized Anxiety Disorder Scale at 2-months post-intervention
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
Change in Perceived Stress Scale at 2-months post-intervention
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
Change in Behavioral Activation Scale at 2-months post-intervention
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
Negative Mood Regulation Short Form Scale at 2-months post-intervention
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
Connor Davidson Resilience Scale at 2-months post-intervention
The 10-item CD-RS assesses resilience over the last month. Responses are scored on a 5-point Likert scale ranging from 0 (not true at all) to 4 (true nearly all the time), with high scores representing greater ability to bounce back from adversity.
Time frame: 6-weeks postpartum
Prenatal Health Behaviors at 2-months post-intervention
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
Multidimensional Scale of Perceived Social Support at 2-months post-intervention
The 12-item MSPSS assesses social support from family, friends, and a significant other. Responses are scored on a 7-point Likert scale ranging from 1 (very strongly disagree) to 7 (very strongly agree), with high scores representing greater perceived social support.
Time frame: 6-weeks postpartum
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