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

Health Behavior Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Childhood Trauma
• Health Behavior
• Hypersensitivity
• Maternal Psychological Distress

• NCT number: NCT05718479
• Study type: Interventional
• Source: University of Illinois at Chicago
• Contact: Ellen Goldstein, PhD
• Phone: (312) 355-2790
• Email: elleng@uic.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2023
• Completion date: December 1, 2024