Clinical trial NCT05718479: 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
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Psychological Distress
Perinatal Depression
Self-Regulation, Emotion
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-02-08
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 mental wellness skills (e.g., tracking, resourcing, grounding, gesturing), which can be applied to changing a behavior.
Primary purpose: TREATMENT

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 socio-emotional (e.g., mood, resilience, social support), 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=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.

Eligibility criteria: Inclusion Criteria:

* receiving prenatal care at University of Illinois Health \& Hospital System
* age \>/= 18 years
* 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.

Primary outcomes:
measure: Change in Edinburgh Postnatal Depression Scale at 2-months post-intervention
timeFrame: 6-weeks postnatal
Secondary outcomes:
measure: Change in Generalized Anxiety Disorder Scale at 2-months post-intervention
timeFrame: 6-weeks postnatal
measure: Change in Perceived Stress Scale at 2-months post-intervention
timeFrame: 6-weeks postnatal
measure: Change in Behavioral Activation Scale at 2-months post-intervention
timeFrame: 6-weeks postnatal
measure: Negative Mood Regulation Short Form Scale at 2-months post-intervention
timeFrame: 6-weeks postnatal
measure: Connor Davidson Resilience Scale at 2-months post-intervention
timeFrame: 6-weeks postpartum
measure: Prenatal Health Behaviors at 2-months post-intervention
timeFrame: 6-weeks postnatal
measure: Multidimensional Scale of Perceived Social Support at 2-months post-intervention
timeFrame: 6-weeks postpartum
Other outcomes:
measure: Prenatal Distress at 2-months post-intervention
timeFrame: 2-months post-intervention
measure: Treatment Acceptability and Preferences Scale at post-intervention
timeFrame: 4-weeks post-randomization
measure: Expanded Adverse Childhood Experiences at baseline
timeFrame: Baseline
measure: Benevolent Childhood Experiences at baseline
timeFrame: Baseline
measure: Everyday Discrimination Scale at baseline
timeFrame: Baseline
measure: Social Determinants of Health Assessment Tool at baseline
timeFrame: Baseline
Locations:
city: Chicago
country: United States
facility: University of Illinois Health & Hospital System
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Ellen Goldstein, PhD, MFT
role: PRINCIPAL_INVESTIGATOR
References: