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

University of Illinois

Status: Completed

Conditions: Perinatal Depression; Self-Regulation, Emotion; Maternal Psychological Distress

Treatments: Other: Prenatal Education Topics; Behavioral: Trauma Informed Prenatal Intervention (TPI)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05718479

U54MD012523 (U.S. NIH Grant/Contract)

2022-1175

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Trauma Informed Prenatal Intervention (TPI)

Experimental group

Description:

The experimental arm consists of four weekly, individual (30-60 minute) sessions via Zoom with a trained behavioral health scientist and therapist facilitating motivational interviewing focused on behavior change and mental wellness skills.

Treatment:

Behavioral: Trauma Informed Prenatal Intervention (TPI)

Prenatal Education Topics

Active Comparator group

Description:

The active comparator arm consists of four weekly, individual (30-45 minute) sessions via Zoom with a research staff member delivering prenatal education topics consisting of lecture (power point slides) and video.

Treatment:

Other: Prenatal Education Topics