A program to reduce pregnancy risks for Latina and African American women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial tests the Mastery Lifestyle Intervention (MLI), a culturally-relevant psychoeducational program designed for pregnant Hispanic and African American women at 14-20 weeks gestation. The MLI consists of six group sessions that integrate Acceptance and Commitment Therapy and Problem-Solving Therapy to improve mental health and reduce risks of preterm birth. Participants will be compared to a usual care group receiving standard prenatal care, and biological responses will be measured to assess the intervention's effectiveness. The study aims to enroll 238 women and evaluate both psychological and infant outcomes at delivery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Providing informed consent;
* Ability to read and speak English
* Pregnant at 14-20 weeks gestation with one fetus, intrauterine pregnancy, gestational dating will be reviewed before enrollment via ultrasound administered per standard of care
* Self-identification as African American or Hispanics
* Age 18 to 45 years
* Currently living in the U.S.; Women who identify as just getting along, nearly poor, or poor upon prescreen.
* Women who score 10 or greater on the Center for Epidemiological Studies Depression Scale (CES-D) OR 5 or greater on the Generalized Anxiety Disorder-7 scale (GAD-7), or 14 or \> on the Perceived Stress Scale as administered by clinical staff of the participating provider
* Willingness to adhere to the MLI regimen or usual care regimen

Exclusion Criteria:

After initial review of the electronic health record (EHR):

* Major systemic infections such as HIV, hepatitis
* \<18 years of age or \>45 years of age
* Enrollment in a prenatal program such as the Nurse Family Partnership
* Severe cognitive or psychiatric impairment per judgment of providers, that precludes cooperation with study protocol
* Inability to read English

Women who develop GDM after enrollment in the study will remain in the study. Development of hypertension or preeclampsia, pyelonephritis, or GDM will be considered an effect modifier in analysis of infant outcomes. Current antidepressant use will not be exclusionary and will also be used as an effect modifier. Further rationale for the exclusion criteria is:

* Only singleton pregnancies are included as the mechanisms of PTB are thought to differ with multiples.
* We do not exclude participants based on language (English or Spanish) spoken. We expect heterogeneity in language spoken and expect that there may be women who use both languages. Our prior study findings indicate that the risk of PTB is greatest among English-speaking and bilingual women, although we believe that all women will receive benefit from the MLI.
* Girls \<18 are excluded as the intervention is designed to improve emotional wellbeing and quality of life in mature adults; girls \<18 may not be cognitively ready for the adult intervention and may need an intervention tailored to their stage of development. Girls under 18 also have a different set of risks than women over 18 years of age.
* We will control the use of progesterone treatment statistically.
* Women who develop gestational diabetes after enrolling in the study will remain in the study.
* At enrollment or during the study, anyone who is prescribed antidepressant or anti-anxiety medications will be eligible for the study. We will make note of it and control it in analysis. If a participant is referred for individual therapy, we will obtain data from the prenatal record and control for that in the analysis

Where it's running

• Women's Specialist of PLLC
  Webster, Texas, United States Recruiting

Study contacts

• Principal investigator: Roberta J Ruiz, PhD — University of Houston
• Study coordinator: Roberta J. Ruiz, PhD
• Email: raruiz20@central.uh.edu
• Phone: 2813005265

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.