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Stress-Reduction Education for Maternal Psychological Distress

N/A

Recruiting

Led By Ellen Goldstein, PhD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-weeks postnatal

Awards & highlights

Study Summary

This trial tests a virtual intervention to help pregnant Black women with childhood adversity enhance their mental wellness, self-awareness and self-regulation for better health outcomes.

Who is the study for?

This trial is for pregnant Black women over 18, with at least two adverse childhood experiences, between 10-24 weeks gestation. They must be receiving prenatal care at specific health centers, speak English, can attend four sessions and have a smartphone with internet access. Women with serious mental health disorders like schizophrenia or bipolar disorder are excluded.Check my eligibility

What is being tested?

The study tests a Trauma-Informed Prenatal Intervention (TPI) versus usual prenatal care plus education. TPI includes four weekly virtual motivational interviewing sessions to improve self-efficacy and mental wellness skills aimed at fostering behavior change and healthy coping in pregnant Black women with past trauma.See study design

What are the potential side effects?

Since the interventions involve educational topics and psychological support rather than medications, there are no typical drug side effects; however, discussing traumatic experiences could potentially cause emotional discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-weeks post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-weeks post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-weeks post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Edinburgh Postnatal Depression Scale at 6-weeks postnatal

Secondary outcome measures

Change in Behavioral Activation Scale at 6-weeks postnatal

Change in Five Facet Mindfulness Questionnaire at 6-weeks postnatal

Change in Generalized Anxiety Disorder Scale at 6-weeks postnatal

+3 more

Other outcome measures

Benevolent Childhood Experiences

Change in Connor-Davidson Resilience Scale at 4-weeks post-randomization

Change in General Self-Efficacy Scale at 6-weeks postnatal

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Trauma Informed Prenatal Intervention (TPI)Experimental Treatment1 Intervention

The experimental arm consists of four weekly, individual (45-60 minute) sessions via Zoom with a research staff member facilitating motivational interviewing focused on behavior change and mindfulness awareness practice.

Group II: Prenatal Education TopicsActive Control1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor

609 Previous Clinical Trials

1,559,279 Total Patients Enrolled

National Institute on Minority Health and Health Disparities (NIMHD)NIH

383 Previous Clinical Trials

1,216,329 Total Patients Enrolled

Ellen Goldstein, PhDPrincipal InvestigatorUniversity of Illinois Chicago

Media Library

Trauma Informed Prenatal Intervention (TPI) Clinical Trial Eligibility Overview. Trial Name: NCT05718479 — N/A

Childhood Trauma Research Study Groups: Trauma Informed Prenatal Intervention (TPI), Prenatal Education Topics

Childhood Trauma Clinical Trial 2023: Trauma Informed Prenatal Intervention (TPI) Highlights & Side Effects. Trial Name: NCT05718479 — N/A

Trauma Informed Prenatal Intervention (TPI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05718479 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment period for this research still open?

"The clinical trial, which was initially published on February 14th 2023, is still seeking enrollees. This information has been substantiated by the latest update to its entry on clinicaltrials.gov from May 8th of this year."

Answered by AI

What is the current quota of participants for this clinical trial?

"Affirmative. Clinicaltrials.gov attests that this clinical trial, first posted on February 14th 2023, is presently searching for participants to enrol in the study. 30 volunteers are required at a single medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Ellen Goldstein 2023. "Reducing Stress-Sensitive Problems Among Pregnant Black Women With Childhood Adversity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05718479.

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