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Behavioral Intervention

upREACH Home Visitation for Pregnancy (upREACH Trial)

N/A
Recruiting
Led By Cary M Cain, PhD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Speak and read English or Spanish language.
Must not have
Unable to speak or read English or Spanish language
Women that are not pregnant or greater than 4 weeks postpartum (at enrollment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one year postpartum
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new home visitation program where non-nurse visitors help pregnant women by providing resources and support during multiple home visits. The goal is to see if this program improves their connection to community resources, boosts their health confidence, and reduces stress compared to typical care.

Who is the study for?
This trial is for pregnant or postpartum women within 3 weeks after giving birth, who are patients at Harris Health Clinic obstetric clinics and can speak and read English or Spanish. Women not receiving care from these clinics, those not pregnant or over 4 weeks postpartum, or unable to understand English/Spanish cannot join.
What is being tested?
The study tests a new home visitation program called upREACH against standard clinic care. It aims to connect participants with community resources, boost health confidence, and reduce stress. Outcomes like infant health and service use will be compared between the two groups.
What are the potential side effects?
Since this is a non-medical intervention focusing on home visits by non-nurse visitors providing resources and support during pregnancy/postpartum period, traditional medical side effects are not applicable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can speak and read either English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot speak or read English or Spanish.
Select...
I am not pregnant or it has been more than 4 weeks since I gave birth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Health Self-Efficacy
Linkages to Community Resources
Maternal Stress
Secondary study objectives
Appointment Adherence
Trust in Institutions

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
Demographic and baseline measures will be obtained from the participants electronically. The participant will receive at least 1 prenatal home visit and at least 1 postpartum home visit. During the visits, the home visitor will review the screening assessments that were completed at baseline, identify health and social needs (including but not limited to referrals to substance use treatment providers, domestic violence hotline/shelters, mental health providers, applications for public assistance, and basic needs provision),work with the client to prioritize their needs, assist with applications and connections to community resources, support the participant in communicating with medical and social service providers, and provide education to help the participant advocate for their health, think ahead for after delivery (prenatal), and understand infant health and safety. At 2 months postpartum, both intervention and control groups will receive a post- survey through REDCap.
Group II: Control GroupActive Control1 Intervention
Demographic and baseline measures will be obtained from the participants electronically through REDCap surveys. The participants will receive standard care from the obstetric clinic. At approximately 2 months postpartum, both intervention and control groups will receive a post- survey through REDCap.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The Brief Home Visitation Program aims to improve maternal and neonatal outcomes by enhancing connections to community resources, increasing health self-efficacy, and reducing maternal stress. By connecting pregnant women to community resources, the program ensures they have access to essential services such as healthcare, nutrition, and social support, which are crucial for a healthy pregnancy. Increasing health self-efficacy empowers women to take control of their health and make informed decisions, leading to better adherence to prenatal care and healthier behaviors. Reducing maternal stress is vital as high stress levels can negatively impact both the mother and the fetus, potentially leading to complications such as preterm birth. These mechanisms collectively support a healthier pregnancy and improve overall maternal and neonatal health outcomes.
Improving maternal, newborn and child health outcomes through a community-based women's health education program: a cluster randomised controlled trial in western Kenya.A Novel 4D Ultrasound Parenting Intervention for Substance Using Pregnant Women in Finland: Participation in Obstetric Care, Fetal Drug Exposure, and Perinatal Outcomes in a Randomized Controlled Trial.N° 364 - La Corticothérapie Prénatale Pour Améliorer Les Issues Néonatales.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,021 Previous Clinical Trials
6,029,825 Total Patients Enrolled
Texas Department of Family Protective ServicesUNKNOWN
Cary M Cain, PhDPrincipal InvestigatorBaylor College of Medicine
~123 spots leftby Feb 2025