What side effects are associated with this type of intervention?

Psychological and community-based interventions during pregnancy, such as home visitation programs, group therapy, and online-delivered psychological interventions, generally have minimal physical side effects. The primary side effects are psychological and may include temporary increases in anxiety or emotional distress as participants confront and work through their issues. However, these interventions are generally well-tolerated and have been shown to significantly reduce anxiety, depression, and stress in pregnant women.

What prior FDA approvals exist?

The FDA has not specifically approved any pharmacological treatments that directly align with the goals of improving connections to community resources, increasing health self-efficacy, and reducing maternal stress during pregnancy. However, supportive care interventions, such as home visitation programs, have been recognized for their benefits in these areas. These programs often involve non-nurse home visitors providing resources, emotional support, and education to expectant mothers, which can significantly enhance maternal and infant health outcomes.

What other types of research exist?

Promising alternatives include: 1) Proactive telephone counseling programs, which have shown higher smoking cessation rates and could be adapted to provide maternal support. 2) Text messaging interventions, which offer personalized support and have been effective in smoking cessation and could be tailored for maternal health. 3) Cognitive Behavioral Therapy for Insomnia (CBT-I), which can be adapted to address maternal stress and improve sleep quality. 4) Community-based social support and education groups, which have shown positive effects on mood and self-esteem in single mothers.

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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

Select...

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one year postpartum

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.

0 / 3Eligibility criteria met

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.