upREACH Perinatal Home Visitation Program

Not Applicable

Recruiting

• Conditions: Pregnancy; Postpartum

• Registration Number: NCT06133829
• Lead Sponsor: Baylor College of Medicine

Brief Summary

The purpose of this study is to assess the effectiveness of a new brief home visitation program delivered by non-nurse home visitors to 1) improve connections to community resources based on reported and assessed needs, 2) increase health self-efficacy, and 3) reduce maternal stress compared to a control group that receives standard care from an obstetric clinic.

Secondary administrative data on infant birth outcomes, health care use during the first year of life (appointment adherence), and interaction with government services (such as public assistance or child welfare) will be compared between the groups.

For the intervention group, we will secondarily also assess home visit compliance and satisfaction with the intervention.

Participants will be asked to complete questionnaires that include questions about the participant, their pregnancy, their feelings, their family, and their use of social/community services. Half of the women in this study will be randomly offered free home visitation services and the other half of women in this study will receive standard services from the clinic. The intervention group will be offered at least two free home visits with a non-nurse home visitor. During these visits, the home visitor will provide them with resources and tools to help the participant prepare for their baby. All participants will complete a second round of electronic surveys at approximately 2 months postpartum.

Intervention participant outcomes will be compared to a control group that receive standard care from an obstetric clinic.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-18
• Study Start: 2024-01-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

• Pregnant or postpartum women within 3 weeks postpartum (at enrollment)
• Receiving prenatal or postpartum care from Harris Health Clinic obstetric clinics
• Speak and read English or Spanish language.

Exclusion Criteria

• Unable to speak or read English or Spanish language
• Women that do not receive perinatal or postpartum care at Harris Health obstetric clinics
• Women that are not pregnant or greater than 4 weeks postpartum (at enrollment)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Linkages to Community Resources	through study completion, an average of 5 months	Measured by Family Resource Scale (higher score shows that resources are more adequate)
Health Self-Efficacy	through study completion, an average of 5 months	Measured by Self-Rated Abilities for Health Practices Scale (higher scores indicate higher health self-efficacy)
Maternal Stress	through study completion, an average of 5 months	Perceived Stress Scale (higher scores indicate higher levels of stress)

Secondary Outcome Measures

Name	Time	Method
Trust in Institutions	through study completion, an average of 5 months	Measured by Trust in Institutions Instrument (higher scores indicate higher trust)
Appointment Adherence	up to one year postpartum	Medical Chart Review of number of appointments attended with Obstetric and Gynecological (OB/GYN) and Pediatric Providers and Self-Report by the participant number of appointments with OB/GYN and Pediatric Appointments

Trial Locations

Locations (1)

Harris Health/Baylor College of Medicine; 🇺🇸 Houston, Texas, United States