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Active, Not Recruiting

NCT Number: NCT06133829

upREACH Perinatal Home Visitation Program

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pregnancy Postpartum

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Harris Health/Baylor College of Medicine

Houston, Texas, 77047, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

upREACH Home Visitation Program

Behavioral

upREACH is a brief perinatal home visitation program delivered by community health workers or similarly qualified personnel. The mission statement of the program is: Families are prepared to bring home their newborn to a safe, stable, and nurturing environment, and have access to tools, resources, and knowledge that promote family health and well-being. Through the program, families will receive a minimum of 2 home visits during pregnancy and/or postpartum from a home visitor (community health worker (CHW) or similarly qualified personnel). The home visitor will assess each family's strengths and needs so they may provide tailored support and brief education to promote maternal health and self-care, infant health and safety, and connection to and knowledge of resources (community orientation).

Primary outcomes

  1. Linkages to Community Resources

    Time frame: through study completion, an average of 5 months

    Measured by Family Resource Scale (higher score shows that resources are more adequate)

  2. Health Self-Efficacy

    Time frame: through study completion, an average of 5 months

    Measured by Self-Rated Abilities for Health Practices Scale (higher scores indicate higher health self-efficacy)

  3. Maternal Stress

    Time frame: through study completion, an average of 5 months

    Perceived Stress Scale (higher scores indicate higher levels of stress)

Secondary outcomes

  1. Trust in Institutions

    Time frame: through study completion, an average of 5 months

    Measured by Trust in Institutions Instrument (higher scores indicate higher trust)

  2. Appointment Adherence

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

upREACH Perinatal Home Visitation Program Randomized Controlled Trial

Acronym: upREACH

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2023
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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