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upREACH Perinatal Home Visitation Program

upREACH Perinatal Home Visitation Program Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06133829
Acronym
upREACH
Enrollment
450
Registered
2023-11-18
Start date
2024-01-22
Completion date
2026-11-30
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum, Pregnancy

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.

Interventions

BEHAVIORALupREACH Home Visitation Program

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).

Sponsors

Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

The analyst will be masked to study allocation.

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Linkages to Community Resourcesthrough study completion, an average of 5 monthsMeasured by Family Resource Scale (higher score shows that resources are more adequate)
Health Self-Efficacythrough study completion, an average of 5 monthsMeasured by Self-Rated Abilities for Health Practices Scale (higher scores indicate higher health self-efficacy)
Maternal Stressthrough study completion, an average of 5 monthsPerceived Stress Scale (higher scores indicate higher levels of stress)

Secondary

MeasureTime frameDescription
Trust in Institutionsthrough study completion, an average of 5 monthsMeasured by Trust in Institutions Instrument (higher scores indicate higher trust)
Appointment Adherenceup to one year postpartumMedical 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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORCary M Cain, PhD

Baylor College of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026