Clinical trial NCT06133829: upREACH Perinatal Home Visitation Program
Official title: upREACH Perinatal Home Visitation Program Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Postpartum
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Texas Department of Family Protective Services
First posted: 2023-11-18
Enrollment: 450
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Linkages to Community Resources
timeFrame: through study completion, an average of 5 months
measure: Health Self-Efficacy
timeFrame: through study completion, an average of 5 months
measure: Maternal Stress
timeFrame: through study completion, an average of 5 months
Secondary outcomes:
measure: Trust in Institutions
timeFrame: through study completion, an average of 5 months
measure: Appointment Adherence
timeFrame: up to one year postpartum
Other outcomes:
Locations:
city: Houston
country: United States
facility: Harris Health/Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Cary M Cain, PhD
role: PRINCIPAL_INVESTIGATOR
References: