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Neonatal Neurodevelopmental Outcomes

Neonatal Neurodevelopmental Outcomes: Addressing Family Needs and Strengthening the Caregiver-Baby Bond

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07101757
Enrollment
200
Registered
2025-08-03
Start date
2025-09-08
Completion date
2026-08-01
Last updated
2026-04-13

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

Conditions

Anxiety, Depression, Food Insecurity, Stress

Brief summary

The main goal of this research is to help mothers with depression and anxiety to cope and bond with their baby. The next goal is to provide resources to help with household needs like food, rent, or utility assistance, health insurance. Our theory is that helping with food insecurity, household needs, and emotional health will help children and families.

Detailed description

The purpose of this study is to support families of children who are hospitalized. Participants will be asked to complete a survey regarding resources that may enhance caregiver wellbeing. These resources are intended to also support the health and developmental potential of the hospitalized child. There is a small risk of loss of confidentiality associated with participation in the research; however, the investigators have implemented multiple safeguards to protect participant information. There is no guarantee of direct benefit from participation. If a need for resources is identified, participants may be referred to hospital-based food resources or a local food bank, which could be beneficial. Additionally, many mothers of hospitalized children experience symptoms of depression, anxiety, and stress. A program is available within the hospital that includes access to a specialist and supportive resources for those experiencing such feelings. The findings from this study may inform future efforts to assist caregivers more effectively. Participation in this research is voluntary, and individuals may instead request a social work consultation to determine eligibility for available resources without enrolling in the study.

Interventions

None listed

Sponsors

Baylor College of Medicine
Lead SponsorOTHER
Episcopal Health Foundation
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* Caregivers of young infants (0-6 months of age) hospitalized at Texas Children's Hospital intensive care or acute care units. * English or Spanish speaking caregiver. * Age of caregiver ≥ 18 years old. * Caregiver willing to complete study procedures.

Exclusion criteria

* Caregivers who do not have primary custody. * Caregivers who live outside of Texas (due to lack of Houston Food Bank resources outside of Texas). * Children in CPS custody. * Caregiver is not the primary caregiver. * Previous enrollment in this study. * Neonates who are non-viable

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Intervention Implementation12 monthsAssessed by the proportion of eligible participants who enroll and complete the intervention protocol. Unit of Measure: Percentage of participants completing the intervention.
Acceptability of Intervention12 monthsMeasured using the Acceptability of Intervention Measure (AIM), a validated 4-item Likert scale assessing participant perceptions of the intervention. Unit of Measure: Mean AIM score (range: 1-5).
Caregiver Mental Health Outcomes12 monthsEvaluated using the Patient Health Questionnaire-9 (PHQ-9) for depression and the Generalized Anxiety Disorder-7 (GAD-7) scale for anxiety. Unit of Measure: Mean scores on PHQ-9 and GAD-7.
Caregiver-Infant Bonding and Nurture12 monthsAssessed using the Postpartum Bonding Questionnaire (PBQ) to evaluate caregiver-infant bonding. Unit of Measure: Mean PBQ score.
Addressing Non-Medical Drivers of Health12 monthsMeasured by the number of referrals made to food, housing, or mental health resources and the proportion of participants who accessed at least one referred service. Unit of Measure: Count of referrals and percentage of participants accessing services.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026