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Active, Not Recruiting

NCT Number: NCT07101757

Neonatal Neurodevelopmental Outcomes

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Food Insecurity Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Stress

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas Children's Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Feasibility of Intervention Implementation

    Time frame: 12 months

    Assessed by the proportion of eligible participants who enroll and complete the intervention protocol.

    Unit of Measure: Percentage of participants completing the intervention.

  2. Acceptability of Intervention

    Time frame: 12 months

    Measured 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).

  3. Caregiver Mental Health Outcomes

    Time frame: 12 months

    Evaluated 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.

  4. Caregiver-Infant Bonding and Nurture

    Time frame: 12 months

    Assessed using the Postpartum Bonding Questionnaire (PBQ) to evaluate caregiver-infant bonding.

    Unit of Measure: Mean PBQ score.

  5. Addressing Non-Medical Drivers of Health

    Time frame: 12 months

    Measured 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.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Episcopal Health Foundation

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2025
Registry last updated
Apr 13, 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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