Neonatal Neurodevelopmental Outcomes: Addressing Family Needs and Strengthening the Caregiver-Baby Bond
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Feasibility of Intervention Implementation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Positive Screens
- Enrollment survey
- Referral to behavior health clinician (BHC)
- Referral to emergency psychiatric services
- Referral the Houston Food Bank (HFB)
- Follow-up surveys
Negative Screens
-Enrollment survey
结局指标
主要结局
Feasibility of Intervention Implementation
时间窗: 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.
Acceptability of Intervention
时间窗: 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).
Caregiver-Infant Bonding and Nurture
时间窗: 12 months
Assessed using the Postpartum Bonding Questionnaire (PBQ) to evaluate caregiver-infant bonding. Unit of Measure: Mean PBQ score.
Caregiver Mental Health Outcomes
时间窗: 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.
Addressing Non-Medical Drivers of Health
时间窗: 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.
次要结局
未报告次要终点
研究者
Michelle Lopez
Associate Professor of Pediatrics
Baylor College of Medicine