Healthier Wealthier Families in East London (HWFinEL): Evaluating and Extending Health and Wellbeing Benefits of Universal Co-located Money Advice for Parents of Newborns
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,153
- 主要终点
- Difference in depression scores at 6 months
研究概览
简要总结
The financial condition children live in when they are young can affect their health, not only in their childhood but also throughout their lives. The cost-of-living crisis means many families are 'going without' the basics. Many people do not claim all the benefits they are entitled to, or know how to solve money problems because they find it difficult to access advice. Parents with a new-born baby are especially likely to need financial support.
Research shows that after getting money advice services linked up with routine health services, family income can improve. The investigators don't yet know if linking up money advice with routine health appointments improves parents' health and wellbeing as well as their household income. The investigators don't know whether making these services easy to access through linking them up has long term implications for children's health and wellbeing. Finally, at the moment the investigators don't know how best health and money advice services can be organised to help mothers or fathers who are in difficulty such as those who are homeless or have recently arrived in England.
The goal of this trial is to improve low-income families' living conditions and ensure that all children have the best start in life. The investigators hypothesise a co-located approach will serve as a vital step toward a more integrated approach to health and social welfare, ultimately benefitting families in need. The investigators will be comparing one group of participants who will receive welfare benefits advice from a welfare benefits advisor (WBA) that is co-located with routine 6-8 week newborn health check appointments in a Children and Families Centre (CFC). The other group will receive standard care and be given information on where they can access welfare benefits advice.
详细描述
The trial is evaluating the impact of co-located welfare benefits advice with Health Visiting appointments and the investigators will triangulate findings from the following aspects:
- A randomised controlled trial assessing the impact of money advice services on parental mental health.
- A process evaluation to assess how the intervention is implemented and how it impacts on users.
- An economic evaluation to assess the cost-benefit of the intervention.
The overall project includes four integrated work packages (WP):
- WP1 will include a process evaluation, explore service uptake and qualitative experiences of the service.
- Findings from WP1 will be used in modelling to estimate the long-term multi-sector costs and benefits of the service (WP2).
- The investigators will use qualitative methods to co-design a draft toolkit based on the experiences and participation of a marginalised group of mothers to inform service development (WP3).
- Evidence arising from WPs1-3 will be actively disseminated locally, regionally and nationally, across a range of stakeholders, and via international networks, to maximise impact (WP4).
This is a randomised controlled trial whereby participants will be randomised in a 1:1 ratio to either the intervention group (welfare benefits advice (WBA) appointment) or the control group (existing service as usual).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
As above, analysing statisticians and health economists will be masked to treatment allocation.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mothers or fathers aged 16 years or over.*
- •Mothers or fathers with a live baby/babies less than three months old who are registered with the health visitor service in LBTH, at the point of consent, who respond Yes to a screening question asking if they wish to receive advice about money.**
- •Able to provide informed consent.
- •Able and willing to complete questionnaires.
- •Please note:
- •*Only one parent will be recruited. If one parent is under the age of 16, they will not be eligible.
- •**If the participant has multiple children, at least one child must be <3 months old.
排除标准
- •Mothers or fathers with:
- •Any known safeguarding concern.
- •Maternal or paternal diagnosis of learning difficulty that affects the capacity to consent.
- •A baby/babies who have significant medical complications (e.g., inpatient on a neonatal unit).
结局指标
主要结局
Difference in depression scores at 6 months
时间窗: Six months from baseline
Difference in depression (Patient Health Questionnaire Depression Scale-8 (PHQ-8)) scores at 6 months' follow-up in the intervention arm compared with the control arm accounting for baseline values and adjusted for stratification variables (if any). The outcome will be examined to ensure that it meets the assumptions for regression analyses and transformed, if necessary, to an appropriate scale so that the resultant distribution approaches normality. The PHQ-8 is an 8-item instrument with a 4-item scale. Each item asks the individual to measure their depression symptoms over the past two weeks. Response options include 0 = not at all, to 3 = nearly every day. Higher scores mean a worse outcome.
次要结局
- Financial gain at 6 months(Six months from baseline)
- Anxiety scores at 6 months(Six months from baseline)
- Quality of Life at 6 months(Six months from baseline)
- Quality of life (economic evaluation) at 6 months(Six months from baseline)