Clinical trial NCT06871137: Healthier Wealthier Families In East London: HWFinEL
Official title: Healthier Wealthier Families in East London (HWFinEL): Evaluating and Extending Health and Wellbeing Benefits of Universal Co-located Money Advice for Parents of Newborns
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health
Financial Wellbeing
Keywords: Tower Hamlets
Welfare Benefits Advice
Financial Wellbeing
Financial Support for Parents
Money Advice for Parents
Benefits and Entitlements
Mental Health and Wellbeing
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 1153
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HWFinEL is a randomised controlled trial with appropriately blinded statisticians and health economists during the conduct of the study. All analyses will be conducted by suitably qualified and experienced statisticians according to a detailed prespecified statistical analysis plans (SAP).

Participants will be randomised, after completion of their baseline questionnaire, in a 1:1 ratio to the intervention group or the control group and will be unblinded to their group allocation. Participants who are randomised to the intervention group will be contacted by telephone (by a UCL Researcher) and invited to attend a Welfare Benefits Advice (WBA) appointment within 3 months of randomisation.

Participants who are randomised to the control group will be emailed or posted a card to their address detailing existing 'service as usual' WBA services.

All participants will be required to complete a baseline questionnaire and a 6-month follow-up questionnaire upon study completion.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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).

The intervention will be WBA co-located with routine health appointments and delivered in Children and Families Centres (CFCs) in The London Borough (District) of Tower Hamlets. Over 98% of new babies are enrolled in the health visiting service. Co-located Welfare Benefits Advice with health appointments is an example of a Health Justice Partnership found to be an effective tool in addressing health equity.

The project will run over a period of 36 months. The target sample size is 1153 participants. The investigators will recruit over 16 months, with a 6 month internal pilot. Participants will be followed up for 6 months from the baseline time point (though could be in the trial for up to 9 months if they consent to take part in an interview (only a sub-group of participants)).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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).

Primary outcomes:
measure: Difference in depression scores at 6 months
timeFrame: Six months from baseline
Secondary outcomes:
measure: Financial gain at 6 months
timeFrame: Six months from baseline
measure: Anxiety scores at 6 months
timeFrame: Six months from baseline
measure: Quality of Life at 6 months
timeFrame: Six months from baseline
measure: Quality of life (economic evaluation) at 6 months
timeFrame: Six months from baseline
Other outcomes:
Locations:
Study officials:
References: