Healthier Wealthier Families In East London: HWFinEL

NCT06871137 | Not Yet Recruiting

• 2 other identifiers: CCTU/2023/464NIHR158551
• Study Type: interventional
• Target: 1,153
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Difference in depression scores at 6 months

  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.

  Six months from baseline

Secondary Outcomes (4)

• 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

Study Arms (2)

Arm 1. Intervention

OTHER

Participants who are randomised to receive the intervention (Welfare Benefits Advice (WBA)) will be contacted by a UCL researcher and invited to attend a Welfare Benefits Advice appointment within 3 months of randomisation, to coincide with their new-born's 6-8 week health check.

Other: Welfare Benefits Advice (WBA)

Arm 2. Control

OTHER

Participants who are randomised to the control group will be emailed or posted a card detailing the London Borough of Tower Hamlet's existing 'service as usual' Welfare Benefits Advice services, which reproduces what is available on their website.

Other: Usual care

Interventions

Welfare Benefits Advice (WBA) OTHER

Appointment offered to receive financial advice from a Welfare Benefits Advisor (WBA) co-located with routine 6-8 week newborn health checks

Arm 1. Intervention

Usual care OTHER

No intervention, existing London Borough of Tower Hamlets 'service as usual'

Arm 2. Control

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University College, London: lead

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Claire Cameron, D Phil - Social Intervention

CONTACT

020 7612 6249; c.cameron@ucl.ac.uk

Jo Hornby, PhD

CONTACT

020 7670 5718; hfwinel@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: As above, analysing statisticians and health economists will be masked to treatment allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 11, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 11, 2025

Record last verified: 2025-03