Mental HealthHWFinELNCT06871137
Healthier Wealthier Families In East London: HWFinEL
A study testing Welfare Benefits Advice (WBA) in people with Mental Health and Financial Wellbeing, run by University College, London.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Mental Health, Financial Wellbeing
- What is being tested?
- Welfare Benefits Advice (WBA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,153 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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)).
- Conditions
- Mental Health, Financial Wellbeing
- Being tested
- Welfare Benefits Advice (WBA), Usual care
- Keywords
- Tower Hamlets, Welfare Benefits Advice, Financial Wellbeing, Financial Support for Parents, Money Advice for Parents, Benefits and Entitlements, Mental Health and Wellbeing
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Usual careOther
No intervention, existing London Borough of Tower Hamlets 'service as usual'
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months from baseline
Secondary outcomes (4)
Financial gain at 6 months
Difference in household financial income at 6 months' follow-up in the intervention arm compared with the control arm accounting for baseline values and for stratification values (if any). The outcomes 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 approached approaches normality.
Measured: Six months from baseline
Anxiety scores at 6 months
Difference in the General Anxiety Disorder-7 (GAD-7) scores at 6 months follow-up in the intervention arm compared with the control arm accounting for baseline values. The GAD-7 measure, is a 7-item instrument with a 4-item scale. Each item asks the individual to measure their anxiety symptoms over the past two weeks. Response options include 0 = not at all, to 3 = nearly every day. Higher scores mean a worse outcome.
Measured: Six months from baseline
Quality of Life at 6 months
Parental wellbeing: Difference in the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) scores at 6 months follow-up in the intervention arm compared with the control arm accounting for baseline values. The SWEMWBS is a 7-item scale with five response options. Each item asks the individual to measure their mental wellbeing over the past two weeks. Response options include 1 = none of the time, to 5 = all of the time. Higher scores mean a worse outcome.
Measured: Six months from baseline
Quality of life (economic evaluation) at 6 months
Difference in EuroQol-5 Dimension 5-level (EQ-5D-5L) scores at 6 months follow-up in the intervention arm compared with the control arm accounting for baseline values. It comprises of 5 dimensions of health (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with 5 levels of severity in each dimension (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). Higher scores mean a worse outcome.
Measured: Six months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871137
- Sponsor's protocol ID
- CCTU/2023/464
- Other IDs
- NIHR158551
- Acronym
- HWFinEL
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The sharing of individual participant data is not planned outside of the direct research team (or healthcare professionals who will be seeing the participant).
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06871137
- Acronym / sponsor ID
- HWFinEL / CCTU/2023/464
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,153 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1. Intervention | Other | Other: Welfare Benefits Advice (WBA)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. |
| Arm 2. Control | Other | Other: Usual careParticipants 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Only one parent will be recruited. If one parent is under the age of 16, they will not be eligible.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Welfare Benefits Advice (WBA)Appointment offered to receive financial advice from a Welfare Benefits Advisor (WBA) co-located with routine 6-8 week newborn health checks | Other | Arm 1. Intervention |
| Usual careNo intervention, existing London Borough of Tower Hamlets 'service as usual' | Other | Arm 2. Control |
Primary outcome
Difference in depression scores at 6 months
Time frame: 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.
4 secondary outcomes
Financial gain at 6 months
Time frame: Six months from baseline
Anxiety scores at 6 months
Time frame: Six months from baseline
Quality of Life at 6 months
Time frame: Six months from baseline
Quality of life (economic evaluation) at 6 months
Time frame: Six months from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Undecided. The sharing of individual participant data is not planned outside of the direct research team (or healthcare professionals who will be seeing the participant).
Related trials for Mental Health
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Welfare Benefits Advice (WBA) in people with Mental Health and Financial Wellbeing, run by University College, London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire Cameron, D Phil - Social Intervention (020 7612 6249, c.cameron@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in depression scores at 6 months (time frame: Six months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.