An interventional study of Welfare Benefits Advice (WBA) and Usual care in Mental Health and Financial Wellbeing, sponsored by University College, London. Not yet recruiting. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by University College, London · Not applicable, Interventional, and Health services research
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.
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:
The overall project includes four integrated work packages (WP):
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)).
University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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)
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
Appointment offered to receive financial advice from a Welfare Benefits Advisor (WBA) co-located with routine 6-8 week newborn health checks
No intervention, existing London Borough of Tower Hamlets 'service as usual'
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.
Time frame: Six months from baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Six months from baseline
No study locations are listed for this record.
Plan to share: 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).
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University College, London