Healthier Wealthier Families In East London: HWFinEL
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity College, London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Welfare Benefits Advice (WBA)
Other interventionAppointment offered to receive financial advice from a Welfare Benefits Advisor (WBA) co-located with routine 6-8 week newborn health checks
Usual care
Other interventionNo intervention, existing London Borough of Tower Hamlets 'service as usual'
Treatment groups
1,153 Participants
are divided into 2 treatment groupsGroup A: Arm 1. InterventionOther 1 intervention
Group B: Arm 2. ControlOther 1 intervention
Trial outcomes
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.
Time frame
Six months from baselineSecondary outcomes
1
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 baseline2
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 baseline3
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 baseline4
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 baselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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