- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05511961
A Randomised Controlled Trial of Healthier Wealthier Families in Sweden (ACCESS)
December 8, 2023 updated by: Anna Sarkadi, Uppsala University
Ameliorating Child Poverty Through Connecting Economic Services With Child Health Services (ACCESS): A Randomised Controlled Trial of the Healthier Wealthier Families Model in Sweden
Healthier Wealthier Families is a way of working, where child health nurses ask parents about their financial situation and connect them to a free financial help service, if needed.
To test whether it helps families, the investigators will randomly select half of the families who want to take part to go to the service straight away and half around 3 months later.
Both groups of parents will receive a book about parenting and finances straight away.
The investigators will compare how the groups of parents answer on survey questions about meeting the costs of their children's needs, their financial knowledge, financial control, readiness to change, success on personal finance goals, mental health and financial stigma.
The investigators predict that the parents who are offered the financial help service straight away will answer more positively on the survey questions.
The investigators will ask all parents the survey questions again around 12 months later to see how they are doing.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
The Healthier Wealthier Families (HWF) model implements universal screening for economic hardship into child health services and creates a referral pathway to economic support services.
To test this, the investigators will conduct a randomised control trial.
A longitudinal follow-up with the cohort will explore whether any effects are maintained in the longer-term.
The study hypotheses are that families who have received municipal budget and debt counselling services via the HWF model will report a lower rate of child material and social deprivation.
Also, that the intervention arm will report greater financial knowledge, financial control, readiness for change, attainment of personal goals to improve one's financial situation, parental mental health and less financial stigma than the waitlist-control arm
Study Type
Interventional
Enrollment (Estimated)
142
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nina Johansson, PhD Student
- Phone Number: 0729999624
- Email: nina.johansson@pubcare.uu.se
Study Contact Backup
- Name: Georgina Warner, Assoc Prof
- Email: georgina.warner@pubcare.uu.se
Study Locations
-
-
Uppland
-
Uppsala, Uppland, Sweden, 751 23
- Recruiting
- Uppsala University
-
Contact:
- Anna Sarkadi, Prof
- Phone Number: +46(0)18-471 6572
- Email: anna.sarkadi@pubcare.uu.se
-
Principal Investigator:
- Anna Sarkadi, Prof
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Parent / caregiver of at least one child aged 0-5 years
- The family is listed at the participating child health care centre
- Parent / caregiver reports at least one risk factor for economic hardship on specified screening questions
- Parent / caregiver lives within the geographical areas served by the participating financial counselling service
- Parent / caregiver has given informed consent
Exclusion Criteria:
- Parent / caregiver does not understand the recruitment invitation.
- Parent / caregiver is already an active user of a financial counselling service.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention arm
Immediate referral to local budget and debt counselling service and a copy of 'Your child, your money', a financial guidance book for new parents
|
Budget and debt counselling will involve at least one meeting with a counsellor.
Examples of assistance the counsellors can offer include: suggestions on ways to improve a participant's financial situation; checking eligibility and helping to apply for social welfare support; helping to organise finances and develop a budget; and assistance with debt management, threatening letters or harassment by debt collectors, or imminent house eviction.
The municipal budget and debt counselling services involved in the trial will receive guidance on how to work preventatively with families, which will align with the content of the 'Your child, your money'.
The book covers topics such as planning finances, consumer rights, private insurance, family law, parental leave, pensions, saving, and budgeting.
|
Active Comparator: Waitlist-control arm
Immediately given a copy of 'Your child, your money' book, and referral to local budget and debt counselling service after a period of 3 months
|
Budget and debt counselling will involve at least one meeting with a counsellor.
Examples of assistance the counsellors can offer include: suggestions on ways to improve a participant's financial situation; checking eligibility and helping to apply for social welfare support; helping to organise finances and develop a budget; and assistance with debt management, threatening letters or harassment by debt collectors, or imminent house eviction.
The municipal budget and debt counselling services involved in the trial will receive guidance on how to work preventatively with families, which will align with the content of the 'Your child, your money'.
The book covers topics such as planning finances, consumer rights, private insurance, family law, parental leave, pensions, saving, and budgeting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child material and social deprivation (MSD)
Time Frame: 3 months after randomisation
|
The European Union (EU) measure of child MSD contains 17 items; 13 child-specific items.
Parents are asked to indicate whether or not they have the item.
If not, they are asked if it is because they cannot afford it (enforced lack) or for another reason (simple lack).
Data are collected at the household level; if one child does not have an item it is assumed that all the children in the household lack that item.
|
3 months after randomisation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Household income and sources of income
Time Frame: 3 months after randomisation
|
Overall self-reported household income on an incremental scale up to the median salary for Sweden, and fixed outgoings (e.g.
rent and bills) to calculate the net income for the household.
Also, selection of all applicable sources of income from a list, which includes all available benefits in Sweden
|
3 months after randomisation
|
Financial knowledge
Time Frame: 3 months after randomisation
|
A selection of questions covering financial knowledge and where to turn for help for better control over finances and debt management will be taken from a survey conducted by the Swedish Consumer Agency survey
|
3 months after randomisation
|
Financial control
Time Frame: 3 months after randomisation
|
A 9-item measure of financial control will be used.
Respondents will be asked to indicate the extent to which they agree or disagree with a series of nine statements using a 5-point scale, ranging from 1 (strongly disagree) to 5 (strongly agree).
|
3 months after randomisation
|
Readiness for change
Time Frame: 3 months after randomisation
|
To assess readiness for change, participants will be asked to complete a Readiness Ruler regarding changing their financial situation.
The ruler will employ a 0-10 visual analogue scale.
Scores of 1-3 represent non-readiness to change, scores of 4-6 uncertainty, scores of 7-8 represent readiness, and 9-10 represent ongoing attempts at changing.
|
3 months after randomisation
|
Personal goal
Time Frame: 3 months after randomisation
|
Participants will be asked to write a personal goal for improving their financial situation at T1. Their own words will be presented back to them at T2 and T3, and they will be asked to rate how far they have achieved their goal.
A visual analogue scale ranging from anchors "not at all" for the value 0 to "extremely" for the value 10 will be used.
|
3 months after randomisation
|
Parental mental health
Time Frame: 3 months after randomisation
|
The 12-Item General Health Questionnaire (GHQ-12).
Respondents are asked to rate the degree to which they have experienced a symptom during the last week with four response categories (e.g. less than usual, no more than usual, rather more than usual, or much more than usual).
The minimum score is 0, and the maximum is 36.
A higher score indicates a higher levels of distress.
|
3 months after randomisation
|
Perceived financial stigma
Time Frame: 3 months after randomisation
|
An 8-item measure of perceived financial stigma will be used.
Respondents are asked to indicate the extent to which they agree or disagree with a series of eight statements using a 5-point scale, ranging from 1 (definitely disagree) to 5 (definitely agree).
|
3 months after randomisation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anna Sarkadi, Prof, Uppsala University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2022
Primary Completion (Estimated)
September 30, 2024
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
August 19, 2022
First Submitted That Met QC Criteria
August 22, 2022
First Posted (Actual)
August 23, 2022
Study Record Updates
Last Update Posted (Estimated)
December 11, 2023
Last Update Submitted That Met QC Criteria
December 8, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021-01415
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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