Material and Social Deprivation: An Enforced Lack of Necessary and Desirable Items to Lead an Adequate LifeACCESSNCT05511961
A Randomised Controlled Trial of Healthier Wealthier Families in Sweden
A study testing Healthier Wealthier Families in people with Material and Social Deprivation: An Enforced Lack of Necessary and Desirable Items to Lead an Adequate Life, run by Uppsala University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Material and Social Deprivation: An Enforced Lack of Necessary and Desirable Items to Lead an Adequate Life
- What is being tested?
- Healthier Wealthier Families
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2022to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Parent / caregiver does not understand the recruitment invitation.
- Parent / caregiver is already an active user of a financial counselling service.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Healthier Wealthier Families
- Keywords
- Child poverty, Economic services, Child health services, Healthier Wealthier Families, Sweden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthier Wealthier FamiliesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Immediate referral to local budget and debt counselling service and a copy of 'Your child, your money', a financial guidance book for new parents Receives: Behavioral: Healthier Wealthier Families |
| Waitlist-control arm | Active comparator | 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 Receives: Behavioral: Healthier Wealthier Families |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child material and social deprivation (MSD)
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.
Measured: 3 months after randomisation
Secondary outcomes (7)
Household income and sources of income
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
Measured: 3 months after randomisation
Financial knowledge
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
Measured: 3 months after randomisation
Financial control
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).
Measured: 3 months after randomisation
Readiness for change
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.
Measured: 3 months after randomisation
Personal goal
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.
Measured: 3 months after randomisation
Parental mental health
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.
Measured: 3 months after randomisation
Perceived financial stigma
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).
Measured: 3 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Sep 2022
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Why it stopped: Full trial considered unfeasible after internal pilot. Internal pilot to be published. Record will be updated when publication available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Material and Social Deprivation: An Enforced Lack of Necessary and Desirable Items to Lead an Adequate LifeStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm randomised waitlist-control superiority trial (1:1 allocation ratio) will be conducted to evaluate the effectiveness of the HWF model in improving the financial situation of families who have self-reported economic difficulties. The intervention arm will be referred to budget and debt counselling immediately after randomisation and the waitlist-control arm around 3 months later. Both arms will be offered a financial guidance book at randomisation. Randomised controlled trial (RCT) assessments will take place at two points: pre-intervention (T1) and post-intervention (T2; around 3 months after randomisation). Longitudinal cohort assessment (both arms) will take place around 12 months after randomisation.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Sarkadi, Uppsala University
- Investigators
- Anna Sarkadi, Prof, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511961
- Sponsor's protocol ID
- 2021-01415
- Acronym
- ACCESS
- Status last verified
- Apr 2025
- First submitted
- 19 Aug 2022
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johansson N, Sarkadi A, Isaksson D, Warner G. Feasibility of a randomised controlled trial of Healthier Wealthier Families in Sweden: results from the Ameliorating Child poverty through Connecting Economic Services with child health Services (ACCESS) pilot study. BMC Health Serv Res. 2025 Dec 1;25(1):1561. doi: 10.1186/s12913-025-13753-y.
PubMed 41327350Johansson N, Sarkadi A, Feldman I, Price AMH, Goldfeld S, Salonen T, Wijk K, Isaksson D, Kolic E, Stenquist S, Elg M, Lonn E, Wennelin J, Lindstrom L, Medina M, Aberg S, Viklund J, Warner G. Ameliorating Child poverty through Connecting Economic Services with child health Services (ACCESS): study protocol for a randomised controlled trial of the healthier wealthier families model in Sweden. BMC Public Health. 2022 Nov 25;22(1):2181. doi: 10.1186/s12889-022-14424-x.
PubMed 36434580
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ameliorating Child Poverty Through Connecting Economic Services With Child Health Services (ACCESS): A Randomised Controlled Trial of the Healthier Wealthier Families Model in Sweden
- ClinicalTrials.gov ID
- NCT05511961
- Acronym / sponsor ID
- ACCESS / 2021-01415
- Keywords
- Child poverty, Economic services, Child health services, Healthier Wealthier Families, Sweden
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Full trial considered unfeasible after internal pilot. Internal pilot to be published. Record will be updated when publication available.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 23 Aug 2022 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two-arm randomised waitlist-control superiority trial (1:1 allocation ratio) will be conducted to evaluate the effectiveness of the HWF model in improving the financial situation of families who have self-reported economic difficulties. The intervention arm will be referred to budget and debt counselling immediately after randomisation and the waitlist-control arm around 3 months later. Both arms will be offered a financial guidance book at randomisation. Randomised controlled trial (RCT) assessments will take place at two points: pre-intervention (T1) and post-intervention (T2; around 3 months after randomisation). Longitudinal cohort assessment (both arms) will take place around 12 months after randomisation.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Healthier Wealthier FamiliesImmediate referral to local budget and debt counselling service and a copy of 'Your child, your money', a financial guidance book for new parents |
| Waitlist-control arm | Active comparator | Behavioral: Healthier Wealthier FamiliesImmediately given a copy of 'Your child, your money' book, and referral to local budget and debt counselling service after a period of 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Parent / caregiver does not understand the recruitment invitation.
- Parent / caregiver is already an active user of a financial counselling service.
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 |
|---|---|---|
| Healthier Wealthier FamiliesBudget 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. | Behavioural | Intervention arm, Waitlist-control arm |
Primary outcome
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.
7 secondary outcomes
Household income and sources of income
Time frame: 3 months after randomisation
Financial knowledge
Time frame: 3 months after randomisation
Financial control
Time frame: 3 months after randomisation
Readiness for change
Time frame: 3 months after randomisation
Personal goal
Time frame: 3 months after randomisation
Parental mental health
Time frame: 3 months after randomisation
Perceived financial stigma
Time frame: 3 months after randomisation
Results and safety
The study was stopped early (reason given: Full trial considered unfeasible after internal pilot. Internal pilot to be published. Record will be updated when publication available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Derived from this study: PubMed 41327350Johansson N, Sarkadi A, Isaksson D, Warner G. Feasibility of a randomised controlled trial of Healthier Wealthier Families in Sweden: results from the Ameliorating Child poverty through Connecting Economic Services with child health Services (ACCESS) pilot study. BMC Health Serv Res. 2025 Dec 1;25(1):1561. doi: 10.1186/s12913-025-13753-y.
- Derived from this study: PubMed 36434580Johansson N, Sarkadi A, Feldman I, Price AMH, Goldfeld S, Salonen T, Wijk K, Isaksson D, Kolic E, Stenquist S, Elg M, Lonn E, Wennelin J, Lindstrom L, Medina M, Aberg S, Viklund J, Warner G. Ameliorating Child poverty through Connecting Economic Services with child health Services (ACCESS): study protocol for a randomised controlled trial of the healthier wealthier families model in Sweden. BMC Public Health. 2022 Nov 25;22(1):2181. doi: 10.1186/s12889-022-14424-x.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Anna Sarkadi, Prof principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthier Wealthier Families in people with Material and Social Deprivation: An Enforced Lack of Necessary and Desirable Items to Lead an Adequate Life, run by Uppsala University at 1 site in Sweden.
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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Full trial considered unfeasible after internal pilot. Internal pilot to be published. Record will be updated when publication available.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child material and social deprivation (MSD) (time frame: 3 months after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05511961, which also lists 2 linked publications.
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 22 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.