A Randomised Controlled Trial of Healthier Wealthier Families in Sweden (ACCESS)

June 17, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
    • Uppland
      • Uppsala, Uppland, Sweden, 751 23
        • Uppsala University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Behavioral: Healthier Wealthier Families
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
Behavioral: Healthier Wealthier Families
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uppsala University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

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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