PovertyCRCT-HOLFNCT03102775
Comprehensive Follow-up of Low Income Families. A Cluster-randomized Study
A study testing Comprehensive follow-up program for low-income families and local family projects in people with Poverty, run by Oslo Metropolitan University at 29 sites in Norway.
Trial summary
In a cluster-randomized design, the study evaluates the effectiveness of a skill- training program for social work professionals with the aim of improving the follow-up of low income families within Norwegian labor and welfare services. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Poverty
- What is being tested?
- Comprehensive follow-up program for low-income families and local family projects
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 884 participants
- Where
- 29 sitesNorway
- Study dates
- 1 Jan 2016to 30 Dec 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Each of the 29 offices identified a target group of families prior to randomization based on the following characteristics:
- reliance on social assistance as a main source of income at least for six of the latest 12 months, or
- received social assistance in addition to other types of welfare support at least for six of the latest 12 months, and
- have up to four children under the age of 16. Based on these criteria offices identified a total of 3201 families.
Who cannot join
- Families were excluded from participation in the project if:
- they participate in other comprehensive family projects
- one or both parents/caregivers are under treatment because of heavy substance abuse and/or serious mental disorders
- the child or the children are temporary placed in child welfare institutions or living with relatives or other caregivers.
- the family is under investigation by child welfare authorities, due to suspected child neglect or that a placement to new caregivers is in process.
- Based on these criteria 320 families were excluded.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Norway29 sites
NAV Asker
Asker
NAV Bærum
Baerum
NAV Bergenhus
Bergen
NAV Fana
Bergen
NAV Bodø
Bodø
NAV Elverum
Elverum
NAV Gjøvik
Gjøvik
NAV Halden
Halden
NAV Harstad
Harstad
NAV Haugesund
Haugesund
NAV Horten
Horten
NAV Larvik
Larvik
NAV Lillehammer
Lillehammer
NAV Skjedsmo
Lillestrøm
NAV Rana
Mo i Rana
NAV Moss
Moss
NAV Alna
Oslo
NAV Bjerke
Oslo
NAV Frogner
Oslo
NAV Gamle Oslo
Oslo
NAV Gruneløkka
Oslo
NAV Nordstrand
Oslo
NAV St. Hanshaugen
Oslo
NAV Ringsaker
Ringsaker
NAV Sandefjord
Sandefjord
NAV Sandnes
Sandnes
NAV Madla
Stavanger
NAV Lerkendal
Trondheim
NAV Værnes
Værnes
About this study
Official title: A Cluster-randomised Study Evaluating the Effectiveness of a Skill-training Programme for Social Work Professionals for Improving the Follow-up of Low Income Families Within Norwegian Welfare Services
In a cluster-randomized design, the study evaluates the effectiveness of a skill- training program for social work professionals with the aim of improving the follow-up of low income families within Norwegian labor and welfare services. While the Norwegian Labor and Welfare Administration are responsible for developing and implementing the program, researchers at Oslo and Akershus University College are conducting an independent evaluation of its effectiveness. By close follow up and better coordination of existing services the model aims to improve the financial and housing situation of the family, labor market attachment among the parents and the social inclusion of children. The cluster-randomized field experiment will take place over a 40-month period, involving 29 labor and welfare offices, 58 family coordinators and, based on estimations, 650 families. The research is funded by the Norwegian Labor and Welfare Administration.
The project is financed by Labour and Welfare Administration and led by Ira Malmberg-Heimonen, Faculty of Social Sciences. Participants in the project are: Ira Malmberg-Heimonen (project leader), Anne Grete Tøge, Krisztina Gyüre, Knut Fossestøl, Marianne Rugkåsa, Berit Bergheim and Tone Liodden.
Read the detailed description
Comprehensive follow up of low-income families. A cluster-randomised study. Start 1.1 2016, Finnish 31.5 2019 Funding: Norwegian Labour and Welfare Administration
Collaboration:
Norwegian Labour and Welfare Administration
Labour and Welfare offices:
NAV Alna, NAV Asker, NAV Bergenhus, NAV Bjerke, NAV Bodø, NAV Bærum, NAV Elverum, NAV Fana, NAV Frogner, NAV Gamle Oslo, NAV Gjøvik, NAV Grunerløkka, NAV Halden, NAV Harstad, NAV Haugesund, NAV Horten, NAV Larvik, NAV Lerkendal, NAV Lillehammer, NAV Malda, NAV Moss, NAV Nordstrand, NAV Rana, NAV Ringsaker, NAV Sandefjord, NAV Sandnes, NAV Skedsmo, NAV St.Hanshaugen, NAV Værnes
International collaborators:
Professor Jukka Vuori, Finnish Institute of Occupational Health, Finland Professor Richard Price, University of Michigan, US Senior researcher Gayle Hamilton, MDRC New York, US Professor Bruce Thyer, Florida State University, US
The Norwegian Labour and Welfare Administration has developed a comprehensive model in order to improve the follow-up of low income families, and thereby decrease poverty and its consequences. By close follow up and better coordination of existing services the model aims to improve the financial and housing situation of the family, labour market attachment among the parents and the social inclusion of children.
Oslo and Akershus University College has been commissioned to evaluate the effects of the model between 2016 to 2019, with long-term follow-ups until 2021. The evaluation is conducted as a cluster-randomized controlled trial, where 29 labor and welfare offices have been randomly assigned to the experimental and control group. All 29 offices receive funding two family coordinators each in order to work with low-income families. While the experimental group offices implement the HOLF-model for the follow-up of low income families, the control group offices implement locally developed models.
Prior to randomization, a baseline questionnaire was collected from office leaders and family-coordinators, while baseline information on families is collected based on administrative data prior to randomization and questionnaire data after randomization, but prior taking part in family projects. Shorter-term effects will be measured + 12 months after baseline for families, and long-term effects will be measured based on administrative data fup to four years after baseline.
Researchers at Oslo and Akershus University College analyses the implementation processes and effects of the implementation through questionnaires, administrative data, observational data, qualitative interviews with leaders, family coordinators and families.
The project will contribute to increased knowledge about measures to improve the follow up of low income families. It will generate knowledge of whether the HOLF-model is more effective than locally developed follow-up models, knowledge important for the discussion of evidence-informed vs practice-based interventions.
The project is financed by Labor and Welfare Administration and led by Ira Malmberg-Heimonen, Faculty of Social Sciences.
Participants in the project are: Ira Malmberg-Heimonen (project leader), Anne Grete Tøge, Krisztina Gyüre, Knut Fossestøl, Marianne Rugkåsa, Berit Bergheim and Tone Liodden.
- Conditions
- Poverty
- Being tested
- Comprehensive follow-up program for low-income families, local family projects
- Keywords
- poverty, unemployment, cluster-randomized, family-project
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive follow-up program for low-income familiesOther
The main follow-up areas within the HOLF-program is to improve employment, housing, financial situation of the children. Beside manuals, family coordinators participate in five seminars with home-based tasks in between. Alo a comprehensive supervision structure is implemented that follow the train the trainer model. Coordinators ought to work directly with th families, but also with other actors important to the family, such as child-welfare and school. Coordinators should use specific tools improving the quality of the meetings, such as forms for preparation of meetings, being goal-focused and empowering.
local family projectsOther
The control group offices will develop local family projects, depending on local needs. they will also recruit and follow-up families.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive follow-up program | Experimental | 15 offices have been randomized to experimental group. Experimental group offices implement the HOLF model developed by the Labor and Welfare Administration Receives: Other: Comprehensive follow-up program for low-income families |
| Local family projects | Active comparator | 14 offices have been randomized to control group. these implement local family projects. These are developed based on local practice needs Receives: Other: local family projects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the employment situation from baseline to follow-ups
Percentage employed
Measured: T2 (+12 months after baseline), T3 (+24 months) T4 (+36 months) -T5 (+48 months)
Change in the housing situation between baseline and follow-up
Objective and subjective estimations of housing quality
Measured: T2 (+12 months after baseline)
Change in the financial situation between baseline and follow-ups
Income per month at follow-ups
Measured: T2 (+12 months after baseline), T3 (+24 months) T4 (+36 months) T5 (+48 months)
Change in children's situation from baseline to follow-up
Participation in kindergarden and other free-time activities
Measured: T2 (+12 months)
Secondary outcomes (2)
Change in professional competence between baseline and follow-up
Family coordinators professional competence. A six-item scale
Measured: T2 (+18 months)
Change in the level of working alliance between baseline and follow-up
Working Alliance Inventory Scale (short version)
Measured: T2 (+18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start1 Jan 2016
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PovertyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Cluster-randomized study. After baseline at office leader and family coordinator level as well as administrative data for families in target group, offices have been randomized to experimental and control group offices. The HOLF-model is implemeted in experimental group offices, while control group offices implement local family projects. Effects on families are analysed on the four main follow-up areas: employment, housing, financial situation and the social situation of the children.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 884 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Labour and Welfare Administration
- Responsible party
- Principal investigator, Ira Malmberg-Heimonen, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102775
- Sponsor's protocol ID
- 48510 (nsd)
- Acronym
- CRCT-HOLF
- Status last verified
- Sep 2022
- First submitted
- 7 Mar 2017
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After embargo + 5 years after finishing study (2026)
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster-randomised Study Evaluating the Effectiveness of a Skill-training Programme for Social Work Professionals for Improving the Follow-up of Low Income Families Within Norwegian Welfare Services
- ClinicalTrials.gov ID
- NCT03102775
- Acronym / sponsor ID
- CRCT-HOLF / 48510 (nsd)
- Conditions
- Poverty
- Keywords
- poverty, unemployment, cluster-randomized, family-project
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 884 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Norwegian Labour and Welfare Administration
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 6 Apr 2017 (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.
In a cluster-randomized design, the study evaluates the effectiveness of a skill- training program for social work professionals with the aim of improving the follow-up of low income families within Norwegian labor and welfare services. While the Norwegian Labor and Welfare Administration are responsible for developing and implementing the program, researchers at Oslo and Akershus University College are conducting an independent evaluation of its effectiveness. By close follow up and better coordination of existing services the model aims to improve the financial and housing situation of the family, labor market attachment among the parents and the social inclusion of children. The cluster-randomized field experiment will take place over a 40-month period, involving 29 labor and welfare offices, 58 family coordinators and, based on estimations, 650 families. The research is funded by the Norwegian Labor and Welfare Administration.
The project is financed by Labour and Welfare Administration and led by Ira Malmberg-Heimonen, Faculty of Social Sciences. Participants in the project are: Ira Malmberg-Heimonen (project leader), Anne Grete Tøge, Krisztina Gyüre, Knut Fossestøl, Marianne Rugkåsa, Berit Bergheim and Tone Liodden.
Detailed description
Comprehensive follow up of low-income families. A cluster-randomised study. Start 1.1 2016, Finnish 31.5 2019 Funding: Norwegian Labour and Welfare Administration
Collaboration:
Norwegian Labour and Welfare Administration
Labour and Welfare offices:
NAV Alna, NAV Asker, NAV Bergenhus, NAV Bjerke, NAV Bodø, NAV Bærum, NAV Elverum, NAV Fana, NAV Frogner, NAV Gamle Oslo, NAV Gjøvik, NAV Grunerløkka, NAV Halden, NAV Harstad, NAV Haugesund, NAV Horten, NAV Larvik, NAV Lerkendal, NAV Lillehammer, NAV Malda, NAV Moss, NAV Nordstrand, NAV Rana, NAV Ringsaker, NAV Sandefjord, NAV Sandnes, NAV Skedsmo, NAV St.Hanshaugen, NAV Værnes
International collaborators:
Professor Jukka Vuori, Finnish Institute of Occupational Health, Finland Professor Richard Price, University of Michigan, US Senior researcher Gayle Hamilton, MDRC New York, US Professor Bruce Thyer, Florida State University, US
The Norwegian Labour and Welfare Administration has developed a comprehensive model in order to improve the follow-up of low income families, and thereby decrease poverty and its consequences. By close follow up and better coordination of existing services the model aims to improve the financial and housing situation of the family, labour market attachment among the parents and the social inclusion of children.
Oslo and Akershus University College has been commissioned to evaluate the effects of the model between 2016 to 2019, with long-term follow-ups until 2021. The evaluation is conducted as a cluster-randomized controlled trial, where 29 labor and welfare offices have been randomly assigned to the experimental and control group. All 29 offices receive funding two family coordinators each in order to work with low-income families. While the experimental group offices implement the HOLF-model for the follow-up of low income families, the control group offices implement locally developed models.
Prior to randomization, a baseline questionnaire was collected from office leaders and family-coordinators, while baseline information on families is collected based on administrative data prior to randomization and questionnaire data after randomization, but prior taking part in family projects. Shorter-term effects will be measured + 12 months after baseline for families, and long-term effects will be measured based on administrative data fup to four years after baseline.
Researchers at Oslo and Akershus University College analyses the implementation processes and effects of the implementation through questionnaires, administrative data, observational data, qualitative interviews with leaders, family coordinators and families.
The project will contribute to increased knowledge about measures to improve the follow up of low income families. It will generate knowledge of whether the HOLF-model is more effective than locally developed follow-up models, knowledge important for the discussion of evidence-informed vs practice-based interventions.
The project is financed by Labor and Welfare Administration and led by Ira Malmberg-Heimonen, Faculty of Social Sciences.
Participants in the project are: Ira Malmberg-Heimonen (project leader), Anne Grete Tøge, Krisztina Gyüre, Knut Fossestøl, Marianne Rugkåsa, Berit Bergheim and Tone Liodden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster-randomized study. After baseline at office leader and family coordinator level as well as administrative data for families in target group, offices have been randomized to experimental and control group offices. The HOLF-model is implemeted in experimental group offices, while control group offices implement local family projects. Effects on families are analysed on the four main follow-up areas: employment, housing, financial situation and the social situation of the children.
| Arm | Type | Receives |
|---|---|---|
| Comprehensive follow-up program | Experimental | Other: Comprehensive follow-up program for low-income families15 offices have been randomized to experimental group. Experimental group offices implement the HOLF model developed by the Labor and Welfare Administration |
| Local family projects | Active comparator | Other: local family projects14 offices have been randomized to control group. these implement local family projects. These are developed based on local practice needs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Each of the 29 offices identified a target group of families prior to randomization based on the following characteristics:
- reliance on social assistance as a main source of income at least for six of the latest 12 months, or
- received social assistance in addition to other types of welfare support at least for six of the latest 12 months, and
- have up to four children under the age of 16. Based on these criteria offices identified a total of 3201 families.
Key exclusion criteria (6 listed)
- they participate in other comprehensive family projects
- one or both parents/caregivers are under treatment because of heavy substance abuse and/or serious mental disorders
- the child or the children are temporary placed in child welfare institutions or living with relatives or other caregivers.
- the family is under investigation by child welfare authorities, due to suspected child neglect or that a placement to new caregivers is in process.
- Based on these criteria 320 families were excluded.
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 |
|---|---|---|
| Comprehensive follow-up program for low-income familiesThe main follow-up areas within the HOLF-program is to improve employment, housing, financial situation of the children. Beside manuals, family coordinators participate in five seminars with home-based tasks in between. Alo a comprehensive supervision structure is implemented that follow the train the trainer model. Coordinators ought to work directly with th families, but also with other actors important to the family, such as child-welfare and school. Coordinators should use specific tools improving the quality of the meetings, such as forms for preparation of meetings, being goal-focused and empowering. | Other | Comprehensive follow-up program |
| local family projectsThe control group offices will develop local family projects, depending on local needs. they will also recruit and follow-up families. | Other | Local family projects |
Primary outcome
Changes in the employment situation from baseline to follow-ups
Time frame: T2 (+12 months after baseline), T3 (+24 months) T4 (+36 months) -T5 (+48 months)
Percentage employed
Change in the housing situation between baseline and follow-up
Time frame: T2 (+12 months after baseline)
Objective and subjective estimations of housing quality
Change in the financial situation between baseline and follow-ups
Time frame: T2 (+12 months after baseline), T3 (+24 months) T4 (+36 months) T5 (+48 months)
Income per month at follow-ups
Change in children's situation from baseline to follow-up
Time frame: T2 (+12 months)
Participation in kindergarden and other free-time activities
2 secondary outcomes
Change in professional competence between baseline and follow-up
Time frame: T2 (+18 months)
Change in the level of working alliance between baseline and follow-up
Time frame: T2 (+18 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- homepage for the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. After embargo + 5 years after finishing study (2026)
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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.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive follow-up program for low-income families and local family projects in people with Poverty, run by Oslo Metropolitan University at 29 sites in Norway.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Norway. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in the employment situation from baseline to follow-ups (time frame: T2 (+12 months after baseline), T3 (+24 months) T4 (+36 months) -T5 (+48 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2022.