- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03102775
Comprehensive Follow-up of Low Income Families. A Cluster-randomized Study (CRCT-HOLF)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Asker, Norway
- NAV Asker
-
Baerum, Norway
- NAV Bærum
-
Bergen, Norway
- NAV Bergenhus
-
Bergen, Norway
- NAV Fana
-
Bodo, Norway
- NAV Bodø
-
Elverum, Norway
- NAV Elverum
-
Gjovik, Norway
- NAV Gjøvik
-
Halden, Norway
- NAV Halden
-
Harstad, Norway
- NAV Harstad
-
Haugesund, Norway
- NAV Haugesund
-
Horten, Norway
- NAV Horten
-
Larvik, Norway
- NAV Larvik
-
Lillehammer, Norway
- NAV Lillehammer
-
Lillestrom, Norway
- NAV Skjedsmo
-
Mo i Rana, Norway
- NAV Rana
-
Moss, Norway
- NAV Moss
-
Oslo, Norway
- NAV Alna
-
Oslo, Norway
- NAV Bjerke
-
Oslo, Norway
- NAV Frogner
-
Oslo, Norway
- NAV Gamle Oslo
-
Oslo, Norway
- NAV Gruneløkka
-
Oslo, Norway
- NAV Nordstrand
-
Oslo, Norway
- NAV St. Hanshaugen
-
Ringsaker, Norway
- NAV Ringsaker
-
Sandefjord, Norway
- NAV Sandefjord
-
Sandnes, Norway
- NAV Sandnes
-
Stavanger, Norway
- NAV Madla
-
Trondheim, Norway
- NAV Lerkendal
-
Vaernes, Norway
- NAV Værnes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Comprehensive follow-up program
15 offices have been randomized to experimental group.
Experimental group offices implement the HOLF model developed by the Labor and Welfare Administration
|
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.
|
Active Comparator: Local family projects
14 offices have been randomized to control group.
these implement local family projects.
These are developed based on local practice needs
|
The control group offices will develop local family projects, depending on local needs.
they will also recruit and follow-up families.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
T2 (+12 months after baseline), T3 (+24 months) T4 (+36 months) -T5 (+48 months)
|
Change in the housing situation between baseline and follow-up
Time Frame: T2 (+12 months after baseline)
|
Objective and subjective estimations of housing quality
|
T2 (+12 months after baseline)
|
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
|
T2 (+12 months after baseline), T3 (+24 months) T4 (+36 months) T5 (+48 months)
|
Change in children's situation from baseline to follow-up
Time Frame: T2 (+12 months)
|
Participation in kindergarden and other free-time activities
|
T2 (+12 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in professional competence between baseline and follow-up
Time Frame: T2 (+18 months)
|
Family coordinators professional competence.
A six-item scale
|
T2 (+18 months)
|
Change in the level of working alliance between baseline and follow-up
Time Frame: T2 (+18 months)
|
Working Alliance Inventory Scale (short version)
|
T2 (+18 months)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in leaders competence between baseline and follow-up
Time Frame: T2 (+18 months)
|
Scale measuring office leaders competence in the follow-up of low-income families.
|
T2 (+18 months)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 48510 (nsd)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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