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Comprehensive Follow-up of Low Income Families. A Cluster-randomized Study (CRCT-HOLF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03102775
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Norwegian Labour and Welfare Administration
Information provided by (Responsible Party):
Ira Malmberg-Heimonen, Oslo and Akershus University College of Applied Sciences

Brief 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. 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.

Condition or disease Intervention/treatment
Poverty Other: Comprehensive follow-up program for low-income families Other: local family projects

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention 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 (Participant)
Masking Description: While the leaders and family-coordinators are aware of whether the office has been randomized to experimental or control group offices, the families are masked for this information. they are only aware of participating in a family project, but not if experimental or control condition.
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : December 30, 2021

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
Other: Comprehensive follow-up program for low-income families
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
Other: local family projects
The control group offices will develop local family projects, depending on local needs. they will also recruit and follow-up families.

Primary Outcome Measures :
  1. 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

  2. Change in the housing situation between baseline and follow-up [ Time Frame: T2 (+12 months after baseline) ]
    Objective and subjective estimations of housing quality

  3. 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

  4. Change in children's situation from baseline to follow-up [ Time Frame: T2 (+12 months) ]
    Participation in kindergarden and other free-time activities

Secondary Outcome Measures :
  1. Change in professional competence between baseline and follow-up [ Time Frame: T2 (+18 months) ]
    Family coordinators professional competence. A six-item scale

  2. Change in the level of working alliance between baseline and follow-up [ Time Frame: T2 (+18 months) ]
    Working Alliance Inventory Scale (short version)

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03102775

Contact: Ira Malmberg-Heimonen, Pol. dr. +47 93633283
Contact: Anne Grete Tøge, PhD +47 93651644

NAV Asker Recruiting
Asker, Norway
NAV Bærum Recruiting
Baerum, Norway
NAV Bergenhus Recruiting
Bergen, Norway
NAV Fana Recruiting
Bergen, Norway
NAV Bodø Recruiting
Bodo, Norway
NAV Elverum Recruiting
Elverum, Norway
NAV Gjøvik Recruiting
Gjovik, Norway
NAV Halden Recruiting
Halden, Norway
NAV Harstad Recruiting
Harstad, Norway
NAV Haugesund Recruiting
Haugesund, Norway
NAV Horten Recruiting
Horten, Norway
NAV Larvik Recruiting
Larvik, Norway
NAV Lillehammer Recruiting
Lillehammer, Norway
NAV Skjedsmo Recruiting
Lillestrom, Norway
NAV Rana Recruiting
Mo i Rana, Norway
NAV Moss Recruiting
Moss, Norway
NAV Alna Recruiting
Oslo, Norway
NAV Bjerke Recruiting
Oslo, Norway
NAV Frogner Recruiting
Oslo, Norway
NAV Gamle Oslo Recruiting
Oslo, Norway
NAV Gruneløkka Recruiting
Oslo, Norway
NAV Nordstrand Recruiting
Oslo, Norway
NAV St. Hanshaugen Recruiting
Oslo, Norway
NAV Ringsaker Recruiting
Ringsaker, Norway
NAV Sandefjord Recruiting
Sandefjord, Norway
NAV Sandnes Recruiting
Sandnes, Norway
NAV Madla Recruiting
Stavanger, Norway
NAV Lerkendal Recruiting
Trondheim, Norway
NAV Værnes Recruiting
Vaernes, Norway
Sponsors and Collaborators
Oslo and Akershus University College of Applied Sciences
Norwegian Labour and Welfare Administration

Additional Information:
Study Data/Documents: first report (Norwegian)  This link exits the site

Responsible Party: Ira Malmberg-Heimonen, Professor, Soc Sci dr., Oslo and Akershus University College of Applied Sciences Identifier: NCT03102775     History of Changes
Other Study ID Numbers: 48510 (nsd)
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: After embargo + 5 years after finishing study (2026)

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ira Malmberg-Heimonen, Oslo and Akershus University College of Applied Sciences: