Community With Immigrants - a Step on the Road to Employment

NCT04725487 | Completed DMC

• 1 other identifier: UCAbsalon
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The study will investigate if a standard integration programme in combination with a social and health promoting intervention can increase health and well-being among refugee families and influence success with education and employment.

Conditions

Health Knowledge; Attitude to Health; Practice

Keywords

Refugee families; Social and health promoting intervention; Well-being; Employment; Integration

Outcome Measures

Primary Outcomes (7)

• The Warwick-Edinburgh Mental Well-Being Scale - 7 items (WEMWBS)

  WEMWBS is a validated measure of mental well-being and contains seven questions (a shortened version of the WEMWBS - 14 items). The scoring range for each item is from 1- 5, and the total score is from 7-35. The seven items have superior scaling properties to the 14 items, and mean raw scores are therefore transformed to metric scores using a standard conversion table.

  Change from baseline to 12 months and 24 months

• Mean change from baseline in self-reported health

  General health is assessed based on a question on self-reported health in the SF-12 questionnaire (a 12-Item short form health survey). SF 12 is a short version of the generic questionnaire SF 36 that measures health-related quality of life in the past four weeks. Scoring range is between 1-5 points. Mean score is calculated at baseline, 12 months and 24 months.

  Change from baseline to 12 months and 24 months

• Mean change from baseline in cortisol, nmol/L

  Cortisol measured in saliva

  Change from baseline to 24 months

• Mean change from baseline in blood sugar (HBA1C), mmol/mol

  Blood sugar measured in venous blood

  Change from baseline to 24 months

• Mean change from baseline in total cholesterol, mmol/L

  Total cholesterol measured in venous blood

  Change from baseline to 24 months

• Mean change from baseline in self-reported social relations

  Social relations are assessed based on five questions from the National Health Profile Survey (used in the Danish National Health Survey) in combination with one self-formulated question regarding contact with family members, friends, colleagues, neighbors and friends from social medias. Scoring range is between 1-5 points. Mean score is calculated at baseline, 12 months and 24 months.

  Change from baseline to 12 months and 24 months

• Change in employment status

  From unemployed to employed; from not being involved in education to being involved in education. Data from municipal registers.

  Change from baseline to 12 months and 24 months

Secondary Outcomes (7)

• Mean change from baseline in Dihydepiandrosteron-sulfate (DHEAS), µmol/L

  Change from baseline to 24 months

• Mean change from baseline in interleukin-6 (IL-6), ng/L

  Change from baseline to 24 months

• Mean change from baseline in C-reactive protein (CRP), nmol/L

  Change from baseline to 24 months

• Mean change from baseline in fibrinogen (FIBR), g/L

  Change from baseline to 24 months

• Mean change from baseline in weight

  Change from baseline to 24 months

Study Arms (2)

Standard integration program with social and health promoting intervention

EXPERIMENTAL

Participants follow the standard integration program offered by Naestved Municipality and participate in various social and health promoting activities in addition

Other: Standard integration program with social and health promoting intervention

Standard integration program

ACTIVE COMPARATOR

Participants follow the standard integration program offered by Naestved Municipality

Other: Standard integration program

Interventions

Standard integration program with social and health promoting intervention OTHER

* Basic language course, internships, courses in Labour market knowledge and Danish culture * Physical activity workshops * Community gardening (garden workshops) * Entrepreneurship course * MindSpring course * Family excursions * Danish language workshops

Standard integration program with social and health promoting intervention

Standard integration program OTHER

Standard integration program (basic language course, internships, courses in Labour market knowledge and Danish culture)

Standard integration program

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult refugees aged 18 years and above
• Young refugees aged 13 -17 years
• Must have obtained Danish asylum and live in Naestved Municipality

You may not qualify if:

• Physical and/or mental illness which prevents the individual from participating in the integration program offered by Naestved Municipality
• Illness which does not allow collection of a venous blood sample and saliva sample.

Sponsors & Collaborators

• University College Absalon: lead
• Naestved Municipality: collaborator
• Danish Refugee Council: collaborator
• Den A.P. Møllerske Støttefond: collaborator

Study Sites (1)

Nina Odgaard Nielsen

Roskilde, Region Sjælland, 4000, Denmark

Location

Study Officials

• Nina O Nielsen, Ph.d

  University College Absalon (UCAbsalon)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: January 26, 2021
• Study Start: September 1, 2018
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: May 18, 2023

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)