Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04935047 |
| Other study ID # |
914633 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 16, 2021 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
May 2021 |
| Source |
Oslo Metropolitan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a feasibility study and a pilot trial of a multilingual support intervention with the
aim to improve language training for Norwegian refugees by systematically using the
participants' primary language to support the learning of the new language. The study is
conducted in three Norwegian municipalities with the aim to evaluate feasibility for a
full-scale randomised controlled trial. The pilot trial will include at least 30
participants, with two thirds allocated to the treatment group and one third to the control
group. The intervention will be implemented as an add on to ordinary classroom settings. The
treatment group will receive seven hours multilingual support weekly. The control group will
receive the same amount of support, but from a person without multilingual qualifications.
The Norwegian Directorate of Integration and Diversity (IMDi) are funding the project and
have reviewed the protocol.
Description:
Design
The pilot trial is designed as an individual randomised study in three sites, conducted from
August 2021 to June 2022. Participants randomised to treatment condition will receive
language training with Multilingual Support. Participants randomised to control condition
will receive language training without Multilingual Support. The number of assistants in the
classroom will be equal in treatment and control condition, however, only the assistants in
treatment condition will master the participants' primary language and follow the guidelines
set out in Multilingual Support manual.
Participants
To be eligible for participation, persons must be at early stages of their language learning
(i.e. below A2 levels), and eight or less years of education in primary and lower secondary
school. In order to limit the number of languages provided by the Multilingual assistants,
and hence reduce the complexity of the study, we pilot the intervention and trial within the
one or two largest language groups at each site (i.e. Arabic and Kinyabwisha/Swahili in pilot
1; Coastal town; Arabic and Dari in pilot 2; Middle-town; and Arabic in pilot 3; Suburb-town.
Persons who are illiterate are excluded from the study.
Recruitment
Staff at the local Adult Vocational centre identify eligible participants for language
training with Multilingual Support from June to August 2021. When an eligible person has been
identified, the staff provides the person with information about the study. This information
will be provided in writing in Norwegian and in the person's primary language. In addition,
the information will be given orally, in eligible participants primary language, making it
possible for eligible participants to ask questions about the project. If the person agrees
to participate in the study, the staff deliver the participants email address and information
about their primary language to the researchers. Only participants that provide written
content will be included in the study.
Randomisation procedures
When receiving the participant's email address and information on primary language, the
researchers send a request to the participant, inviting him/her to respond to a baseline
survey. When responding to the baseline survey, participants are not aware of their
allocation to treatment or control condition. The survey client (Nettskjema.no) includes a
function to randomise participants. In this study we randomise participants into two groups,
with 2/3 probability of being allocated to the treatment condition. Randomisation is
conducted as independent randomisation (no stratification). After the participant has
submitted the baseline survey, the researchers can obtain information on treatment
allocation, and inform the staff at the local Adult Vocational centre about the randomisation
result, whereafter the Centre invites the participant to the Multilingual Support or the
control condition.
