- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04935047
Pilot Trial of Multilingual Support Intervention
A Feasibility Study and a Pilot Randomised Trial of a Multilingual Support Intervention to Improve Norwegian Language Skills for Refugees
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Drammen, Norway
- Drammen VO
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Lillestrøm, Norway
- Lillestrøm VO
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Ålesund, Norway
- Ålesund VO
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- early stages of their language learning (i.e. below A2 levels), and
- eight or less years of education in primary and lower secondary school, and
- a major language equal to one of the Multilingual assistants.
Exclusion criteria:
None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental (Multilingual Support)
The treatment group will receive seven hours multilingual support weekly.
|
Multilingual Support is a classroom intervention, which is designed to be delivered in classes of adult learning of a new language.
The intervention involves the use of a language assistant, who is at minimum independent user (B1) in the language to be learned (in this case Norwegian), according to the language proficiency scale of the Common European Framework of Reference (CEFR) for languages, learning, teaching, assessment (Little, 2006).
The language assistant will be in the classroom for seven hours a week, collaborating with the teacher in providing language training.
In classrooms where participants have different primary languages, the language assistant(s) must cover all languages represented in the classroom.
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No Intervention: Control group
The control group will receive the same amount of support as the experimental group, but from a person without multilingual qualifications.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in language skills
Time Frame: Change from Baseline language skills at 10 months
|
Language tests, administered by the Norwegian Directorate for Lifelong Learning.
Scale: 0-100% correct answers.
Higher scores mean a better outcome.
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Change from Baseline language skills at 10 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Self-Efficacy in Norwegian language
Time Frame: Change from Baseline Self-Efficacy in Norwegian language at 8 months
|
The short Norwegian version of the English Self-Efficacy Questionnaire (Wang, Kim, Bai, & Hu, 2014).
Developed with a 7 point likert scale, but we apply a 5 point likert scale.
Higher scores mean a better outcome.
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Change from Baseline Self-Efficacy in Norwegian language at 8 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne Grete G Tøge, phd, Associate Professor
Publications and helpful links
General Publications
- Tøge, Anne Grete; Malmberg-Heimonen, Ira; Søholt, Susanne; Vilhjalmsdottir, Sigridur (2022). Protocol: Feasibility study and pilot randomised trial of a multilingual support intervention to improve Norwegian language skills for adult refugees. International Journal of Educational Research . Vol. 112.
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
- 914633
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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