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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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date June 30, 2022
Est. primary completion date May 27, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Multilingual Support
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.

Locations

Country Name City State
Norway Ålesund VO Ålesund
Norway Drammen VO Drammen
Norway Lillestrøm VO Lillestrøm

Sponsors (1)

Lead Sponsor Collaborator
Oslo Metropolitan University

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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.

Outcome

Type Measure Description Time frame Safety issue
Primary Change in language skills Language tests, administered by the Norwegian Directorate for Lifelong Learning. Scale: 0-100% correct answers. Higher scores mean a better outcome. Change from Baseline language skills at 10 months
Secondary Change in Self-Efficacy in Norwegian language 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. Change from Baseline Self-Efficacy in Norwegian language at 8 months
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