LanguageNCT04935047
Pilot Trial of Multilingual Support Intervention
A study testing Multilingual Support in people with Language, run by Oslo Metropolitan University at 3 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Language
- What is being tested?
- Multilingual Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 3 sitesNorway
- Study dates
- 16 Aug 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: A Feasibility Study and a Pilot Randomised Trial of a Multilingual Support Intervention to Improve Norwegian Language Skills for Refugees
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.
Read the 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.
- Conditions
- Language
- Being tested
- Multilingual Support
- Medical subject headings
- Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multilingual SupportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (Multilingual Support) | Experimental | The treatment group will receive seven hours multilingual support weekly. Receives: Other: Multilingual Support |
| Control group | No intervention | The control group will receive the same amount of support as the experimental group, but from a person without multilingual qualifications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline language skills at 10 months
Secondary outcomes (1)
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.
Measured: Change from Baseline Self-Efficacy in Norwegian language at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start16 Aug 2021
- Primary completion27 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LanguageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Grete G Tøge, phd, Principal investigator, associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935047
- Sponsor's protocol ID
- 914633
- Status last verified
- May 2021
- First submitted
- 2 Jun 2021
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study and a Pilot Randomised Trial of a Multilingual Support Intervention to Improve Norwegian Language Skills for Refugees
- ClinicalTrials.gov ID
- NCT04935047
- Acronym / sponsor ID
- 914633
- Conditions
- Language
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (Multilingual Support) | Experimental | Other: Multilingual SupportThe treatment group will receive seven hours multilingual support weekly. |
| Control group | No intervention | –The control group will receive the same amount of support as the experimental group, but from a person without multilingual qualifications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multilingual SupportMultilingual 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. | Other | Experimental (Multilingual Support) |
Primary outcome
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.
1 secondary outcome
Change in Self-Efficacy in Norwegian language
Time frame: Change from Baseline Self-Efficacy in Norwegian language at 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- BackgroundTøge, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Grete G Tøge, phd principal investigator
associate professor
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multilingual Support in people with Language, run by Oslo Metropolitan University at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in language skills (time frame: Change from Baseline language skills at 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04935047, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.