Learning DisabilitiesNCT01426451
Assessment of a Drama Workshop Program for Immigrant and Refugee Adolescents
A study testing Group tutoring program and Theatre workshops in people with Learning Disabilities, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 5 sites in Canada.
Trial summary
The purpose of this study is to determine whether a drama workshop program for immigrant and refugee youth is effective in reducing impairment in high school students presenting learning difficulties. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Learning Disabilities
- What is being tested?
- Group tutoring program and Theatre workshops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 464 participants
- Where
- 5 sitesCanada
- Study dates
- Nov 2011to Dec 2012
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All students who are assigned to special classes based on behavioural or learning problems in grades 7-10 in the participating schools will participate in the program and be included in the study if they and their parents consent to in the research.
Who cannot join
- More severe cases
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
École Antoine-de-St-Exupéry
Montreal, Quebec
École La Dauversière
Montreal, Quebec
École La Voie
Montreal, Quebec
École Lucien-Pagé
Montreal, Quebec
École Saint-Luc
Montreal, Quebec
About this study
The purpose of this study is to determine whether a drama workshop program for immigrant and refugee youth is effective in reducing impairment in high school students presenting learning difficulties.
- Conditions
- Learning Disabilities
- Being tested
- Group tutoring program, Theatre workshops
- Keywords
- Dramatherapy, Group tutoring activities, Impairment, Emotional and behavioural problems, Learning difficulties
- Medical subject headings
- Learning Disabilities, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group tutoring programOther
Academic in-class intervention that focuses on differentiated academic instruction and improved overall academic adjustment. In each classroom assigned to the tutorship intervention, two academic resource assistants will provide weekly in-class support to students for the same length of time than the drama workshop (75 minutes, once a week), with the teacher present in the classroom.
Theatre workshopsOther
The theatre expression workshops will run for 12 weeks, with one 75-minute workshop per week. They will be incorporated into the regular class timetable and will be run by the two members of the intervention team who have training in theatre and psychology, and the homeroom teacher, whose level of direct involvement will increase gradually as he or she becomes familiar with the workshops.
| Study group | Role | What they receive |
|---|---|---|
| Theatre intervention | Experimental | The theatre expression workshops will run for 12 weeks, with one 75-minute workshop per week. They will be incorporated into the regular class timetable and will be run by the two members of the intervention team who have training in theatre and psychology, and the homeroom teacher, whose level of direct involvement will increase gradually as he or she becomes familiar with the workshops. Receives: Other: Theatre workshops |
| Group tutoring intervention | Experimental | In each classroom assigned to the tutorship intervention, two academic resource assistants will provide weekly in-class support to students for the same length of time than the drama workshop (75 minutes weekly). Individualized student objectives on reading fluency and math will be implemented (one in math and one in reading per student). Receives: Other: Group tutoring program |
| No intervention | No intervention | Classes not participating neither in drama workshops nor in group tutoring activities will fill out a questionnaire as a basis for comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in impairment of emotional and behavioural symptoms reported by youth
Impairment of emotional and behavioural symptoms will be assessed by the Impact Supplement of the SDQ completed by the adolescents. The SDQ is a 25-item Likert scale assessing emotional and behavioural symptoms. This questionnaire includes an impairment measure that enquires about symptoms in terms of chronicity, distress, social impairment, and burden for others.
Measured: T0: up to 6 weeks before the intervention, T1: up to 2 weeks after the intervention, T2: between 7 and 8 months after the intervention
Secondary outcomes (4)
Change in emotional and behavioural symptoms
Will be assessed by the SDQ global scores (teachers and youths reports).
Measured: T0: up to 6 weeks before the intervention, T1: up to 2 weeks after the intervention, T2: between 7 and 8 months after the intervention
Change in impairment
Measured by the SDQ (teacher report).
Measured: T0: up to 6 weeks before the intervention, T1: up to 2 weeks after the intervention, T2: between 7 and 8 months after the intervention
Change in relations with peers
Will be assessed using the Adolescent Friendship Inventory (AFI) designed by Rubenstein et al. (1989). This 30-item instrument requires the adolescent to indicate to what degree, on a scale of 1 to 5, the feeling expressed by the statement corresponds to his or her personal feelings in relation to his or her network of peers.
Measured: T0: up to 6 weeks before the intervention, T1: up to 2 weeks after the intervention, T2: between 7 and 8 months after the intervention
Change in school performance
Will be assessed on the basis of the first and the last report cards of the school year (T0 and T1) and with the first report card of the subsequent year (T2). We will consider students' grades in mathematics and French.
Measured: T0: up to 6 weeks before the intervention, T1: up to 2 weeks after the intervention, T2: between 7 and 8 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012
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 Learning DisabilitiesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 464 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cécile Rousseau, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Cécile Rousseau, MD, Principal investigator, McGill University Health Center, CSSS de la Montagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426451
- Sponsor's protocol ID
- CIHR/IRSC-229984
- Status last verified
- Mar 2014
- First submitted
- 25 Aug 2011
- Last updated
- 27 Mar 2014
- Results posted
- No
Publications
Rousseau C, Beauregard C, Daignault K, Petrakos H, Thombs BD, Steele R, Vasiliadis HM, Hechtman L. A cluster randomized-controlled trial of a classroom-based drama workshop program to improve mental health outcomes among immigrant and refugee youth in special classes. PLoS One. 2014 Aug 15;9(8):e104704. doi: 10.1371/journal.pone.0104704. eCollection 2014.
PubMed 25127251
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Drama Workshop Program for Immigrant and Refugee Adolescents
- ClinicalTrials.gov ID
- NCT01426451
- Acronym / sponsor ID
- CIHR/IRSC-229984
- Conditions
- Learning Disabilities
- Keywords
- Dramatherapy, Group tutoring activities, Impairment, Emotional and behavioural problems, Learning difficulties
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- First posted
- 31 Aug 2011 (estimated)
- 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.
The purpose of this study is to determine whether a drama workshop program for immigrant and refugee youth is effective in reducing impairment in high school students presenting learning difficulties.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Theatre intervention | Experimental | Other: Theatre workshopsThe theatre expression workshops will run for 12 weeks, with one 75-minute workshop per week. They will be incorporated into the regular class timetable and will be run by the two members of the intervention team who have training in theatre and psychology, and the homeroom teacher, whose level of direct involvement will increase gradually as he or she becomes familiar with the workshops. |
| Group tutoring intervention | Experimental | Other: Group tutoring programIn each classroom assigned to the tutorship intervention, two academic resource assistants will provide weekly in-class support to students for the same length of time than the drama workshop (75 minutes weekly). Individualized student objectives on reading fluency and math will be implemented (one in math and one in reading per student). |
| No intervention | No intervention | –Classes not participating neither in drama workshops nor in group tutoring activities will fill out a questionnaire as a basis for comparison. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All students who are assigned to special classes based on behavioural or learning problems in grades 7-10 in the participating schools will participate in the program and be included in the study if they and their parents consent to in the research.
Key exclusion criteria (1 listed)
- More severe cases
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 |
|---|---|---|
| Group tutoring programAcademic in-class intervention that focuses on differentiated academic instruction and improved overall academic adjustment. In each classroom assigned to the tutorship intervention, two academic resource assistants will provide weekly in-class support to students for the same length of time than the drama workshop (75 minutes, once a week), with the teacher present in the classroom. | Other | Group tutoring intervention |
| Theatre workshopsThe theatre expression workshops will run for 12 weeks, with one 75-minute workshop per week. They will be incorporated into the regular class timetable and will be run by the two members of the intervention team who have training in theatre and psychology, and the homeroom teacher, whose level of direct involvement will increase gradually as he or she becomes familiar with the workshops. | Other | Theatre intervention |
Primary outcome
Change in impairment of emotional and behavioural symptoms reported by youth
Time frame: T0: up to 6 weeks before the intervention, T1: up to 2 weeks after the intervention, T2: between 7 and 8 months after the intervention
Impairment of emotional and behavioural symptoms will be assessed by the Impact Supplement of the SDQ completed by the adolescents. The SDQ is a 25-item Likert scale assessing emotional and behavioural symptoms. This questionnaire includes an impairment measure that enquires about symptoms in terms of chronicity, distress, social impairment, and burden for others.
4 secondary outcomes
Change in emotional and behavioural symptoms
Time frame: T0: up to 6 weeks before the intervention, T1: up to 2 weeks after the intervention, T2: between 7 and 8 months after the intervention
Change in impairment
Time frame: T0: up to 6 weeks before the intervention, T1: up to 2 weeks after the intervention, T2: between 7 and 8 months after the intervention
Change in relations with peers
Time frame: T0: up to 6 weeks before the intervention, T1: up to 2 weeks after the intervention, T2: between 7 and 8 months after the intervention
Change in school performance
Time frame: T0: up to 6 weeks before the intervention, T1: up to 2 weeks after the intervention, T2: between 7 and 8 months after the intervention
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 27 Mar 2014.
- Derived from this study: PubMed 25127251Rousseau C, Beauregard C, Daignault K, Petrakos H, Thombs BD, Steele R, Vasiliadis HM, Hechtman L. A cluster randomized-controlled trial of a classroom-based drama workshop program to improve mental health outcomes among immigrant and refugee youth in special classes. PLoS One. 2014 Aug 15;9(8):e104704. doi: 10.1371/journal.pone.0104704. eCollection 2014.
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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.
Cécile Rousseau, MD principal investigator
McGill University Health Center, CSSS de la Montagne
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group tutoring program and Theatre workshops in people with Learning Disabilities, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 5 sites in Canada.
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 1 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 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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 impairment of emotional and behavioural symptoms reported by youth (time frame: T0: up to 6 weeks before the intervention, T1: up to 2 weeks after the intervention, T2: between 7 and 8 months after the intervention). 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 NCT01426451, 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 27 Mar 2014.