Assessment of a Drama Workshop Program for Immigrant and Refugee Adolescents

March 26, 2014 updated by: Cécile Rousseau, McGill University Health Centre/Research Institute of the McGill University Health Centre
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
464

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada
        • École Antoine-de-St-Exupéry
      • Montréal, Quebec, Canada
        • École La Dauversière
      • Montréal, Quebec, Canada
        • École La Voie
      • Montréal, Quebec, Canada
        • École Lucien-Pagé
      • Montréal, Quebec, Canada
        • École Saint-Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • More severe cases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Theatre intervention
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.
Other: Theatre workshops
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.
Experimental: Group tutoring intervention
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).
Other: Group tutoring program
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.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Will be assessed by the SDQ global scores (teachers and youths reports).
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
Measured by the SDQ (teacher report).
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
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.
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cécile Rousseau, MD, McGill University Health Center, CSSS de la Montagne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIHR/IRSC-229984

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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