Learning DisabilityPhase 2/3NCT00246792
Enhancing Self-Understanding and Social Integration of Middle School Students With Learning Disabilities
A Phase 2/3 study testing Group treatment in people with Learning Disability, run by University of Toronto at 1 site in Canada.
Trial summary
Research and intervention programs for students with learning disabilities (LD) typically address child and family characteristics without examining the school context and conditions that affect adjustment. Focusing on the student with LD can highlight the child and family's deficits. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Learning Disability
- What is being tested?
- Group treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Sep 2004to Dec 2006
- Phase
- Phase 2/3
- 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 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Grades 6-8 with identified LD
- Must demonstrate need for psychosocial intervention based on results on measures
Who cannot join
- Cannot meet criteria for conduct disorder on the Teacher Report Form
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Toronto
Toronto, Ontario, M5S 1A1
Faye Mishna, PhD, (4126) 978-1385, f.mishna@utoronto.ca
Joanne Daciuk, (416) 978-5720, joanne.daciuk@utoronto.ca
About this study
Research and intervention programs for students with learning disabilities (LD) typically address child and family characteristics without examining the school context and conditions that affect adjustment. Focusing on the student with LD can highlight the child and family's deficits. An ecological theoretical framework guides this research project, a collaboration of the University of Toronto, Faculty of Social Work and Ontario Institute for Studies in Education of the University of Toronto (OISE/UT), Integra and the Toronto Catholic District School Board. This framework is based on the assumption that people are very much part of and affected by social and environmental settings. Accordingly, it is important not to see the adjustment problems of children with LD as being caused only by their LD. Instead, their academic and social problems are seen as unfolding in larger circumstances that include other children, the classroom, the school, the family and the community. These many factors act together to influence the child with LD and must be taken into account along with individual characteristics of the child.
Read the detailed description
Objectives
- Deliver an ecologically informed school-based intervention that addresses individual, social and environmental factors, to improve the adjustment of students with LD
- Examine the efficacy of the intervention
- Contribute to knowledge of the factors that influence the adjustment of students with LD
- Circulate this information to those who live and work with students with LD in order to offer understanding and direction for programs and interventions and to facilitate cross-sector collaboration
The research will utilize both quantitative and qualitative methodologies. 6 schools will be selected. 3 will receive the intervention in year 1 (2004-2005 school year), comprising 1) group treatment, 2) workshops, and 3) consultation. The other 3 schools will be controls in year 1 and receive the intervention in year 2 (2005-2006 school year).
Students in grades 6-8, identified as having LD will be offered the opportunity to participate in the project (with parental consent). This project comprises 3 components:
- School-based group treatment for students in grades 6-8 with LD and psychosocial problems. Group treatment will focus on assisting participants to understand the impact of their LD as well as on development of self-advocacy skills.
- Workshops on understanding LD for teachers, parents, and students without LD (grades 6-8).
- Conditions
- Learning Disability
- Being tested
- Group treatment
- Keywords
- School-based intervention, Learning disabilities, ecological intervention
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group treatmentBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Behaviour Checklist (Achenbach, 2001)
Youth Report Form (Achenbach, 2001)
Teacher Report Form (Achenbach, 2001)
Secondary outcomes (4)
Self-Perception Profile for Children (Harter, 1985)
The Children's Loneliness Questionnaire (Asher & Wheeler, 1985)
The Self Advocacy Interview for Students (Brunello-Prudencio, 2001)
Qualitative interviews with selected participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study startSep 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning DisabilityStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Social Sciences and Humanities Research Council of Canada, Integra LifeSciences Corporation
- Investigators
- Faye Mishna, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246792
- Sponsor's protocol ID
- 14596
- Status last verified
- Nov 2005
- First submitted
- 28 Oct 2005
- Last updated
- 17 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Self-Understanding and Social Integration of Middle School Students With Learning Disabilities
- ClinicalTrials.gov ID
- NCT00246792
- Acronym / sponsor ID
- 14596
- Conditions
- Learning Disability
- Keywords
- School-based intervention, Learning disabilities, ecological intervention
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Social Sciences and Humanities Research Council of Canada, Integra LifeSciences Corporation
- Study start
- Sep 2004
- Study completion
- Dec 2006
- First posted
- 31 Oct 2005 (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.
Research and intervention programs for students with learning disabilities (LD) typically address child and family characteristics without examining the school context and conditions that affect adjustment. Focusing on the student with LD can highlight the child and family's deficits. An ecological theoretical framework guides this research project, a collaboration of the University of Toronto, Faculty of Social Work and Ontario Institute for Studies in Education of the University of Toronto (OISE/UT), Integra and the Toronto Catholic District School Board. This framework is based on the assumption that people are very much part of and affected by social and environmental settings. Accordingly, it is important not to see the adjustment problems of children with LD as being caused only by their LD. Instead, their academic and social problems are seen as unfolding in larger circumstances that include other children, the classroom, the school, the family and the community. These many factors act together to influence the child with LD and must be taken into account along with individual characteristics of the child.
Detailed description
Objectives
- Deliver an ecologically informed school-based intervention that addresses individual, social and environmental factors, to improve the adjustment of students with LD
- Examine the efficacy of the intervention
- Contribute to knowledge of the factors that influence the adjustment of students with LD
- Circulate this information to those who live and work with students with LD in order to offer understanding and direction for programs and interventions and to facilitate cross-sector collaboration
The research will utilize both quantitative and qualitative methodologies. 6 schools will be selected. 3 will receive the intervention in year 1 (2004-2005 school year), comprising 1) group treatment, 2) workshops, and 3) consultation. The other 3 schools will be controls in year 1 and receive the intervention in year 2 (2005-2006 school year).
Students in grades 6-8, identified as having LD will be offered the opportunity to participate in the project (with parental consent). This project comprises 3 components:
- School-based group treatment for students in grades 6-8 with LD and psychosocial problems. Group treatment will focus on assisting participants to understand the impact of their LD as well as on development of self-advocacy skills.
- Workshops on understanding LD for teachers, parents, and students without LD (grades 6-8).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Grades 6-8 with identified LD
- Must demonstrate need for psychosocial intervention based on results on measures
Key exclusion criteria (1 listed)
- Cannot meet criteria for conduct disorder on the Teacher Report Form
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 treatment | Behavioural | – |
Primary outcome
Child Behaviour Checklist (Achenbach, 2001)
Youth Report Form (Achenbach, 2001)
Teacher Report Form (Achenbach, 2001)
4 secondary outcomes
Self-Perception Profile for Children (Harter, 1985)
The Children's Loneliness Questionnaire (Asher & Wheeler, 1985)
The Self Advocacy Interview for Students (Brunello-Prudencio, 2001)
Qualitative interviews with selected participants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2006.
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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.
Faye Mishna, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Group treatment in people with Learning Disability, run by University of Toronto at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 17 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faye Mishna, PhD ((416) 978-1385, f.mishn@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Behaviour Checklist (Achenbach, 2001). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2006.