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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00246792
Other study ID # 14596
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received October 28, 2005
Last updated February 16, 2006
Start date September 2004
Est. completion date December 2006

Study information

Verified date November 2005
Source University of Toronto
Contact Faye Mishna, PhD
Phone (416) 978-1385
Email f.mishn@utoronto.ca
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical 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. 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.


Description:

Objectives

1. Deliver an ecologically informed school-based intervention that addresses individual, social and environmental factors, to improve the adjustment of students with LD

2. Examine the efficacy of the intervention

3. Contribute to knowledge of the factors that influence the adjustment of students with LD

4. 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:

1. 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.

2. Workshops on understanding LD for teachers, parents, and students without LD (grades 6-8).


Recruitment information / eligibility

Status Recruiting
Enrollment 0
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 10 Years to 15 Years
Eligibility Inclusion Criteria:

- Grades 6-8 with identified LD

- Must demonstrate need for psychosocial intervention based on results on measures

Exclusion Criteria:

- Cannot meet criteria for conduct disorder on the Teacher Report Form

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Group treatment


Locations

Country Name City State
Canada University of Toronto Toronto Ontario

Sponsors (3)

Lead Sponsor Collaborator
University of Toronto Integra, Social Sciences and Humanities Research Council of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Child Behaviour Checklist (Achenbach, 2001)
Primary Youth Report Form (Achenbach, 2001)
Primary Teacher Report Form (Achenbach, 2001)
Secondary Self-Perception Profile for Children (Harter, 1985)
Secondary The Children’s Loneliness Questionnaire (Asher & Wheeler, 1985)
Secondary The Self Advocacy Interview for Students (Brunello-Prudencio, 2001)
Secondary Qualitative interviews with selected participants
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