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Effects Of A Computerized Working Memory Training Program On Attention, Working Memory, And Academics, In Adolescents With Severe ADHD/LD

Primary Purpose

Attention Deficit Disorder With Hyperactivity, Learning Disorders

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cogmed Working Memory Training Program.
Academy of Math
Special Education/Individualized Tutoring
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring Pediatrics, Attention-Deficit Hyperactivity Disorder, Learning Disorder, Computerized Working Memory Training Program

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • fulltime enrollment at one of the three English-language speaking OPDS schools
  • confirmed diagnosis of a specific LD with or without comorbid ADHD
  • IQ > 80 (based on WISC-IV)
  • English as the primary spoken language

Exclusion Criteria:

  • uncorrected sensory impairments (vision, hearing)
  • severe comorbid mental health disorders requiring medications other than those used for ADHD or intensive treatment
  • severe impairments in oral communication, impeding intelligibility of spoken responses

Sites / Locations

  • Ontario Provincial and Demonstration Schools
  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Cogmed Working Memory Training Program

Academy of Math® program

Special Education/Individualized Tutoring

Arm Description

Outcomes

Primary Outcome Measures

CANTAB Spatial Working Memory
Automated Working Memory Assessment Listening Recall

Secondary Outcome Measures

Teacher - Strengths and Weakness of ADHD-symptoms and Normal-behavior scale (SWAN)
Teacher - Children's Organizational Skills Scale
Wide Range Achievement Test 4 Progress Monitoring Version: word reading, spelling, sentence comprehension, math computation

Full Information

First Posted
June 29, 2009
Last Updated
May 25, 2015
Sponsor
The Hospital for Sick Children
Collaborators
Children's Hospital of Eastern Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT00930449
Brief Title
Effects Of A Computerized Working Memory Training Program On Attention, Working Memory, And Academics, In Adolescents With Severe ADHD/LD
Official Title
Effects Of A Computerized Working Memory Training Program On Attention, Working Memory, And Academics, In Adolescents With Severe ADHD/LD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Children's Hospital of Eastern Ontario

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Our primary aim is to determine whether a computerized working memory (WM) training program will help students with severe learning and attention problems, in terms of improving their WM. Additional aims are to determine whether the WM training will also result in improvements in the students' concentration and school work, and how long any beneficial effects will last (i.e., whether the students will continue to show improvements once the training program has stopped).
Detailed Description
We have established a collaborative partnership between OISE, HSC, OPDS, and JVS to evaluate the effectiveness of a WM training program when conducted in a school setting. To determine whether the WM training program does improve WM, attention, behaviour, and/or academic achievement, we will compare its effects to those expected to result from two other intervention programs that focus on academic skills only: 1) a computerized software program known to improve math skills (Academy of Math®); and 2) extra, individualized tutoring in an area of academic weakness supervised by a trained and experienced staff person. We will assess WM, related cognitive abilities, ADHD symptoms, academic achievement, before and after intervention, and also at 3- and 6-month follow-up to determine whether any improvements are sustained and increased after the training has finished.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity, Learning Disorders
Keywords
Pediatrics, Attention-Deficit Hyperactivity Disorder, Learning Disorder, Computerized Working Memory Training Program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cogmed Working Memory Training Program
Arm Type
Experimental
Arm Title
Academy of Math® program
Arm Type
Active Comparator
Arm Title
Special Education/Individualized Tutoring
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Cogmed Working Memory Training Program.
Intervention Description
This program includes a set of visual-spatial and auditory-verbal WM tasks presented via the computer (see Appendix 1 for a description of these tasks). All tasks involve: a) maintenance of simultaneous mental representations of multiple stimuli; b) unique sequencing of stimulus order in each trial; and c) progressive adaptation of difficulty level as a function of individual performance. Training will require about 30 minutes per day, 5 days per week, for 5-6 weeks: participants are required to complete 90 WM trials on each training day. Training plans are individualized and are modified according to performance, but the typical plan includes 13 tasks, with 15 trials of 8 tasks each day.
Intervention Type
Other
Intervention Name(s)
Academy of Math
Intervention Description
This is an established evidence-based program designed to help at-risk learners (Grades K-12) develop mathematical proficiency by incorporating a mastery-learning approach to foster conceptual understanding, computational fluency, and strategic competency across 10 mathematical subject areas. Training is will require about 30 minutes, 5 days per week, for the same duration as the WM program (5-6 weeks), with a counselor or teacher acting as the training aide.
Intervention Type
Other
Intervention Name(s)
Special Education/Individualized Tutoring
Intervention Description
Students in this group will receive an additional 30 minutes daily of individualized supplemental instruction in their area of greatest academic need.
Primary Outcome Measure Information:
Title
CANTAB Spatial Working Memory
Time Frame
15-20 min
Title
Automated Working Memory Assessment Listening Recall
Time Frame
15-20 min
Secondary Outcome Measure Information:
Title
Teacher - Strengths and Weakness of ADHD-symptoms and Normal-behavior scale (SWAN)
Time Frame
5 min/student
Title
Teacher - Children's Organizational Skills Scale
Time Frame
5 min/student
Title
Wide Range Achievement Test 4 Progress Monitoring Version: word reading, spelling, sentence comprehension, math computation
Time Frame
10-15 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: fulltime enrollment at one of the three English-language speaking OPDS schools confirmed diagnosis of a specific LD with or without comorbid ADHD IQ > 80 (based on WISC-IV) English as the primary spoken language Exclusion Criteria: uncorrected sensory impairments (vision, hearing) severe comorbid mental health disorders requiring medications other than those used for ADHD or intensive treatment severe impairments in oral communication, impeding intelligibility of spoken responses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosemary Tannock, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ontario Provincial and Demonstration Schools
City
Milton
State/Province
Ontario
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

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Effects Of A Computerized Working Memory Training Program On Attention, Working Memory, And Academics, In Adolescents With Severe ADHD/LD

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