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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930449
• Other study ID #: 1000013779
• Status: Completed
• Phase: N/A
• First received: June 29, 2009
• Last updated: May 25, 2015
• Start date: November 2008
• Est. completion date: January 2012

Study information

• Verified date: May 2015
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Disease
• Hyperkinesis
• Learning Disorders

Intervention

Other:
• Cogmed Working Memory Training Program.
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.
• Academy of Math
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.
• Special Education/Individualized Tutoring
Students in this group will receive an additional 30 minutes daily of individualized supplemental instruction in their area of greatest academic need.

Locations

Country	Name	City	State
Canada	Ontario Provincial and Demonstration Schools	Milton	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Children's Hospital of Eastern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CANTAB Spatial Working Memory		15-20 min	No
Primary	Automated Working Memory Assessment Listening Recall		15-20 min	No
Secondary	Teacher - Strengths and Weakness of ADHD-symptoms and Normal-behavior scale (SWAN)		5 min/student	No
Secondary	Teacher - Children's Organizational Skills Scale		5 min/student	No
Secondary	Wide Range Achievement Test 4 Progress Monitoring Version: word reading, spelling, sentence comprehension, math computation		10-15 min	No