NCT00930449

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

2.2 years

First QC Date

June 29, 2009

Last Update Submit

May 25, 2015

Conditions

Keywords

PediatricsAttention-Deficit Hyperactivity DisorderLearning DisorderComputerized Working Memory Training Program

Outcome Measures

Primary Outcomes (2)

  • CANTAB Spatial Working Memory

    15-20 min

  • Automated Working Memory Assessment Listening Recall

    15-20 min

Secondary Outcomes (3)

  • Teacher - Strengths and Weakness of ADHD-symptoms and Normal-behavior scale (SWAN)

    5 min/student

  • Teacher - Children's Organizational Skills Scale

    5 min/student

  • Wide Range Achievement Test 4 Progress Monitoring Version: word reading, spelling, sentence comprehension, math computation

    10-15 min

Study Arms (3)

Cogmed Working Memory Training Program

EXPERIMENTAL
Other: Cogmed Working Memory Training Program.

Academy of Math® program

ACTIVE COMPARATOR
Other: Academy of Math

Special Education/Individualized Tutoring

ACTIVE COMPARATOR
Other: Special Education/Individualized Tutoring

Interventions

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.

Cogmed Working Memory Training Program

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.

Academy of Math® program

Students in this group will receive an additional 30 minutes daily of individualized supplemental instruction in their area of greatest academic need.

Special Education/Individualized Tutoring

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ontario Provincial and Demonstration Schools

Milton, Ontario, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityLearning Disabilities

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rosemary Tannock, MD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

June 29, 2009

First Posted

June 30, 2009

Study Start

November 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2012

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations