NCT03335748

Brief Summary

The primary objective of this study was to examine the effects of the Cogmed training program on working memory among youths 7 to 13 years old, while controlling presence and presentation of ADHD-related comorbidity. A secondary objective was to examine the generalization of effects to ADHD symptoms, non-verbal reasoning, attentional and executive functions, motor impulsivity, reading comprehension, and mathematical reasoning. Participants were under pharmacological treatment for ADHD combined type and a comorbidity. They were randomized into an experimental group that received the Cogmed program and an active control group that received a low-intensity comparison version of the training. They were evaluated at three time points: six weeks prior to intervention onset (T1), immediately prior to onset(T2), and one week following intervention completion (T3).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

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

February 22, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

October 30, 2017

Last Update Submit

November 3, 2017

Conditions

Keywords

ADHDCombined typeCognitive trainingInterventionYouths

Outcome Measures

Primary Outcomes (1)

  • working memory

    cognitive tests

    Change is being assessed to compare the effects of the Cogmed training program and an active control group. 6 weeks prior to intervention (T1),immediately prior to intervention (T2), Just after intervention (3) and six months after follow-up (4)

Secondary Outcomes (7)

  • ADHD symptoms

    Change is being assessed to compare the effects of the Cogmed training program and an active control group. 6 weeks prior to intervention (T1),immediately prior to intervention (T2), Just after intervention (3) and six months after follow-up (4)

  • non-verbal reasoning

    Change is being assessed to compare the effects of the Cogmed training program and an active control group. 6 weeks prior to intervention (T1),immediately prior to intervention (T2), Just after intervention (3) and six months after follow-up (4)

  • Attentional functions

    Change is being assessed to compare the effects of the Cogmed training program and an active control group. 6 weeks prior to intervention (T1),immediately prior to intervention (T2), Just after intervention (3) and six months after follow-up (4)

  • Motor impulsivity

    Change is being assessed to compare the effects of the Cogmed training program and an active control group. 6 weeks prior to intervention (T1),immediately prior to intervention (T2), Just after intervention (3) and six months after follow-up (4)

  • reading comprehension

    Change is being assessed to compare the effects of the Cogmed training program and an active control group. 6 weeks prior to intervention (T1),immediately prior to intervention (T2), Just after intervention (3) and six months after follow-up (4)

  • +2 more secondary outcomes

Study Arms (2)

active control group

ACTIVE COMPARATOR

The program for the active control group is the same as for the experimental group, except that the degree of difficulty of the exercises remains low and invariable across trials, with three items needing to be recalled throughout.

Other: Cognitive training Cogmed program

the Cogmed program

EXPERIMENTAL

12 exercises proposed in the Cogmed program. Eight of these target visuospatial WM and four target verbal WM. Eight exercises are preprogrammed for each session, for a total of 90 trials (Pearsons, 2014). The degree of difficulty of the trials increases as a function of the participant's performance. For each trial, the participant receives feedback on their performance.

Other: Cognitive training Cogmed program

Interventions

Cognitive training Cogmed program

active control groupthe Cogmed program

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • (1) be 7 to 13 years old;(2) had to be diagnosed with ADHD combined type and present a comorbid learning disability, oppositional defiant disorder or Tourette syndrome;and (3) had to be medicated for ADHD,

You may not qualify if:

  • Youths were excluded from the study if diagnosed with epilepsy, an internalizing disorder (anxiety or mood disorder), an autism-spectrum disorder or mental retardation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dentz Amélie

Montreal, Quebec, 2000, Canada

Location

Related Publications (2)

  • Chacko A, Bedard AC, Marks DJ, Feirsen N, Uderman JZ, Chimiklis A, Rajwan E, Cornwell M, Anderson L, Zwilling A, Ramon M. A randomized clinical trial of Cogmed Working Memory Training in school-age children with ADHD: a replication in a diverse sample using a control condition. J Child Psychol Psychiatry. 2014 Mar;55(3):247-55. doi: 10.1111/jcpp.12146. Epub 2013 Oct 7.

    PMID: 24117656BACKGROUND
  • Klingberg T, Fernell E, Olesen PJ, Johnson M, Gustafsson P, Dahlstrom K, Gillberg CG, Forssberg H, Westerberg H. Computerized training of working memory in children with ADHD--a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry. 2005 Feb;44(2):177-86. doi: 10.1097/00004583-200502000-00010.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Marie-claude Guay, Pr

    Université du Quebec at Montréal

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double-blind evaluation Participant and assessor are blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomized into an experimental group that received the Cogmed program and an active control group that received a low-intensity comparison version of the training
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.d

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 8, 2017

Study Start

February 22, 2014

Primary Completion

September 22, 2014

Study Completion

September 22, 2015

Last Updated

November 8, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations