the Cogmed Program for Youths With ADHD (ADHDtraining)

Is the Cogmed Program Effective for Youths With ADHD Under Pharmacological Treatment?

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).

Study Overview

• Status: Completed
• Conditions: ADHD; ADHD - Combined Type
• Intervention / Treatment: Other: Cognitive training Cogmed program

Detailed Description

Participants completed the Cogmed WM training program at home.Each training session lasted from 30 to 45 minutes and was supervised by a parent. For five consecutive weeks, participants had to complete at least five sessions per week.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, 2000
      • Dentz Amélie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (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,

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: active control group; 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; Cognitive training Cogmed program
Experimental: the Cogmed program; 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; Cognitive training Cogmed program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADHD symptoms	questionnaire Child ADHD symptoms were assessed with the Conners 3AI questionnaire (Conners, 2008). The parent version for youths 6 to 18 years old was used. Each item is rated on a Likert scale from 0 to 3 (0=never or rarely; 1=sometimes; 2=often; 3=very often). The instrument's test-retest reliability and internal consistency have been found to be satisfactory, r=.84-.93, α=.80-.93. Expected outcome-Interventions to decrease symptom of ADHD (higher values represent a worse outcome). T score Guideline 70+Very Elevated Score 65-69 Elevated Score 40-59 Average score 60-64 High average score < 40 Low score Same guidelines are used for subscales. Subscales for inattention and Hyperactivity/impulsivity are used. Symptoms indicated for each subscale are summed to get the total.	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	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)
Attentional functions	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)
Motor impulsivity	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)
reading comprehension	academic achievement test	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)
Executive functionning	Questionnaire The Behavior Rating Inventory of Executive Function (BRIEF; Gioia, Isquith, Guy, & Kenworth, 2000) was used. The parent version of the instrument comprises 86 items rated on a Likert scale from 0 to 2 (0= never or rarely; 1=sometimes; 2= often). The questionnaire's psychometric properties have been found to be adequate, with both internal consistency,α = .72-.98, and test-retest reliability,r= .82, reaching satisfactory levels. The Working Memory scale was used to measure daily WM.The Global Executive Function scale was used to assess the child's daily executive function at home and school. Expected outcome-Interventions to decrease executive dysfunction (higher values represent a worse outcome). Range : 65-100 Elevated Score 50-65 Average score < 50-0 Low score Same guidelines are used for subscales. Symptoms indicated for each subscale are summed to get the total.	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
mathematical reasoning	academic achievement test	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)

Collaborators and Investigators

• Sponsor: Université du Québec a Montréal
• Collaborators: Université de Sherbrooke; Université de Montréal; Paris West University Nanterre La Défense
• Investigators: Study Director: Marie-claude Guay, Pr, Université du Quebec at Montréal

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2014
• Primary Completion (Actual): September 22, 2014
• Study Completion (Actual): September 22, 2015

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: November 3, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 3, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: ADHD; Intervention; Cognitive training; Youths; Combined type
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: UQAM 10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No