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the Cogmed Program for Youths With ADHD (ADHDtraining)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335748
Recruitment Status : Completed
First Posted : November 8, 2017
Last Update Posted : November 8, 2017
Sponsor:
Collaborators:
Université de Montréal
Université de Sherbrooke
Paris West University Nanterre La Défense
Information provided by (Responsible Party):
Dentz Amélie, Université du Québec a Montréal

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).

Condition or disease Intervention/treatment Phase
ADHD ADHD - Combined Type Other: Cognitive training Cogmed program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double-blind evaluation Participant and assessor are blind
Primary Purpose: Treatment
Official Title: Is the Cogmed Program Effective for Youths With ADHD Under Pharmacological Treatment?
Actual Study Start Date : February 22, 2014
Actual Primary Completion Date : September 22, 2014
Actual Study Completion Date : September 22, 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. working memory [ Time Frame: 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) ]
    cognitive tests


Secondary Outcome Measures :
  1. ADHD symptoms [ Time Frame: 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) ]

    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.


  2. non-verbal reasoning [ Time Frame: 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) ]
    cognitive tests

  3. Attentional functions [ Time Frame: 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) ]
    cognitive tests

  4. Motor impulsivity [ Time Frame: 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) ]
    cognitive tests

  5. reading comprehension [ Time Frame: 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) ]
    academic achievement test

  6. Executive functionning [ Time Frame: 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 ]

    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.


  7. mathematical reasoning [ Time Frame: 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) ]
    academic achievement test



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Ages Eligible for Study:   7 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335748


Locations
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Canada, Quebec
Dentz Amélie
Montréal, Quebec, Canada, 2000
Sponsors and Collaborators
Université du Québec a Montréal
Université de Montréal
Université de Sherbrooke
Paris West University Nanterre La Défense
Investigators
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Study Director: Marie-claude Guay, Pr Université du Quebec at Montréal
Publications of Results:
Other Publications:
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Responsible Party: Dentz Amélie, Ph.d, Université du Québec a Montréal
ClinicalTrials.gov Identifier: NCT03335748    
Other Study ID Numbers: UQAM 10
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dentz Amélie, Université du Québec a Montréal:
ADHD
Combined type
Cognitive training
Intervention
Youths
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders