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CompletedNCT03335748ADHDtrainingUpdated Nov 8, 2017

the Cogmed Program for Youths With ADHD

An interventional study of Cognitive training Cogmed program in ADHD and ADHD - Combined Type, sponsored by Université du Québec a Montréal. Completed at 1 site in Canada. Open to participants aged 7 Years to 13 Years. Per ClinicalTrials.gov, last updated 2017-11-08.

Sponsored by Université du Québec a Montréal · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
7 Years to 13 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • ADHD
  • ADHD - Combined Type

Keywords

  • ADHD
  • Combined type
  • Cognitive training
  • Intervention
  • Youths
03

Who can participate

Ages eligible
7 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherCognitive training Cogmed program

    Cognitive training Cogmed program

05

What researchers measure

Primary outcomes

  1. working memory

    cognitive tests

    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)

Secondary outcomes

  1. 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.

    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)

  2. non-verbal reasoning

    cognitive tests

    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)

  3. Attentional functions

    cognitive tests

    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)

  4. Motor impulsivity

    cognitive tests

    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)

  5. reading comprehension

    academic achievement test

    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)

  6. 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.

    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

  7. mathematical reasoning

    academic achievement test

    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)

06

Study locations

1 site
  • Dentz Amélie
    Montréal, Quebec 2000, Canada
07

References and documents

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. PubMed 24117656 ↗
  • 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. PubMed 15689731 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03335748
Lead sponsor
Université du Québec a Montréal
Collaborators
Université de Montréal, Université de Sherbrooke, Paris West University Nanterre La Défense
Responsible party
Dentz Amélie (Ph.d, Université du Québec a Montréal) — Principal investigator
First posted
Nov 8, 2017
Start date
Feb 22, 2014
Primary completion
Sep 22, 2014
Completion
Sep 22, 2015
Last update
Nov 8, 2017

Study contacts

Marie-claude Guay, Pr
study director · Université du Quebec at Montréal

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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