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Completed

NCT Number: NCT03335748

the Cogmed Program for Youths With ADHD

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).

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Key information

Conditions

ADHD ADHD - Combined Type Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dentz Amélie

Montreal, Quebec, 2000, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive training Cogmed program

Other

Cognitive training Cogmed program

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Université du Québec a Montréal

Other

Collaborators

  • Paris West University Nanterre La Défense
  • Université de Montréal
  • Université de Sherbrooke

Registry information

Official study title

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

Acronym: ADHDtraining

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Nov 8, 2017
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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