the Cogmed Program for Youths With ADHD

ADHD Clinical Trial

— ADHDtraining  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335748
• Other study ID #: UQAM 10
• Status: Completed
• Phase: N/A
• First received: October 30, 2017
• Last updated: November 3, 2017
• Start date: February 22, 2014
• Est. completion date: September 22, 2015

Study information

• Verified date: November 2017
• Source: Universite du Quebec a Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 22, 2015
• Est. primary completion date: September 22, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• ADHD - Combined Type

Intervention

Other:
• Cognitive training Cogmed program
Cognitive training Cogmed program

Locations

Country	Name	City	State
Canada	Dentz Amélie	Montréal	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Universite du Quebec a Montreal	Paris West University Nanterre La Défense, Université de Montréal, Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Klingberg T, Fernell E, Olesen PJ, Johnson M, Gustafsson P, Dahlström 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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, a=.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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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,a = .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
Secondary	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)