Clinical trial NCT03335748: the Cogmed Program for Youths With ADHD
Official title: Is the Cogmed Program Effective for Youths With ADHD Under Pharmacological Treatment?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
ADHD - Combined Type
Keywords: ADHD
Combined type
Cognitive training
Intervention
Youths
Lead sponsor: Université du Québec a Montréal
Sponsor class: OTHER
Collaborators: name: Université de Montréal
name: Université de Sherbrooke
name: Paris West University Nanterre La Défense
First posted: 2017-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: working memory
timeFrame: 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:
measure: ADHD symptoms
timeFrame: 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)
measure: non-verbal reasoning
timeFrame: 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)
measure: Attentional functions
timeFrame: 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)
measure: Motor impulsivity
timeFrame: 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)
measure: reading comprehension
timeFrame: 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)
measure: Executive functionning
timeFrame: 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
measure: mathematical reasoning
timeFrame: 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)
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Dentz Amélie
state: Quebec
Study officials:
affiliation: Université du Quebec at Montréal
name: Marie-claude Guay, Pr
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.