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Cognitive Training in Children With Attention Deficit Hyperactivity Disorder (ADHD) (TDAHEC2)

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: NCT02560454
Recruitment Status : Completed
First Posted : September 25, 2015
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

ADHD is associated with cognitive deficit. Therefore, cognitive training is often proposed as an intervention for ADHD that targets cognitive deficits, with specific exercises through intensive training sessions. This intervention is based on principles of brain plasticity and cerebral functional reorganizations.

Working memory deficits constitute a key impairment in ADHD. That is why, Cogmed working memory training is the most commonly used and studied cognitive training program in clinical practice and research. It is clear from most studies that Cogmed training program increases working memory in ADHD. However, transfer of learning is not demonstrated on: other cognitive functions that are not targeted by the program, on ADHD symptoms, nor on academic achievement.

In addition to this type of intervention multi-factorial program targeting different cognitive function as Presco also exist but have been less studied.

To address these challenges, this study will follow a randomized and controlled design.

The main objective of this study is to examine the impact of cognitive training in comparison with a control waiting-list group among children with ADHD on:

  1. ADHD symptoms,
  2. cognitive functioning,
  3. attentional capacities
  4. academic achievement.

The second objective is to compare two types of cognitive training a unifactorial program Cogmed targeting working memory and a multifactorial Presco focusing on different cognitive functions affected by ADHD.

Long-term effects are examined six months after training. Participants (n=90) will be randomly assigned to the two experimental group (Cogmed or Presco) or to the control group waiting list. Participants will be evaluated three time (time 1) just before the intervention, (time 2) six weeks after the first evaluation, immediately after the intervention and (time 3) six months after the intervention.


Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder (ADHD) Behavioral: Cogmed Behavioral: Presco Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Training in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Actual Study Start Date : January 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cogmed®

Cogmed® : working memory training (unifactorial) Before beginning the program an appointment of one hour will be organized to present the program.

Participants will train at home during 25 sessions (about 30-45 minutes each) over a maximum of 5-6 weeks.

A coach will call the participant one a week to verify program adherence. The coach will verify participant results on internet before calling.

Behavioral: Cogmed

Cogmed training working memory (unifactorial). Before beginning the program an appointment of one hour will be organized to present the program.

Participants will train at home during 25 sessions (about 30-45 minutes each) over a maximum of 5-6 weeks.

A coach will call the participant one a week to verify program adherence. The coach will verify participant results on internet before calling.

Cogmed working memory training CogMed RM® (RoboMemo,Cognitive Medical Systems AB, Stockholm) version for children will be used in this program. Twelve exercises target verbal and visio-spatial working memory. Difficulty is adjusted depending on participant performance's


Experimental: Presco®

Presco® : different cognitive function are trained (multifactorial) Before beginning the program an appointment of one hour will be organized to present the program.

Participants will train at home during 25 sessions (about 30-45 minutes each) over a maximum of 5-6 weeks.

A coach will call the participant one a week to verify program adherence. The coach will verify participant results on internet before calling.

Behavioral: Presco

Presco drive of several cognitive functions (multifactorial). Before beginning the program an appointment of one hour will be organized to present the program.

Participants will train at home during 25 sessions (about 30-45 minutes each) over a maximum of 5-6 weeks.

A coach will call the participant one a week to verify program adherence. The coach will verify participant results on internet before calling.

The program PRESCO® (Program in Cognitive Stimulation and rehabilitation ) comprises 40 exercises targeting: verbal and visio spatial working memory, attention capacities, reasoning, executive functioning , language and mental imagery. Only exercises targeting verbal, visual spatial working memory, and attentional capacities altered in ADHD are used in this present study. Difficulty is adjusted depending on the participant performances.


No Intervention: Control
Control ( waiting list)



Primary Outcome Measures :
  1. The ADHD Rating Scale IV (ADHD RS) [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. ADHD Scale [ Time Frame: 6 weeks and 6 months ]
    symptoms and psychopathology associated

  2. TEA-Ch and Continuous Performance Test [ Time Frame: 6 weeks and 6 months ]
    Attentional capacities

  3. Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: 6 weeks and 6 months ]
    Cognitive functioning

  4. Wechsler Test (WIAT-II CDN-F) [ Time Frame: 6 weeks and 6 months ]
    Academic achievement



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥ 8 et ≤ 12, (2)
  • ADHD diagnostic according to DSM IV or V criteria,
  • score between 28 to 40 for The ADHD-RS,
  • IQ-score, non-verbal reasoning (WISC-III or IV) ≥80, verbal reasoning (WISC-III or IV) ≥80,
  • have internet and a computer at home,
  • if methylphenidate treatments must not be changed for six months, (7) written consent by legal guardian.

Exclusion Criteria:

  • Participant taking other medication than methylphenidate won't be included.
  • Participant suffering from another neurological disorder than ADHD won't be included

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): NCT02560454


Locations
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France
Amsellem
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Amsellem Frédérique Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02560454    
Other Study ID Numbers: K140706
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: February 2018
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cognitive Remediation
Working Memory Training
Cognitive training
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases