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

Primary Purpose

Attention Deficit Hyperactivity Disorder (ADHD)

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cogmed
Presco
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD) focused on measuring Cognitive Remediation, Working Memory Training, Cognitive training

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Amsellem

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Cogmed®

Presco®

Control

Arm Description

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.

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.

Control ( waiting list)

Outcomes

Primary Outcome Measures

The ADHD Rating Scale IV (ADHD RS)

Secondary Outcome Measures

ADHD Scale
symptoms and psychopathology associated
TEA-Ch and Continuous Performance Test
Attentional capacities
Behavior Rating Inventory of Executive Function (BRIEF)
Cognitive functioning
Wechsler Test (WIAT-II CDN-F)
Academic achievement

Full Information

First Posted
September 17, 2015
Last Updated
March 12, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02560454
Brief Title
Cognitive Training in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Acronym
TDAHEC2
Official Title
Cognitive Training in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: ADHD symptoms, cognitive functioning, attentional capacities 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.
Detailed Description
Attention-Deficit Hyperactivity Disorder (ADHD) is a chronic developmental disorder characterized by symptoms of inattention, impulsivity and hyperactivity that do not correspond to the child's developmental level (American Psychiatric Association, 2013). For a diagnosis to be confirmed, symptoms must be present before age 12 and must be observed in at least to two domains of functioning, such as school, work, social interactions and family life (American Psychiatric Association, 2013). ADHD is one of the most common neurobehavioral disorder with a prevalence estimated at about 5-7% for school-age children (Psychiatric Association, 2013). ADHD alters family, social and academic functioning as well as one's professional life. Results from studies indicated that working memory and inhibition are often altered in ADHD in childhood and persist into adulthood. Pharmacological treatments of ADHD mostly include psychostimulants (Amphetamine and Methylphenidate) and non-stimulants (Atomoxetine, Clonidine, Guanfacine). Stimulants and no-stimulants are effective in managing ADHD symptoms. However, these treatments present some limitation. For instance, comorbid disorders reduce stimulants efficacy in ADHD. Further, long-term effects over the year of stimulant are not yet known. Stimulants may cause side effects on sleep, hunger and growth. That is why some parents are reluctant to let their children take stimulants. Currently, clinical guidelines recommend non-pharmacological interventions in conjunction with medication for the treatment of ADHD. The above-mentioned limitations to the use of medication stress the importance of developing non-pharmacological approaches. Cognitive training is one type of non-pharmacological intervention used in ADHD. This intervention consists in improving cognitive deficits through specific exercises during intensive training session. A growing number of studies examined the impact of cognitive training in ADHD. Cognitive training is based on principles of brain plasticity with the aim to train cognitive function and to improve cognitive deficits in ADHD. According to these authors, during training changes occur in neural connection associated to ADHD. This modification allows far transfers to cognitive function not targeted by the program, to ADHD symptoms and academic performances. Results from a meta-analysis indicated that 68% of 25 studies examining ADHD and cognitive training focus on working memory. These authors specify that Cogmed Working Memory Training is currently the most used and studied program. Indeed, this program is available in 25 countries and used by 150 clinical practitioners (http://www.cogmed.com). Currently, one meta-analysis including seven studies examines Cogmed Working Memory Training program effects in ADHD. Results indicated that the impact of Cogmed on cognitive functioning, ADHD symptoms and academic performance remains controversial. Cogmed is an unifactorial program targeting working memory. In addition to this type of intervention multi-factorial program targeting different cognitive function as Presco also exist but has been less studied. Objectives 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 group among children with ADHD on: ADHD symptoms, cognitive functioning, attentional capacities 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. Procedure Participants (n=90) will be randomly assigned to three groups. Cogmed® : working memory training (unifactorial) Presco® : different cognitive function are trained (multifactorial) Control ( 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. For Cogmed and Presco participants will train the same time. 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® (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder (ADHD)
Keywords
Cognitive Remediation, Working Memory Training, Cognitive training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cogmed®
Arm Type
Experimental
Arm Description
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.
Arm Title
Presco®
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control ( waiting list)
Intervention Type
Behavioral
Intervention Name(s)
Cogmed
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Presco
Intervention Description
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.
Primary Outcome Measure Information:
Title
The ADHD Rating Scale IV (ADHD RS)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
ADHD Scale
Description
symptoms and psychopathology associated
Time Frame
6 weeks and 6 months
Title
TEA-Ch and Continuous Performance Test
Description
Attentional capacities
Time Frame
6 weeks and 6 months
Title
Behavior Rating Inventory of Executive Function (BRIEF)
Description
Cognitive functioning
Time Frame
6 weeks and 6 months
Title
Wechsler Test (WIAT-II CDN-F)
Description
Academic achievement
Time Frame
6 weeks and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amsellem Frédérique
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsellem
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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