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

NCT02560454 | Completed

• 1 other identifier: K140706
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

Cognitive Remediation; Working Memory Training; Cognitive training

Outcome Measures

Primary Outcomes (1)

• The ADHD Rating Scale IV (ADHD RS)

  6 weeks

Secondary Outcomes (4)

• ADHD Scale

  6 weeks and 6 months

• TEA-Ch and Continuous Performance Test

  6 weeks and 6 months

• Behavior Rating Inventory of Executive Function (BRIEF)

  6 weeks and 6 months

• Wechsler Test (WIAT-II CDN-F)

  6 weeks and 6 months

Study Arms (3)

Cogmed®

EXPERIMENTAL

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

Presco®

EXPERIMENTAL

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

Control

NO INTERVENTION

Control ( waiting list)

Interventions

Cogmed BEHAVIORAL

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

Cogmed®

Presco BEHAVIORAL

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.

Presco®

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Amsellem

Paris, 75019, France

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Amsellem Frédérique

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 25, 2015
• Study Start: January 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: February 1, 2019
• Last Updated: March 13, 2019

Record last verified: 2018-02

Locations

FR (1)