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Randomized Controlled Trial With Use of Cognitive Training in Children and Adolescents With ADHD

NCT02184598 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-12-22

No results posted yet for this study

Summary

Purpose: This project assess the effectiveness of a cognitive training as an add-on intervention to drug treatment in children and adolescents diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) compared to a placebo training. The cognitive training consists of 6 computerized games that are based on principles of neuroplastic change.

ADHD: current treatment - International clinical guidelines indicate that pharmacological interventions in particular stimulants are the first-line treatment for ADHD. However, about 30% of children affected by the disorder do not respond to medication alone, exhibit partial response or can not tolerate the adverse effects. In addition there is a group of parents who do not accept the use of medication for the treatment of ADHD in their children. In recent years cognitive training has received considerable attention as a treatment to ADHD. The evidence base for cognitive training programs are still forming with few randomized placebo-controlled studies. However, this approach seems to be effective either as a treatment for ADHD - and others cognitive disorders in childhood - or as a tool to enhance cognitive ability and school performance in children and adults. No previous study has evaluated this cognitive intervention in a clinical trial with placebo-controlled intervention and as an adjunctive treatment to medication. Additionally, the investigators will assess brain changes associated with this intervention using neuroimaging (fMRI).

Conditions

  • Attention-deficit/Hyperactivity Disorder.

Interventions

BEHAVIORAL

Cognitive training

12 weeks of cognitive training; 4 sessions/week; duration 30 min

BEHAVIORAL

Placebo cognitive training

In the control group, we will use a placebo training that will consist of the same exposure time of the active training but not related to any element of cognitive training. To this end, we will set up an online platform with quiz and educational videos - being the most related to school content - without any component of executive function or working memory.

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Marcelo Schmitz, MD PhD · Hospital de Clinicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-07-31
Completion
2016-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02184598 on ClinicalTrials.gov