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

NCT02184598 | Unknown

• 1 other identifier: 125002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Keywords

ADHD; Cognitive training; fMRI; Cognitive function

Outcome Measures

Primary Outcomes (1)

• Change in ADHD symptomatology

  Measured by the SNAP scale filled by parents and teachers.

  Baseline; 12 weeks.

Secondary Outcomes (3)

• Change in neuropsychological function.

  Baseline; 12 weeks.

• Change in activation of front-striatal and parietal brain areas in functional magnetic resonance imaging (fMRI) during a neuropsychological test.

  Baseline; 12 weeks.

• Change in the hours and characteristic of internet use

  Baseline; 12 weeks

Study Arms (2)

Placebo cognitive training

PLACEBO COMPARATOR

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.

Behavioral: Placebo cognitive training

Cognitive training

EXPERIMENTAL

Cognitive training with 6 different games each of which gets progressively more difficult as children obtain proficiency.

Behavioral: Cognitive training

Interventions

Cognitive training BEHAVIORAL

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

Cognitive training

Placebo cognitive training BEHAVIORAL

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.

Placebo cognitive training

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female, age 6 to 13 years, ADHD diagnosis (DSM-V)
• Medicated and stabilized individuals with psychostimulant with residual symptoms of inattention - mean scores of parents and teachers \> or = 1)

You may not qualify if:

• Presence of other comorbid mental disorder that is clinically significant and requiring treatment at the time of entry in the protocol.
• intelligence quotient (IQ) \< 80

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Yale University: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Marcelo Schmitz, MD PhD

  Hospital de Clinicas de Porto Alegre

  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: April 4, 2014
• First Posted: July 9, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

BR (1)