The Role of Adverse Environment Factors, Family Functioning and Parental Psychopathology in the Response to Treatment With Methylphenidate in Children and Adolescents With Attention Deficit/Hyperactivity Disorder

NCT ID: NCT00773916

Last Updated: 2009-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2009-07-31

Brief Summary

The purpose of this study is to investigate the association of adverse environmental factors, parental psychopathology, family functioning and genetic factors and the response to methylphenidate treatment in children and adolescents with Attention Deficit/Hyperactivity Disorder.

Detailed Description

Attention Deficit/Hyperactivity Disorder (ADHD) is a chronic disorder, with a worldwide estimated prevalence of 5,29%. It is associated with a high risk of functional impairment in many aspects of the patient´s life, such as academic achievements, peers relationships and physical injuries. There are few studies assessing predictive factors of clinical response to treatment. Different patterns of family functioning, such as high family conflict and low family cohesion might be associated with a poor treatment response, possibly mediating the effects of higher severity af the disorder and/or higher prevalence of comorbidity. Parental psychopathology has been associated with a poorer prognosis and is related with family functioning. Adverse social factors have long been studied and are associated with an increased risk for general mental disease, including ADHD, as well as a poorer prognosis. Different genetic factors have been studied and associated with different aspects of the disorder and different clinical responses to treatments. There are no studies evaluating how those factors interact with each other in a Brazilian population.

Conditions

Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Methylphenidate

Dose increments according to clinical evaluation, starting with 0,3 mg/kg of weight/day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• ADHD
• Age: 5 - 18
• Primary Indication of Methylphenidate

Exclusion Criteria

• IQ < 70
• Clinical conditions that preclude use of methylphenidate

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: collaborator

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Federal University of Rio Grande do Sul

Principal Investigators

Luis A Rohde, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

ADHD Outpatient Program - Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Related Links

http://www6.ufrgs.br/prodah/

Related Info

Other Identifiers

06-208

Identifier Type: -

Identifier Source: org_study_id