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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

Information source: Federal University of Rio Grande do Sul
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Disorder With Hyperactivity

Intervention: Methylphenidate (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Federal University of Rio Grande do Sul

Official(s) and/or principal investigator(s):
Luis A Rohde, MD, Principal Investigator, Affiliation: Federal University of Rio Grande do Sul

Overall contact:
Rodrigo Chazan, MD, Phone: 51 2101 8094, Email: cfpaim@hcpa.ufrgs.br

Summary

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

Clinical Details

Study design: Other, Open Label, Uncontrolled, Single Group Assignment

Primary outcome:

Parental Psychopathology - SCID

Family Functioning - Family Environment Scale

Psychosocial Adversity Measurements

Secondary outcome:

ADHD symptomatology (SNAP-IV)

Scores in CGI

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.

Eligibility

Minimum age: 5 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- ADHD

- Age: 5 - 18

- Primary Indication of Methylphenidate

Exclusion Criteria:

- IQ < 70

- Clinical conditions that preclude use of methylphenidate

Locations and Contacts

Rodrigo Chazan, MD, Phone: 51 2101 8094, Email: cfpaim@hcpa.ufrgs.br

ADHD Outpatient Program - Hospital de ClĂ­nicas de Porto Alegre, Porto Alegre, Rio Grande do Sul 90035-903, Brazil; Recruiting
Rodrigo Chazan, MD, Phone: 51 2101 8094, Email: cfpaim@hcpa.ufrgs.br
Additional Information

Starting date: March 2006
Ending date: July 2009
Last updated: October 15, 2008

Page last updated: November 03, 2008

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