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

Study Overview
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Brief Summary
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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
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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
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Drug: Methylphenidate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ADHD Age: 5 - 18 Primary Indication of Methylphenidate Exclusion Criteria: IQ < 70 Clinical conditions that preclude use of methylphenidate

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Methylphenidate|Dose increments according to clinical evaluation, starting with 0,3 mg/kg of weight/day|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNAP -IV scores |  | 1, 2, 3 and 6 months of treatment | 
| CGI scores |  | 1, 2, 3 and 6 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores in CGAS |  | 1, 2, 3 and 6 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention Deficit Disorder, Attention Deficit Disorders with Hyperactivity, Hyperkinetic Syndrome, Family Function, Adverse Factors, Parental Psychopathology