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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00773916
Enrollment
130
Registered
2008-10-16
Start date
2006-03-31
Completion date
2009-07-31
Last updated
2009-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit Disorder, Attention Deficit Disorders with Hyperactivity, Hyperkinetic Syndrome, Family Function, Adverse Factors, Parental Psychopathology

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.

Interventions

DRUGMethylphenidate

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

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
Hospital de Clinicas de Porto Alegre
CollaboratorOTHER
Federal University of Rio Grande do Sul
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* IQ \< 70 * Clinical conditions that preclude use of methylphenidate

Design outcomes

Primary

MeasureTime frame
SNAP -IV scores1, 2, 3 and 6 months of treatment
CGI scores1, 2, 3 and 6 months of treatment

Secondary

MeasureTime frame
Scores in CGAS1, 2, 3 and 6 months of treatment

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026