Overview

This trial is active, not recruiting.

Condition adult adhd
Treatment concerta
Phase phase 4
Sponsor University of Maryland
Collaborator McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Start date December 2004
End date December 2006
Trial size 40 participants
Trial identifier NCT00318981, IIS-2003-023

Summary

This study involves a 7 week dose-response trial of Concerta™ methylphenidate for mothers of children with ADHD who have ADHD themselves. The aim of this study is to assess the efficacy of Concerta™ in improving adult ADHD symptoms and impairments (primary outcome), as well as observed and reported parenting (secondary outcome). The researchers hypothesize that Concerta™ will significantly decrease mothers ADHD symptoms and impairment, as well as improve observed and reported parenting

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
Adult ADHD symptoms (Conners Adult ADHD Rating Scale)
time frame:
Impairment ratings (CGI)
time frame:
Side Effects (Pittsburgh Side Effect Scale)
time frame:

Secondary Outcomes

Measure
Parenting measures (Parenting Stress Index, Alabama Parenting Questionnaire, O'Leary Parenting Scale, Observed Parent Child Interaction)
time frame:

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: Mother: - Have ADHD or problems paying attention and concentration themselves - Have a child 6-12 years old with ADHD or possible ADHD - Be the child’s biological mother Exclusion Criteria: - Any CURRENT Axis I disorder (including major depression, psychosis, and substance use disorders) but with the exception of minor depressive or anxiety disorders - Use of Anti-depressant medication - Mothers with severe tics or Tourette’s syndrome, a history of seizures or abnormal EEGs, high blood pressure, or narrowing or blockage of the GI tract - Any women pregnant or brest-feeding

Additional Information

Official title Efficacy of Concerta in Treating ADHD in Mothers of Children With ADHD
Principal investigator Andre M Chronis, PhD
Description There is evidence to suggest that ADHD persists in approximately 50-65% of individuals diagnosed with the disorder during childhood. Due to the familial nature and presumed genetic etiology of this disorder, parents with ADHD are more likely to have children also diagnosed with ADHD. Accordingly, higher rates of adult ADHD have been found in parents of children with ADHD. Recent research has determined that among children with ADHD, there is a 23 times greater rate of ADHD in mothers and a 4 times greater rate of ADHD in fathers relative to parents of children without the disorder. Research has also suggested that ADHD symptoms that persist into adulthood are impairing in many areas of an individual’s life, including their family functioning and work functioning. Spouses of ADHD adults report that their partners’ difficulties with communication, task completion, and time management negatively impact their marriages. Similarly, adult ADHD may interfere with parenting in that parents with ADHD may have trouble maintaining their attention during interactions with their children or may overreact to their children’s tantrums. However, the role of parents for children with ADHD is critical. Parents of children with ADHD both assist in the delivery of pharmacological and behavioral treatments their children. Therefore, a parent’s own ADHD symptoms may interfere with their ability to deliver these vital resources to their child. Despite this research, little research has been conducted looking at effects of using stimulant medication to treat parents with ADHD who have children with ADHD. In fact, only one case study has examined the effects of treatment for parental ADHD on child treatment response. The current study seeks to examine the effect of a long-acting stimulant medication (Concerta) on mothers with ADHD who have children with ADHD. Mothers and children receive a free comprehensive ADHD assessment and mothers receive a free 7 week treatment of Concerta under the supervision of a physician.
Trial information was received from ClinicalTrials.gov and was last updated in September 2006.
Information provided to ClinicalTrials.gov by University of Maryland.