Efficacy of Concerta in Treating ADHD in Mothers of Children With ADHD
Information source: University of Maryland
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adult ADHD
Intervention: Concerta (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: University of Maryland Official(s) and/or principal investigator(s):
Andre M Chronis, PhD, Principal Investigator, Affiliation: University of Maryland, College Park
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
Clinical Details
Official title: Efficacy of Concerta in Treating ADHD in Mothers of Children With ADHD
Study design: Treatment, Non-Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Adult ADHD symptoms (Conners Adult ADHD Rating Scale)Impairment ratings (CGI) Side Effects (Pittsburgh Side Effect Scale)
Secondary outcome: Parenting measures (Parenting Stress Index, Alabama Parenting Questionnaire, O'Leary Parenting Scale, Observed Parent Child Interaction)
Detailed 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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Children's National Medical Center Regional Outpatient Center, Fairfax, Virginia 22031, United States
Additional Information
University of Maryland ADHD Program
Starting date: December 2004
Ending date: December 2006
Last updated: September 8, 2006
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