Efficacy of Concerta in Treating ADHD in Mothers of Children With ADHD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by University of Maryland.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Children's Research Institute
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT00318981
First received: April 25, 2006
Last updated: September 8, 2006
Last verified: September 2006
  Purpose

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


Condition Intervention Phase
Adult ADHD
Drug: Concerta
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy of Concerta in Treating ADHD in Mothers of Children With ADHD

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Adult ADHD symptoms (Conners Adult ADHD Rating Scale)
  • Impairment ratings (CGI)
  • Side Effects (Pittsburgh Side Effect Scale)

Secondary Outcome Measures:
  • Parenting measures (Parenting Stress Index, Alabama Parenting Questionnaire, O'Leary Parenting Scale, Observed Parent Child Interaction)

Estimated Enrollment: 40
Study Start Date: December 2004
Estimated Study Completion Date: December 2006
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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318981

Locations
United States, Virginia
Children's National Medical Center Regional Outpatient Center
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
University of Maryland
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Children's Research Institute
Investigators
Principal Investigator: Andre M Chronis, PhD University of Maryland, College Park
  More Information

No publications provided by University of Maryland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00318981     History of Changes
Other Study ID Numbers: IIS-2003-023
Study First Received: April 25, 2006
Last Updated: September 8, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Maryland:
Medication trial
ADHD
Concerta
Efficacy trial

Additional relevant MeSH terms:
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014