Efficacy of Concerta in Treating ADHD in Mothers of Children With ADHD
Primary Purpose
Adult ADHD
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Concerta
Sponsored by
About this trial
This is an interventional treatment trial for Adult ADHD focused on measuring Medication trial, ADHD, Concerta, Efficacy trial
Eligibility 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
Sites / Locations
- Children's National Medical Center Regional Outpatient Center
Outcomes
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)
Full Information
NCT ID
NCT00318981
First Posted
April 25, 2006
Last Updated
September 8, 2006
Sponsor
University of Maryland
Collaborators
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc., Children's National Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00318981
Brief Title
Efficacy of Concerta in Treating ADHD in Mothers of Children With ADHD
Official Title
Efficacy of Concerta in Treating ADHD in Mothers of Children With ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Maryland
Collaborators
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc., Children's National Research Institute
4. Oversight
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult ADHD
Keywords
Medication trial, ADHD, Concerta, Efficacy trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Non-Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Concerta
Primary Outcome Measure Information:
Title
Adult ADHD symptoms (Conners Adult ADHD Rating Scale)
Title
Impairment ratings (CGI)
Title
Side Effects (Pittsburgh Side Effect Scale)
Secondary Outcome Measure Information:
Title
Parenting measures (Parenting Stress Index, Alabama Parenting Questionnaire, O'Leary Parenting Scale, Observed Parent Child Interaction)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre M Chronis, PhD
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Medical Center Regional Outpatient Center
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19192455
Citation
Chronis-Tuscano A, Seymour KE, Stein MA, Jones HA, Jiles CD, Rooney ME, Conlon CJ, Efron LA, Wagner SA, Pian J, Robb AS. Efficacy of osmotic-release oral system (OROS) methylphenidate for mothers with attention-deficit/hyperactivity disorder (ADHD): preliminary report of effects on ADHD symptoms and parenting. J Clin Psychiatry. 2008 Dec;69(12):1938-47. doi: 10.4088/jcp.v69n1213. Epub 2008 Dec 2.
Results Reference
derived
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Efficacy of Concerta in Treating ADHD in Mothers of Children With ADHD
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