| Conditions: |
|
ADHD |
| Purpose: |
|
It is now well recognized that Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic
disorder of childhood that extends into adulthood for many individuals. A number of
impairments in daily life functioning have been identified in adults with ADHD, including
marital distress, risky driving, and using less effective parenting practices (e.g.,
Barkley, 2006).
Specifically, some parents with ADHD have been found to use inconsistent discipline, less
parental involvement, and less positive reinforcement with their children compared to
parents without ADHD (e.g., Chen & Johnston, 2007; Chronis-Tuscano, Clarke, Rooney, Diaz, &
Pian, 2008). While there is some evidence that stimulant medication improves parental
functioning for adults with ADHD, only one study has specifically explored the use of
stimulant medication and parenting(Chronis-Tuscano, Seymour, Stine, Jones, Jiles, Rooney, et
al., 2008).
The purpose of this study is to explore whether or not the stimulant medication,
lisdexamfetamine, improves parent functioning. Measures of parenting behavior, parental
psychosocial functioning, and child psychosocial functioning will be collected. It is
hypothesized that lisdexamfetamine will be associated with some improvement in these
assessments.
|
| Study Summary: |
|
Seventy families with at least one parent (either mother or father who will serve as the
identified subject) and a school-aged child (ages 5-16) with ADHD will be recruited to
participate in a randomized, placebo-controlled trial of lisdexamfetamine to assess the
acute and prolonged effects of medication usage on parent-child interactions. The protocol
will employ traditional self-report measures of parental competency and functioning used in
other studies, but will supplement them with one of the most widely used observational
laboratory tasks.
Families will be recruited on a rolling basis and the length of the study will be
approximately 8 weeks. In the first three weeks of the study, parents will complete the dose
optimization phase to find the optimal dose of lisdexamfetamine (phase 1). Lisdexamfetamine
will be initiated at a dose of 30mg and increased to 50mg for week 2 and 70mg for week 3.
During week 4, measures of the acute effects of lisdexamfetamine will be collected, and
parents will complete the observational laboratory parent child interaction tasks two times
(i.e., on lisdexamfetamine and on placebo). In the remaining four weeks of the study (phase
2) a between subjects comparison will be conducted. Half of the parents will be randomized
to receive lisdexamfetamine and half will receive a placebo. Measures of parent functioning
will once again be collected at the end of phase 2 and parents will complete the
observational laboratory task, which will allow for exploration of prolonged
lisdexamfetamine treatment on parent-child interactions.
|
| Criteria: |
|
Inclusion Criteria:
- Parents with a diagnosis of ADHD, who also have a child with an ADHD between the ages
of 5-16
Exclusion Criteria:
- Parents with any of the following: any identified structural heart abnormality or
other health condition that significantly affects heart performance (e.g.,
hypertension), a resting systolic blood pressure ≥140 and diastolic blood pressure
≥90, pregnant or breast feeding, significant psychiatric problems other than ADHD
that currently require medication or any emergent psychiatric treatment,
medical/psychiatric illness that could be worsened by stimulants (such as a seizure
disorder, Tourette's Disorder or hyperthyroidism), or alcohol or substance abuse
problems in the past 6 months.
- Children with any of the following: any psychiatric problem other than ADHD,
Oppositional Defiant Disorder (ODD), or Conduct Disorder (CD) that requires
medication or any emergent psychiatric treatment, either parent or child has
participated in the same parent-child interaction task used in this study in the last
6 months, either as part of a study or a clinical treatment.
|
| NCT ID: |
|
NCT01127607 |
| Primary Contact: |
|
Principal Investigator
James G Waxmonsky, M.D.
Florida International University
James G Waxmonsky, M.D.
Phone: 716 829 2244 ext. 142
Email: jgw@buffalo.edu
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Miami, Florida 33199
United States
Daniel Bolea
Phone: 305-348-0477
Site Status: Recruiting |