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NCT01127607 · ClinicalTrials.gov registry record · Phase 4
Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?
A Phase 4 study of ADHD, sponsored by Florida International University.
- Completed
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT01127607: Completed Phase 4 study of ADHD, sponsored by Florida International University.
NCT01127607 is a Phase 4 study of ADHD that has completed, run by Florida International University. The registered enrollment target is 38 participants, below the 190-participant average among 75 other ADHD trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01127607, a Phase 4 study of ADHD, has completed, sponsored by Florida International University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors. Average number of behaviors per group were computed. Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome i
Conditions Studied
Interventions
- DRUG lisdexamfetamine
Study Locations (1)
Florida
- Florida International University - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-07 |
| Phase | Phase 4 |
What the finished NCT01127607 record still lists
NCT01127607 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 190-participant average among 75 other ADHD trials with a reported enrollment target (80% lower).
The record links to 1 condition, with ADHD appearing as the primary indexed condition, and to 1 intervention - of which lisdexamfetamine is the first listed.
NCT01127607 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01127607 about?
NCT01127607 is a clinical study titled "Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?". 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, a...
What is the current status of trial NCT01127607?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2010-11. Estimated completion is 2012-07.
What conditions does trial NCT01127607 study?
This clinical trial studies the following conditions: ADHD.
What interventions are being tested in trial NCT01127607?
The interventions under investigation include: lisdexamfetamine (DRUG).
Who is sponsoring clinical trial NCT01127607?
This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01127607 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for ADHD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01127607's enrollment target sits among peer trials
38 54th of 75 higher than 22 of 75 other ADHD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other ADHD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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