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NCT01816074 · ClinicalTrials.gov registry record · Phase 4
Sequencing Treatments for Mothers With ADHD and Their At - Risk Children
A Phase 4 study, sponsored by Seattle Children's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 53
- Enrollment target
NCT01816074: Completed Phase 4 study, sponsored by Seattle Children's Hospital.
NCT01816074 is a Phase 4 study that has completed, run by Seattle Children's Hospital. The registered enrollment target is 53 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01816074, a Phase 4 study, has completed, sponsored by Seattle Children's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 53 participants
- Enrollment target
Study Summary
We hypothesize that successfully treating maternal Attention Deficit Hyperactivity Disorder (ADHD) will have a beneficial effect that extends to the child. We believe that multi-component interventions combining maternal stimulant medication, Lisdexamfetamine (LDX), and Behavioral Parent Training (BPT) will improve parenting, maternal, and child outcomes. In terms of improved parenting, we hypothesize that some mothers may respond well to LDX or BPT alone and therefore may not require multi-modal treatment, whereas others may benefit most from multi-modal treatment
Primary Outcome
Child symptom severity will be assessed using the Clinical Global Impression - Severity (CGI-s) scale. This was collected at Baseline, Week 8 (end of Phase 1) and Week 16 (end of Phase 2). The CGI-S scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse.
Interventions
- DRUG Vyvanse (lisdexamphetamine)
- BEHAVIORAL Behavior Parent Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2012-10 |
| Est. Completion | 2017-05-01 |
| Phase | Phase 4 |
What the finished NCT01816074 record still lists
NCT01816074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Vyvanse (lisdexamphetamine) is the first listed.
NCT01816074 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01816074 about?
NCT01816074 is a clinical study titled "Sequencing Treatments for Mothers With ADHD and Their At - Risk Children". We hypothesize that successfully treating maternal Attention Deficit Hyperactivity Disorder (ADHD) will have a beneficial effect that extends to the child. We believe that multi-component interventions combining maternal stimulant medication, Lisdexamfetamine (LDX), and Behavioral Parent Training (B...
What is the current status of trial NCT01816074?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 53 participants. The study started on 2012-10. Estimated completion is 2017-05-01.
What interventions are being tested in trial NCT01816074?
The interventions under investigation include: Vyvanse (lisdexamphetamine) (DRUG), Behavior Parent Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT01816074?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01816074's enrollment target sits among peer trials
53 1229th of 2000 higher than 768 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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