CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 53 enrolled
Drug / intervention
Vyvanse (lisdexamphetamine) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01816074
NCT01816074Phase 4Completed
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Sequencing Treatments for Mothers With ADHD and Their At - Risk Children

Seattle Children's Hospital·interventional·Posted Mar 21, 2013·Updated Oct 9, 2018

In Brief

A Phase 4 clinical trial evaluating Vyvanse (lisdexamphetamine) and Behavior Parent Training for Attention Deficit Hyperactivity Disorder. Completed, enrolled 53 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesUnited States
CollaboratorsShire

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 21, 2013
Enrollment StartOct 1, 2012
Primary CompletionOct 1, 2016
Study CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 13.3 years ago

Interventions

Vyvanse (lisdexamphetamine)drug

Active ADHD drug, Vyvanse, is administered to mother.

Behavior Parent Trainingbehavioral

Mother is given 8 weeks of individual sessions of behavioral parent training