Clinical Trials Directory

Trials / Completed

CompletedNCT01816074

Sequencing Treatments for Mothers With ADHD and Their At - Risk Children

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
53 (actual)
Sponsor
Seattle Children's Hospital · Academic / Other
Sex
Female
Age
21 Years – 50 Years
Healthy volunteers
Not accepted

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

Detailed description

The overarching goal of this study is to construct and evaluate an adaptive intervention (i.e., an individualized treatment protocol that is adjusted based on the child-mother dyad's initial response to treatment) to improve the trajectory of ADHD outcomes in at-risk children. Our primary outcome measure for the child will be whether child ADHD symptoms on the Conners Parent and Teacher Rating Scales decreased at the completion of the study. Our secondary outcome measure will be whether there was a need for medication for the child over the course of the study. The primary outcome for the mother will be the Conners Adult ADHD Rating Scale (CAARS) Attention Scale and the Clinical Global Impression-Severity scale (CGI-S).

Conditions

Interventions

TypeNameDescription
DRUGVyvanse (lisdexamphetamine)Active ADHD drug, Vyvanse, is administered to mother.
BEHAVIORALBehavior Parent TrainingMother is given 8 weeks of individual sessions of behavioral parent training

Timeline

Start date
2012-10-01
Primary completion
2016-10-01
Completion
2017-05-01
First posted
2013-03-21
Last updated
2018-10-09
Results posted
2018-05-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01816074. Inclusion in this directory is not an endorsement.