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
| Type | Name | Description |
|---|---|---|
| DRUG | Vyvanse (lisdexamphetamine) | Active ADHD drug, Vyvanse, is administered to mother. |
| BEHAVIORAL | Behavior Parent Training | Mother 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.