Phase 4
N=41
Sequencing Treatments for Mothers With ADHD and Their At - Risk Children
Attention Deficit Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01816074 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Child Behavioral Functioning — 4.78; 4.56; 4.44; 4.67 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vyvanse (lisdexamphetamine) (Drug); Behavior Parent Training (Behavioral)
- Age
- Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Seattle Children's Hospital
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Child Behavioral Functioning |
4.78; 4.56; 4.44; 4.67; 4.33; 3.75 | — |
| SECONDARY Maternal Behavioral Functioning |
4.64; 4.50; 4.82; 4.45; 3.55; 3.67 | — |
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
Eligibility Criteria
Mothers Inclusion Criteria:
- Sign informed consent
- Be between 21-50 years old (inclusive) at the screening visit and English-speaking
- At screening (after washout, if required) meet full Diagnostic and Statistical Manual (DSM-IV) criteria for ADHD, any subtype
- Have current CGI-S-ADHD rating > 4 and 60), no prior treatment with effective doses of stimulants, defined as one or more weeks of treatment with adequate doses.
Data sourced from ClinicalTrials.gov (NCT01816074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.