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

NCT01816074 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2018-10-09

Study results available
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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

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

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

Sponsors & Collaborators

  • Shire

    collaborator INDUSTRY

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Mark A Stein, PhD · Seattle Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-10-31
Completion
2017-05-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01816074 on ClinicalTrials.gov