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NCT01816074: TMF

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

Completed Phase 4 Results posted Last updated 10 September 2018
What this trial tests

Phase 4 trial testing Vyvanse (lisdexamphetamine) in Attention Deficit Hyperactivity Disorder in 53 participants. Completed in 1 May 2017.

Timeline
1 October 2012
Primary endpoint
1 October 2016
1 May 2017

Quick facts

Lead sponsorSeattle Children's Hospital
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment53
Start date1 October 2012
Primary completion1 October 2016
Estimated completion1 May 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Seattle Children's Hospital

Who can join

Adults 21 to 50, female only, with Attention Deficit Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Acute Effects of Parent Stimulant Medication Versus Behavioral Parent Training on Mothers' ADHD, Parenting Behavior, and At-Risk Children.
    Chronis-Tuscano A, French W, Strickland J, Sasser T, et al · · 2020 · cited 3× · PMID 32926603 · DOI 10.4088/jcp.19m13173
  2. Sequencing Stimulant Medication and Behavioral Parent Training in Multiplex ADHD Families: A Pilot SMART.
    Lui JHL, Chronis-Tuscano A, Almirall D, Whitlock KB, et al · · 2025 · cited 2× · PMID 40009046 · DOI 10.4088/jcp.24m15463

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Other recruiting trials for Attention Deficit Hyperactivity Disorder

Currently open trials in the same condition.

Other Seattle Children's Hospital trials

Trials by the same sponsor.

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