Last reviewed · How we verify
NCT01816074: TMF
Sequencing Treatments for Mothers With ADHD and Their At - Risk Children
Phase 4 trial testing Vyvanse (lisdexamphetamine) in Attention Deficit Hyperactivity Disorder in 53 participants. Completed in 1 May 2017.
1 October 2016
Quick facts
| Lead sponsor | Seattle Children's Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 53 |
| Start date | 1 October 2012 |
| Primary completion | 1 October 2016 |
| Estimated completion | 1 May 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Vyvanse (lisdexamphetamine) — full drug profile →
- Behavior Parent Training
Conditions studied
- Attention Deficit Hyperactivity Disorder — all drugs for Attention Deficit Hyperactivity Disorder →
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.
-
Child Behavioral Functioning
Time frame: Baseline, Weeks 8 and 16
Child symptom severity will be assessed using the Clinical Global Impression - Severity (CGI-s) scale. This was collected at Baseline, Week 8 (end of Phase 1) and Week 16 (end of Phase 2). The CGI-S scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse.
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):
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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 -
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
Verify or expand the search:
- PubMed search for NCT01816074
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Attention Deficit Hyperactivity Disorder
Currently open trials in the same condition.
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- NCT06325813 — ADHD PreSMA Response Inhibition Therapy · NA · recruiting
- NCT06248229 — A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder · Phase 4 · recruiting
- NCT06232226 — Attention Deficit Hyperactivity Disorder · NA · recruiting
Other Seattle Children's Hospital trials
Trials by the same sponsor.
- NCT07522112 — Evaluating a Shared Decision-making Intervention for Families About Firearm Storage · NA · not yet recruiting
- NCT06864611 — Evaluating Huddles as a Novel Approach to Improving Concussion Safety · NA · not yet recruiting
- NCT07424157 — Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products · not yet recruiting
- NCT07148050 — Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimer · Phase 1 · recruiting
- NCT07097792 — Concussion Recovery and Support Program · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01816074 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Seattle Children's Hospital
- Last refreshed: 10 September 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01816074.
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