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NCT00000388: MTA
Multimodal Treatment Study of Children With ADHD
Phase 4 trial testing Psychosocial treatment in Attention Deficit Disorder With Hyperactivity. Completed in 1 November 1999.
Quick facts
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Primary purpose | treatment |
| Start date | 1 September 1998 |
| Estimated completion | 1 November 1999 |
Drugs / interventions tested
- Psychosocial treatment
- Anti-ADHD medication — full drug profile →
- Assessment-and-Referral
Conditions studied
- Attention Deficit Disorder With Hyperactivity — all drugs for Attention Deficit Disorder With Hyperactivity →
- Substance-related Disorders — all drugs for Substance-related Disorders →
- Dyssocial Behavior — all drugs for Dyssocial Behavior →
Sponsor
NYU Langone Health — full company profile →
Who can join
Adults 7 to 9, any sex, with Attention Deficit Disorder With Hyperactivity or Substance-related Disorders.
Sponsor's own description
This trial is a continuation of the Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (MTA Study). Continuation Aim 1 is to track the persistence of intervention-related effects as the MTA sample matures into mid-adolescence, including subsequent mental-health and school-related service utilization patterns as a function of MTA treatment experience (treatment assignment) and outcome (degree of treatment success at 14 mo.). Aim 2 is to test specific hypotheses about predictors, mediators, and moderators of long-term outcome among children with ADHD (e.g., comorbidity; family functioning; cognitive skills; peer relations) that may influence adolescent functioning (either independent of or through initial treatment assignment and/or 14-month treatment outcomes); and to compare how these predictors, mediators, and moderators are similar or dissimilar within the normal comparison group. Aim 3 is to track the patterns of risk and protective factors (including their mediation or moderation by initial treatment assignment and/or outcome) involved in early and subsequent stages of developing substance-related disorders and antisocial behavior. Aim 4 is to examine the effect of initial treatment assignment and degree of treatment success on later academic performance, achievement, school conduct, tendency to drop out, and other adverse school outcomes. In the original MTA design, patients were randomly assigned to 1 of 4 treatment conditions: (1) medication only; (2) psychosocial only; (3) combined (medication and psychosocial); or (4) Assessment-and-Referral condition. All but the latter were treated intensively for 14 months, with assessments for all subjects at baseline, 3, 9, 14, and 24 months. The original MTA design thus provides short-term (10 months post-treatment) follow-up at 24 months. This continuation extends the follow-up to assessments at 36, 60, and 84 months after treatment. A child may be eligible for this study if he/she: Is 7 - 9 years old, and has Attention Deficit Hyperactivity Disorder (ADHD).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
The MTA at 8 years: prospective follow-up of children treated for combined-type ADHD in a multisite study.
Molina BSG, Hinshaw SP, Swanson JM, Arnold LE, et al · · 2009 · cited 665× · PMID 19318991 · DOI 10.1097/chi.0b013e31819c23d0 -
Variable Patterns of Remission From ADHD in the Multimodal Treatment Study of ADHD.
Sibley MH, Arnold LE, Swanson JM, Hechtman LT, et al · · 2022 · cited 208× · PMID 34384227 · DOI 10.1176/appi.ajp.2021.21010032 -
Adolescent substance use in the multimodal treatment study of attention-deficit/hyperactivity disorder (ADHD) (MTA) as a function of childhood ADHD, random assignment to childhood treatments, and subsequent medication.
Molina BS, Hinshaw SP, Eugene Arnold L, Swanson JM, et al · · 2013 · cited 175× · PMID 23452682 · DOI 10.1016/j.jaac.2012.12.014 -
Late-Onset ADHD Reconsidered With Comprehensive Repeated Assessments Between Ages 10 and 25.
Sibley MH, Rohde LA, Swanson JM, Hechtman LT, et al · · 2018 · cited 107× · PMID 29050505 · DOI 10.1176/appi.ajp.2017.17030298 -
Treatment of children with attention-deficit/hyperactivity disorder (ADHD) and irritability: results from the multimodal treatment study of children with ADHD (MTA).
Fernández de la Cruz L, Simonoff E, McGough JJ, Halperin JM, et al · · 2015 · cited 82× · PMID 25524791 · DOI 10.1016/j.jaac.2014.10.006 -
Social skills training for attention deficit hyperactivity disorder (ADHD) in children aged 5 to 18 years.
Storebø OJ, Elmose Andersen M, Skoog M, Joost Hansen S, et al · · 2019 · cited 59× · PMID 31222721 · DOI 10.1002/14651858.cd008223.pub3 -
Trajectories of Growth Associated With Long-Term Stimulant Medication in the Multimodal Treatment Study of Attention-Deficit/Hyperactivity Disorder.
Greenhill LL, Swanson JM, Hechtman L, Waxmonsky J, et al · · 2020 · cited 48× · PMID 31421233 · DOI 10.1016/j.jaac.2019.06.019 -
Eight-Year Latent Class Trajectories of Academic and Social Functioning in Children with Attention-Deficit/Hyperactivity Disorder.
DuPaul GJ, Morgan PL, Farkas G, Hillemeier MM, et al · · 2018 · cited 20× · PMID 28913744 · DOI 10.1007/s10802-017-0344-z
Verify or expand the search:
- PubMed search for NCT00000388
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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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 NCT00000388 (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 NYU Langone Health
- Last refreshed: 28 September 2015
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/NCT00000388.
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