Attention Deficit Disorder With HyperactivityPhase 4MTANCT00000388
Multimodal Treatment Study of Children With Attention Deficit and Hyperactivity Disorder (MTA)
A Phase 4 study testing Psychosocial treatment, Anti-ADHD medication and Assessment-and-Referral in people with Attention Deficit Disorder With Hyperactivity and Substance-related Disorders, run by NYU Langone Health.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 7 to 9 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Substance-related Disorders, Dyssocial Behavior
- What is being tested?
- Psychosocial treatment, Anti-ADHD medication and Assessment-and-Referral
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1998to Nov 1999
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 9 years
- All sexes
- Child
Who may be able to join
- -
- Patients must have:
- Rigorously diagnosed Attention Deficit Hyperactivity Disorder (ADHD).
Who cannot join
None listed.
About this study
Official title: Multimodal Treatment Study of Children With ADHD
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.
Read more
A child may be eligible for this study if he/she:
Is 7 - 9 years old, and has Attention Deficit Hyperactivity Disorder (ADHD).
Read the detailed 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.
- Conditions
- Attention Deficit Disorder With Hyperactivity, Substance-related Disorders, Dyssocial Behavior
- Being tested
- Psychosocial treatment, Anti-ADHD medication, Assessment-and-Referral
- Keywords
- Attention Deficit Disorder with Hyperactivity, Adolescence, Child, Cognition, Combined Modality Therapy, Female, Human, Male, Peer Group, Risk Factors, Treatment Outcome, Attention Deficit Disorder with Hyperactivity -- *therapy, Attention Deficit Disorder with Hyperactivity -- drug therapy, Attention Deficit Disorder with Hyperactivity -- psychology
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Substance-Related Disorders, Antisocial Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial treatmentBehavioural
Anti-ADHD medicationDrug
Assessment-and-ReferralBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study startSep 1998
- Study completionNov 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (89)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Howard B. Abikoff, PhD, Principal investigatorC. Keith Conners, Principal investigatorLaurence L. Greenhill, MD, Principal investigatorStephen P. Hinshaw, PhD, Principal investigatorWilliam E. Pelham, PhD, Principal investigatorJames M. Swanson, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000388
- Sponsor's protocol ID
- U01MH050453
- Other IDs
- U01MH050453, MH50447, MH50454, MH50461, MH50467, MH50440, DSIR CT
- Acronym
- MTA
- Status last verified
- Sep 2015
- First submitted
- 2 Nov 1999
- Last updated
- 29 Sep 2015
- Results posted
- No
Publications
Kolko DJ, Bukstein OG, Barron J. Methylphenidate and behavior modification in children with ADHD and comorbid ODD or CD: main and incremental effects across settings. J Am Acad Child Adolesc Psychiatry. 1999 May;38(5):578-86. doi: 10.1097/00004583-199905000-00020.
PubMed 10230190Epstein JN, Conners CK, Erhardt D, Arnold LE, Hechtman L, Hinshaw SP, Hoza B, Newcorn JH, Swanson JM, Vitiello B. Familial aggregation of ADHD characteristics. J Abnorm Child Psychol. 2000 Dec;28(6):585-94. doi: 10.1023/a:1005187216138.
PubMed 11104319Hoza B, Owens JS, Pelham WE, Swanson JM, Conners CK, Hinshaw SP, Arnold LE, Kraemer HC. Parent cognitions as predictors of child treatment response in attention-deficit/hyperactivity disorder. J Abnorm Child Psychol. 2000 Dec;28(6):569-83. doi: 10.1023/a:1005135232068.
PubMed 11104318Paule MG, Rowland AS, Ferguson SA, Chelonis JJ, Tannock R, Swanson JM, Castellanos FX. Attention deficit/hyperactivity disorder: characteristics, interventions and models. Neurotoxicol Teratol. 2000 Sep-Oct;22(5):631-51. doi: 10.1016/s0892-0362(00)00095-7.
PubMed 11106857Pelham WE, Gnagy EM, Greiner AR, Hoza B, Hinshaw SP, Swanson JM, Simpson S, Shapiro C, Bukstein O, Baron-Myak C, McBurnett K. Behavioral versus behavioral and pharmacological treatment in ADHD children attending a summer treatment program. J Abnorm Child Psychol. 2000 Dec;28(6):507-25. doi: 10.1023/a:1005127030251.
PubMed 11104314Abikoff H. Tailored psychosocial treatments for ADHD: the search for a good fit. J Clin Child Psychol. 2001 Mar;30(1):122-5. doi: 10.1207/S15374424JCCP3001_14.
PubMed 11294070Hoza B. Psychosocial treatment issues in the MTA: a reply to Greene and Ablon. J Clin Child Psychol. 2001 Mar;30(1):126-30. doi: 10.1207/S15374424JCCP3001_15.
PubMed 11294071Jensen PS, Hinshaw SP, Swanson JM, Greenhill LL, Conners CK, Arnold LE, Abikoff HB, Elliott G, Hechtman L, Hoza B, March JS, Newcorn JH, Severe JB, Vitiello B, Wells K, Wigal T. Findings from the NIMH Multimodal Treatment Study of ADHD (MTA): implications and applications for primary care providers. J Dev Behav Pediatr. 2001 Feb;22(1):60-73. doi: 10.1097/00004703-200102000-00008.
PubMed 11265923Marcus, S. M., & Gibbons, R. D. (2001). Estimating the efficacy of receiving treatment in randomized clinical trials with noncompliance. Health Services and Outcomes Research Methodology, 2(3-4), 247-258.
Newcorn JH, Halperin JM, Jensen PS, Abikoff HB, Arnold LE, Cantwell DP, Conners CK, Elliott GR, Epstein JN, Greenhill LL, Hechtman L, Hinshaw SP, Hoza B, Kraemer HC, Pelham WE, Severe JB, Swanson JM, Wells KC, Wigal T, Vitiello B. Symptom profiles in children with ADHD: effects of comorbidity and gender. J Am Acad Child Adolesc Psychiatry. 2001 Feb;40(2):137-46. doi: 10.1097/00004583-200102000-00008.
PubMed 11214601Johnston C, Murray C, Hinshaw SP, William EP Jr, Hoza B. Responsiveness in interactions of mothers and sons with ADHD: relations to maternal and child characteristics. J Abnorm Child Psychol. 2002 Feb;30(1):77-88. doi: 10.1023/a:1014235200174.
PubMed 11930974Arnold LE, Elliot M, Sachs L, Bird H, Kraemer HC, Wells KC, Abikoff HB, Comarda A, Conners CK, Elliott GR, Greenhill LL, Hechtman L, Hindshaw SP, Hoza B, Jensen PS, March JS, Newcorn JH, Pelham WE, Severe JB, Swanson JM, Vitiello B, Wigal T. Effects of ethnicity on treatment attendance, stimulant response/dose, and 14-month outcome in ADHD. J Consult Clin Psychol. 2003 Aug;71(4):713-27. doi: 10.1037/0022-006x.71.4.713.
PubMed 12924677Hoza B, Gerdes AC, Hinshaw SP, Arnold LE, Pelham WE Jr, Molina BS, Abikoff HB, Epstein JN, Greenhill LL, Hechtman L, Odbert C, Swanson JM, Wigal T. Self-perceptions of competence in children with ADHD and comparison children. J Consult Clin Psychol. 2004 Jun;72(3):382-91. doi: 10.1037/0022-006X.72.3.382.
PubMed 15279522MTA Cooperative Group. National Institute of Mental Health Multimodal Treatment Study of ADHD follow-up: 24-month outcomes of treatment strategies for attention-deficit/hyperactivity disorder. Pediatrics. 2004 Apr;113(4):754-61. doi: 10.1542/peds.113.4.754.
PubMed 15060224Newcorn, J. H. (2004). Comorbidity of ADHD and disruptive behavior disorders: Prevalence, impact, and management options. Drug Benefit Trends, 16(8), 431-436.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Treatment Study of Children With ADHD
- ClinicalTrials.gov ID
- NCT00000388
- Acronym / sponsor ID
- MTA / U01MH050453
- Conditions
- Attention Deficit Disorder With Hyperactivity, Substance-related Disorders, Dyssocial Behavior
- Keywords
- Attention Deficit Disorder with Hyperactivity, Adolescence, Child, Cognition, Combined Modality Therapy, Female, Human, Male
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 1998
- Study completion
- Nov 1999
- First posted
- 3 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (3 listed)
- -
- Rigorously diagnosed Attention Deficit Hyperactivity Disorder (ADHD).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial treatment | Behavioural | – |
| Anti-ADHD medication | Drug | – |
| Assessment-and-Referral | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
- Background: PubMed 10230190Kolko DJ, Bukstein OG, Barron J. Methylphenidate and behavior modification in children with ADHD and comorbid ODD or CD: main and incremental effects across settings. J Am Acad Child Adolesc Psychiatry. 1999 May;38(5):578-86. doi: 10.1097/00004583-199905000-00020.
- Background: PubMed 11104319Epstein JN, Conners CK, Erhardt D, Arnold LE, Hechtman L, Hinshaw SP, Hoza B, Newcorn JH, Swanson JM, Vitiello B. Familial aggregation of ADHD characteristics. J Abnorm Child Psychol. 2000 Dec;28(6):585-94. doi: 10.1023/a:1005187216138.
- Background: PubMed 11104318Hoza B, Owens JS, Pelham WE, Swanson JM, Conners CK, Hinshaw SP, Arnold LE, Kraemer HC. Parent cognitions as predictors of child treatment response in attention-deficit/hyperactivity disorder. J Abnorm Child Psychol. 2000 Dec;28(6):569-83. doi: 10.1023/a:1005135232068.
- Background: PubMed 11106857Paule MG, Rowland AS, Ferguson SA, Chelonis JJ, Tannock R, Swanson JM, Castellanos FX. Attention deficit/hyperactivity disorder: characteristics, interventions and models. Neurotoxicol Teratol. 2000 Sep-Oct;22(5):631-51. doi: 10.1016/s0892-0362(00)00095-7.
- Background: PubMed 11104314Pelham WE, Gnagy EM, Greiner AR, Hoza B, Hinshaw SP, Swanson JM, Simpson S, Shapiro C, Bukstein O, Baron-Myak C, McBurnett K. Behavioral versus behavioral and pharmacological treatment in ADHD children attending a summer treatment program. J Abnorm Child Psychol. 2000 Dec;28(6):507-25. doi: 10.1023/a:1005127030251.
- Background: PubMed 11294070Abikoff H. Tailored psychosocial treatments for ADHD: the search for a good fit. J Clin Child Psychol. 2001 Mar;30(1):122-5. doi: 10.1207/S15374424JCCP3001_14.
- Background: PubMed 11294071Hoza B. Psychosocial treatment issues in the MTA: a reply to Greene and Ablon. J Clin Child Psychol. 2001 Mar;30(1):126-30. doi: 10.1207/S15374424JCCP3001_15.
- Background: PubMed 11265923Jensen PS, Hinshaw SP, Swanson JM, Greenhill LL, Conners CK, Arnold LE, Abikoff HB, Elliott G, Hechtman L, Hoza B, March JS, Newcorn JH, Severe JB, Vitiello B, Wells K, Wigal T. Findings from the NIMH Multimodal Treatment Study of ADHD (MTA): implications and applications for primary care providers. J Dev Behav Pediatr. 2001 Feb;22(1):60-73. doi: 10.1097/00004703-200102000-00008.
- BackgroundMarcus, S. M., & Gibbons, R. D. (2001). Estimating the efficacy of receiving treatment in randomized clinical trials with noncompliance. Health Services and Outcomes Research Methodology, 2(3-4), 247-258.
- Background: PubMed 11214601Newcorn JH, Halperin JM, Jensen PS, Abikoff HB, Arnold LE, Cantwell DP, Conners CK, Elliott GR, Epstein JN, Greenhill LL, Hechtman L, Hinshaw SP, Hoza B, Kraemer HC, Pelham WE, Severe JB, Swanson JM, Wells KC, Wigal T, Vitiello B. Symptom profiles in children with ADHD: effects of comorbidity and gender. J Am Acad Child Adolesc Psychiatry. 2001 Feb;40(2):137-46. doi: 10.1097/00004583-200102000-00008.
- Background: PubMed 11930974Johnston C, Murray C, Hinshaw SP, William EP Jr, Hoza B. Responsiveness in interactions of mothers and sons with ADHD: relations to maternal and child characteristics. J Abnorm Child Psychol. 2002 Feb;30(1):77-88. doi: 10.1023/a:1014235200174.
- Background: PubMed 12924677Arnold LE, Elliot M, Sachs L, Bird H, Kraemer HC, Wells KC, Abikoff HB, Comarda A, Conners CK, Elliott GR, Greenhill LL, Hechtman L, Hindshaw SP, Hoza B, Jensen PS, March JS, Newcorn JH, Pelham WE, Severe JB, Swanson JM, Vitiello B, Wigal T. Effects of ethnicity on treatment attendance, stimulant response/dose, and 14-month outcome in ADHD. J Consult Clin Psychol. 2003 Aug;71(4):713-27. doi: 10.1037/0022-006x.71.4.713.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard B. Abikoff, PhD principal investigator
C. Keith Conners principal investigator
Laurence L. Greenhill, MD principal investigator
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Psychosocial treatment, Anti-ADHD medication and Assessment-and-Referral in people with Attention Deficit Disorder With Hyperactivity and Substance-related Disorders, run by NYU Langone Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000388, which also lists 89 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2015.