Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children (PATS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-01

Study Completion Date

2006-11-30

Brief Summary

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This research focuses on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in very young children. The medication being used is methylphenidate (Ritalin); it is being studied to determine its safety and how well it works to treat ADHD in preschool-age children (3-5.5 year olds).

Detailed Description

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Young children age 3-5.5 years will be studied. The study includes treatment with different doses of methylphenidate and placebo; all children will receive active medication during the study. Prior to treatment, each child will receive a thorough psychiatric evaluation and each guardian will complete a 10-week workshop (2 hours/week). Throughout the study, parents and teachers will complete forms that report on the child's behavior and possible side effects. Participants will be monitored by regular visits with a study physician. Most participants will be involved in the study for up to 16 months to ensure optimal evaluation, dosing, and monitoring

Conditions

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Attention Deficit Disorder With Hyperactivity

Keywords

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Methylphenidate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Boys and girls who are:

* Between the ages of 3-5.5 years
* Qualified as having ADHD by our diagnostic evaluations and clinical staff
* Otherwise generally healthy
* Willing, and have parents that are willing, to attend all visits required by the study
* Enrolled in some type of day-program: day care, preschool, nursery school, kindergarten, for at least 2 half days/week
* In classrooms with teachers that are willing to participate by completing rating scale

Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Laurence Greenhill

Professor of Clinical Child and Adolescent Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laurence Greenhill, M.D.

Role: STUDY_CHAIR

Locations

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University of California, Irvine

Irvine, California, United States

Site Status

University of California, Los Angeles

Los Angeles, California, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

New York State Psychiatric Institute

New York, New York, United States

Site Status

New York University School of Medicine

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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Schleifer M, Weiss G, Cohen N, Elman M, Cvejic H, Kruger E. Hyperactivity in preschoolers and the effect of methylphenidate. Am J Orthopsychiatry. 1975 Jan;45(1):38-50. doi: 10.1111/j.1939-0025.1975.tb01164.x.

Reference Type BACKGROUND

PMID: 1089359 (View on PubMed)

Handen BL, Feldman HM, Lurier A, Murray PJ. Efficacy of methylphenidate among preschool children with developmental disabilities and ADHD. J Am Acad Child Adolesc Psychiatry. 1999 Jul;38(7):805-12. doi: 10.1097/00004583-199907000-00009.

Reference Type BACKGROUND

PMID: 10405497 (View on PubMed)

Conners CK: Controlled trial of methylphenidate in preschool children with minimal brain dysfunction. Int J Ment Health (4):61-74, 1975.

Reference Type BACKGROUND

Barkley RA. The effects of methylphenidate on the interactions of preschool ADHD children with their mothers. J Am Acad Child Adolesc Psychiatry. 1988 May;27(3):336-41. doi: 10.1097/00004583-198805000-00012. No abstract available.

Reference Type BACKGROUND

PMID: 3379016 (View on PubMed)

Mayes SD, Crites DL, Bixler EO, Humphrey FJ 2nd, Mattison RE. Methylphenidate and ADHD: influence of age, IQ and neurodevelopmental status. Dev Med Child Neurol. 1994 Dec;36(12):1099-107. doi: 10.1111/j.1469-8749.1994.tb11811.x.

Reference Type BACKGROUND

PMID: 7525394 (View on PubMed)

Musten LM, Firestone P, Pisterman S, Bennett S, Mercer J. Effects of methylphenidate on preschool children with ADHD: cognitive and behavioral functions. J Am Acad Child Adolesc Psychiatry. 1997 Oct;36(10):1407-15. doi: 10.1097/00004583-199710000-00023.

Reference Type BACKGROUND

PMID: 9334554 (View on PubMed)

Kollins S, Greenhill L, Swanson J, Wigal S, Abikoff H, McCRACKEN J, Riddle M, McGOUGH J, Vitiello B, Wigal T, Skrobala A, Posner K, Ghuman J, Davies M, Cunningham C, Bauzo A. Rationale, design, and methods of the Preschool ADHD Treatment Study (PATS). J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1275-1283. doi: 10.1097/01.chi.0000235074.86919.dc.

Reference Type RESULT

PMID: 17023869 (View on PubMed)

Swanson J, Greenhill L, Wigal T, Kollins S, Stehli A, Davies M, Chuang S, Vitiello B, Skrobala A, Posner K, Abikoff H, Oatis M, McCRACKEN J, McGOUGH J, Riddle M, Ghuman J, Cunningham C, Wigal S. Stimulant-related reductions of growth rates in the PATS. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1304-1313. doi: 10.1097/01.chi.0000235075.25038.5a.

Reference Type RESULT

PMID: 17023868 (View on PubMed)

Greenhill L, Kollins S, Abikoff H, McCracken J, Riddle M, Swanson J, McGough J, Wigal S, Wigal T, Vitiello B, Skrobala A, Posner K, Ghuman J, Cunningham C, Davies M, Chuang S, Cooper T. Efficacy and safety of immediate-release methylphenidate treatment for preschoolers with ADHD. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1284-1293. doi: 10.1097/01.chi.0000235077.32661.61.

Reference Type RESULT

PMID: 17023867 (View on PubMed)

McGOUGH J, McCRACKEN J, Swanson J, Riddle M, Kollins S, Greenhill L, Abikoff H, Davies M, Chuang S, Wigal T, Wigal S, Posner K, Skrobala A, Kastelic E, Ghuman J, Cunningham C, Shigawa S, Moyzis R, Vitiello B. Pharmacogenetics of methylphenidate response in preschoolers with ADHD. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1314-1322. doi: 10.1097/01.chi.0000235083.40285.08.

Reference Type RESULT

PMID: 17023870 (View on PubMed)

Wigal T, Greenhill L, Chuang S, McGOUGH J, Vitiello B, Skrobala A, Swanson J, Wigal S, Abikoff H, Kollins S, McCRACKEN J, Riddle M, Posner K, Ghuman J, Davies M, Thorp B, Stehli A. Safety and tolerability of methylphenidate in preschool children with ADHD. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1294-1303. doi: 10.1097/01.chi.0000235082.63156.27.

Reference Type RESULT

PMID: 17028508 (View on PubMed)