Rationale, design, and methods of the Preschool ADHD Treatment Study (PATS)

Journal of the American Academy of Child and Adolescent Psychiatry

Volumn 45, Issue 11, 2006, Pages 1275-1283

  Kollins, Scott ^a   Greenhill, Laurence ^b   Swanson, James ^c   Wigal, Sharon ^c   Abikoff, Howard ^d   McCracken, James ^e   Riddle, Mark ^f   McGough, James ^e   Vitiello, Benedetto ^g   Wigal, Tim ^c   Skrobala, Anne ^b   Posner, Kelly ^b   Ghuman, Jaswinder ^h   Davies, Mark ^b   Cunningham, Charles ⁱ   Bauzo, Audrey ^j  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b NEW YORK STATE PSYCHIATRIC INSTITUTE   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d NEW YORK UNIVERSITY   (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f JOHNS HOPKINS UNIVERSITY   (United States)

^g NATIONAL INSTITUTE OF MENTAL HEALTH   (United States)

^h UNIVERSITY OF ARIZONA   (United States)

ⁱ MCMASTER UNIVERSITY   (Canada)

^j NATHAN S KLINE INSTITUTE FOR PSYCHIATRIC RESEARCH   (United States)

more..

Author keywords

Attention deficit hyperactivity disorder; Clinical trials; Methylphenidate; Preschool

Indexed keywords

METHYLPHENIDATE;

ARTICLE; ATTENTION DEFICIT DISORDER; CHILD BEHAVIOR; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; HUMAN; HYPERACTIVITY; MAJOR CLINICAL STUDY; MENTAL HEALTH CARE; MULTICENTER STUDY; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ATTENTION DEFICIT DISORDER WITH HYPERACTIVITY; CENTRAL NERVOUS SYSTEM STIMULANTS; CHILD; CHILD, PRESCHOOL; CLINICAL TRIALS; FEMALE; HUMANS; MALE; METHYLPHENIDATE; RESEARCH DESIGN;

EID: 33750512365     PISSN: 08908567     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.chi.0000235074.86919.dc     Document Type: Article

References (65)

1. AACAP (1997), Practice parameters for the assessment and treatment of children, adolescents, and adults with attention-deficit/hyperactivity disorder. American Academy of Child and Adolescent Psychiatry. J Am Acad Child Adolesc Psychiatry 36(Suppl):85S-121S
2. Abidin RR (1990), The Parenting Stress Index, 3rd ed. Lutz, FL: Psychological Assessment Resources, Inc.
3. Abikoff H, Gittelman R, Klein DF (1980), Classroom observation code for hyperactive children: a replication of validity. J Consult Clin Psychol 48:555-565
4. Achenbach TM (1991), Manual for the Teacher's Report Form and 1991 Profile. Burlington, VT: University of Vermont, Department of Psychiatry
5. Achenbach T, Edelbrock C (1983), Manual for the Child Behavior Checklist and Revised Child Behavior Profile. Burlington: University of Vermont, Department of Psychiatry
6. American Psychiatric Association (1994), Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), Washington, DC: American Psychiatric Association
7. Barkley RA (1988), The effects of methylphenidate on the interactions of preschool ADHD children with their mothers. J Am Acad Child Adolesc Psychiatry 27:336-341
8. Barkley RA, Karlsson J, Strzelecki E, Murphy JV (1984), Effects of age and Ritalin dosage on the mother-child interactions of hyperactive children. J Consult Clin Psychol 52:750-758
9. Berument SK, Rutter M, Lord C, Pickles A, Bailey A (1999), Autism Screening Questionnaire: diagnostic validity. Br J Psychiatry 175:444-451
10. Campbell SB (1987), Parent-referred problem three-year-olds: developmental changes in symptoms. J Child Psychol Psychiatry 28:835-845
11. Campbell SB, Ewing LJ (1990), Follow-up of hard-to-manage preschoolers: adjustment at age 9 and predictors of continuing symptoms. J Child Psychol Psychiatry 31:871-889
12. Cohen NJ (1981), Evaluation of the relative effectiveness of methylphenidate and cognitive behavior modification in the treatment of kindergarten-aged hyperactive children. J Abnormal Child Psychol 9:43-54
13. Conners CK (1975), Controlled trial of methylphenidate in preschool children with minimal brain dysfunction. Int J Ment Health 4:61-74
14. Conners CK (1997), Conners Rating Scales-Revised: Technical Manual. North Tonawanda, NY: Multi-Health Systems
15. Cunningham CE (2005), COPE: Large group, community based, family-centred parent training. In: Attention Deficit Hyperactivity: A Handbook for Diagnosis and Treatment, Barkley RA, ed. New York: The Guilford Press
16. Cunningham CE, Boyle M, Offord D et al. (2000), Tri-ministry study: correlates of school-based parenting course utilization. J Consult Clin Psychol 68:928-933
17. Cunningham CE, Bremner R, Boyle M (1995), Large group community-based parenting programs for families of preschoolers at risk for disruptive behaviour disorders: utilization, cost effectiveness, and outcome. J Child Psychol Psychiatry 36:1141-1159
18. Cunningham CE, Bremner R, Secord M (1998), COPE, The Community Parent Education Program: A School-Based Family Systems Oriented Workshop for Parents of Children With Disruptive Behavior Disorders. Hamilton, Canada: COPE Works
19. DeBar LL, Lynch F, Powell J, Gale J (2003), Use of psychotropic agents in preschool children: associated symptoms, diagnoses, and health care services in a health maintenance organization. Arch Pediatr Adolesc Med 157:150-157
20. DuPaul GJ, McGoey KE, Eckert TL, VanBrakle J (2001), Preschool children with attention-deficit/hyperactivity disorder: impairments in behavioral, social, and school functioning. J Am Acad Child Adolesc Psychiatry 40:508-515
21. Elliott CD (1990), Differential Abilities Scale. San Antonio, TX: The Psychological Corporation
22. Fan J, McCandliss BD, Sommer T, Raz A, Posner MI (2002), Testing the efficiency and independence of attentional networks. J Cogn Neurosci 14:340-347
23. Firestone P, Musten LM, Pisterman S, Mercer J, Bennett S (1998), Short-term side effects of stimulant medication are increased in preschool children with attention-deficit/hyperactivity disorder: a double-blind placebo-controlled study. J Child Adolesc Psychopharmacol 8:13-25
24. Gadow KD, Sprafkin J (1996), Child and Adolescent Symptom Inventories. Odessa, FL: Psychological Assessment Resources
25. Gittleman-Klein R, Klein DF (1976), Methylphenidate effects in learning disabilities. Psychometric changes. Arch Gen Psychiatry 33:655-664
26. Greenhill LL (1998), The use of psychotropic medication in preschoolers: indications, safety, and efficacy. Can J Psychiatry 43:576-581
27. Greenhill LL, Abikoff HB, Arnold LE et al. (1996), Medication treatment strategies in the MTA study: relevance to clinicians and researchers. J Am Acad Child Adolesc Psychiatry 35:1304-1313
28. Greenhill LL, Jensen PS, Abikoff H et al. (2003), Developing strategies for psychopharmacological studies in preschool children. J Am Acad Child Adolesc Psychiatry 42:406-414
29. 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 (2006), Efficacy and safety of immediate-release methylphenidate treatment for preschoolers with ADHD. J Am Acad Child Adolesc Psychiatry 45:1284-1293
30. Greenhill LL, Swanson JM, Vitiello B et al. (2001), Impairment and deportment responses to different methylphenidate doses in children with ADHD: the MTA titration trial. J Am Acad Child Adolesc Psychiatry 40:180-187
31. Gresham FM, Elliott SN (1989), Social Skills Rating System: Parent. Teacher and Child Forms. Circle Pines, MN: American Guidance Systems
32. Guy W (1976), ECDEU Assessment Manual for Psychopharmacology. (Revised). Washington, DC: U.S. Department of Health, Education and Welfare (DHEW)
33. Handen BL, Feldman HM, Lurier A, Murray PJ (1999), Efficacy of methylphenidate among preschool children with developmental disabilities and ADHD. J Am Acad Child Adolesc Psychiatry 38:805-812
34. IMS America (1995), National Disease and Therapeutic Index. Plymouth Meeting, PA: IMS
35. Kaufman G, Malone A, Asante K (1996), Attention deficit hyperactivity disorder in New York State: What can we learn from methylphenidate prescriptions? Paper presented at Stimulant Use in the Treatment of ADHD Conference, San Antonio, TX, December 10-12
36. Korkman M, Kemp SL, Kirk U (2001), Effects of age on neurocognitive measures of children ages 5 to 12: a cross-sectional study on 800 children from the United States. Dev Neuropsychol 20:331-354
37. Lahey BB, Pelham WE, Loney J et al. (2004), Three-year predictive validity of DSM-IV attention deficit hyperactivity disorder in children diagnosed at 4-6 years of age. Am J Psychiatry 161:2014-2020
38. Lahey BB, Pelham WE, Stein MA et al. (1998), Validity of DSM-IV attention-deficit/hyperactivity disorder for younger children. J Am Acad Child Adolesc Psychiatry 37:695-702
39. Lavigne JV, Gibbons RD, Christoffel KK et al. (1996), Prevalence rates and correlates of psychiatric disorders among preschool children. J Am Acad Child Adolesc Psychiatry 35:204-214
40. Leckman JF, Riddle MA, Hardin MT et al. (1989), The Yale Global Tic Severity Scale: initial testing of a clinician-rated scale of tic severity. J Am Acad Child Adolesc Psychiatry 28:566-573
41. Loney J, Milich R (1982), Hyperactivity, inattention, and aggression in clinical practice. In: Advances in Developmental and Behavioral Pediatrics, Vol 3, Wolraich M, Routh DK, eds. Greenwich, CT: JAI Press, pp 113-147
42. Mayes SD, Crites DL, Bixler EO, Humphrey FJ 2nd, Mattison RE (1994), Methylphenidate and ADHD: influence of age, IQ and neurodevelopmental status. Dev Med Child Neurol 36:1099-1107
43. Medco Health Solutions (2004), 2004 Drug Trend Report; http://www.medcohealth.com. Accessed May 17, 2004
44. MTA Cooperative Group (1999), A 14-month randomized clinical trial of treatment strategies for attention deficit hyperactivity disorder. Arch Gen Psychiatry 56:1073-1086
45. Musten LM, Firestone P, Pisterman S, Bennett S, Mercer J (1997), Effects of methylphenidate on preschool children with ADHD: cognitive and behavioral functions. J Am Acad Child Adolesc Psychiatry 36:1407-1415
46. Pierce EW, Ewing LJ, Campbell SB (1999), Diagnostic status and symptomatic behavior of hard-to-manage preschool children in middle childhood and early adolescence. J Clin Child Psychol 28:44-57
47. Rappley M, Gardiner J, Tetton J, Houang R (1995), The use of methylphenidate in Michigan. Arch Pediatr Adolesc Med 149:675-679
48. Schleifer M, Weiss G, Cohen N, Elman M, Cvejic H, Kruger E (1975), Hyperactivity in preschoolers and the effect of methylphenidate. Am J Orthopsychiatry 45:38-50
49. Shaffer D, Fisher P, Lucas CP, Dulcan MK, Schwab-Stone ME (2000), NIMH Diagnostic Interview Schedule for Children Version IV (NIMH DISC-IV): description, differences from previous versions, and reliability of some common diagnoses. J Am Acad Child Adolesc Psychiatry 39:28-38
50. Shaffer D, Gould MS, Brasic J et al. (1983), A Children's Global Assessment Scale (CGAS). Arch Gen Psychiatry 40:1228-1231
51. Short EJ, Manos MJ, Findling RL, Schubel EA (2004), A prospective study of stimulant response in preschool children: insights from ROC analyses. J Am Acad Child Adolesc Psychiatry 43:251-259
52. Simon HA (1975), The functional equivalence of problem solving skills. Cogn Psychol 7:268-288
53. Sonuga-Barke EJ, Daley D, Thompson M, Laver-Bradbury C, Weeks A (2001), Parent-based therapies for preschool attention-deficit/hyperactivity disorder: a randomized, controlled trial with a community sample. J Am Acad Child Adolesc Psychiatry 40:402-408
54. Sparrow SS, Balla DA, Cicchetti DV (1984), Vineland Adaptive Behavior Scales: Interview Edition, Survey Form Manual. Circle Pines, MN: American Guidance Service
55. Swanson JM (1992), School-Based Assessments and Interventions for ADD Students. Irvine, CA: K.C. Publications
56. 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 (2006), Stimulant-related reductions of growth rates in the PATS. J Am Acad Child Adolesc Psychiatry 45:1304-1313
57. Swanson JM, Kraemer HC, Hinshaw SP et al. (2001), Clinical relevance of the primary findings of the MTA: success rates based on severity of ADHD and ODD symptoms at the end of treatment. J Am Acad Child Adolesc Psychiatry 40:168-179
58. Swanson J, Wigal S, Greenhill L et al. (1998), Objective and subjective measures of the pharmacodynamic effects of Adderall in the treatment of children with ADHD in a controlled laboratory classroom setting. Psychopharmacol Bull 34:55-60
59. U.S. Food and Drug Administration (1997), Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. Fed Reg 62:43899-43916
60. Vitiello B (2001), Long-term effects of stimulant medications on the brain: possible relevance to the treatment of attention deficit hyperactivity disorder. J Child Adolesc Psychopharmacol 11:25-34
61. Wells KC, Pelham WE, Kotkin RA et al. (2000), Psychosocial treatment strategies in the MTA study: rationale, methods, and critical issues in design and implementation. J Abnorm Child Psychol 28:483-505
62. 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 (2006), Safety and tolerability of methylphenidate in preschool children with ADHD. J Am Acad Child Adolesc Psychiatry 45:1294-1303
63. Wigal SB, Gupta S, Guinta D, Swanson JM (1998), Reliability and validity of the SKAMP rating scale in a laboratory school setting. Psychopharmacol Bull 34:47-53
64. Wilens TE, Biederman J, Brown S, Monuteaux M, Prince J, Spencer TJ (2002), Patterns of psychopathology and dysfunction in clinically referred preschoolers. J Dev Behav Pediatr 23:S31-S36
65. Zito JM, Safer DJ, dosReis S, Gardner JF, Boles M, Lynch F (2000), Trends in the prescribing of psychotropic medications to preschoolers. JAMA 283:1025-1030