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Child and Adolescent Psychiatry and Mental Health
Published in: Child and Adolescent Psychiatry and Mental Health 1/2009

Open Access 01-12-2009 | Research

The Pediatric Obsessive-Compulsive Disorder Treatment Study II: rationale, design and methods

Authors: Jennifer B Freeman, Molly L Choate-Summers, Abbe M Garcia, Phoebe S Moore, Jeffrey J Sapyta, Muniya S Khanna, John S March, Edna B Foa, Martin E Franklin

Published in: Child and Adolescent Psychiatry and Mental Health | Issue 1/2009

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Abstract

Abstract

This paper presents the rationale, design, and methods of the Pediatric Obsessive-Compulsive Disorder Treatment Study II (POTS II), which investigates two different cognitive-behavior therapy (CBT) augmentation approaches in children and adolescents who have experienced a partial response to pharmacotherapy with a serotonin reuptake inhibitor for OCD. The two CBT approaches test a "single doctor" versus "dual doctor" model of service delivery. A specific goal was to develop and test an easily disseminated protocol whereby child psychiatrists would provide instructions in core CBT procedures recommended for pediatric OCD (e.g., hierarchy development, in vivo exposure homework) during routine medical management of OCD (I-CBT). The conventional "dual doctor" CBT protocol consists of 14 visits over 12 weeks involving: (1) psychoeducation, (2), cognitive training, (3) mapping OCD, and (4) exposure with response prevention (EX/RP). I-CBT is a 7-session version of CBT that does not include imaginal exposure or therapist-assisted EX/RP. In this study, we compared 12 weeks of medication management (MM) provided by a study psychiatrist (MM only) with two types of CBT augmentation: (1) the dual doctor model (MM+CBT); and (2) the single doctor model (MM+I-CBT). The design balanced elements of an efficacy study (e.g., random assignment, independent ratings) with effectiveness research aims (e.g., differences in specific SRI medications, dosages, treatment providers). The study is wrapping up recruitment of 140 youth ages 7–17 with a primary diagnosis of OCD. Independent evaluators (IEs) rated participants at weeks 0,4,8, and 12 during acute treatment and at 3,6, and 12 month follow-up visits.

Trial registration

NCT00074815
Appendix
Available only for authorised users
Literature
1.
Franklin M, Foa E, March JS: The Pediatric Obsessive-Compulsive Disorder Treatment Study: Rationale, design, and methods. Journal of Child and Adolescent Psychopharmacology. 2003, 13: S39-S51. 10.1089/104454603322126331.CrossRefPubMed
2.
Pediatric OCD Treatment Study Team [POTS]: Cognitive-behavior therapy, sertraline, and their combination with children and adolescents with Obsessive-Compulsive Disorder: The Pediatric OCD Treatment Study (POTS) randomized controlled trial. JAMA. 2004, 292: 1969-1976. 10.1001/jama.292.16.1969.CrossRef
3.
King RA, Leonard HL, March J: Practice parameters for the assessment and treatment of children and adolescents with obsessive-compulsive disorder. Journal of the American Academy of Child and Adolescent Psychiatry. 1998, 37: 27S-45S. 10.1097/00004583-199804000-00017.CrossRef
4.
March JS, Frances A, Carpenter D, Kahn DA, Foa EB, Greist JH, Liebowitz MR, Campeas RB, Ainsworth TL, Broatch J: Treatment of obsessive-compulsive disorder. Journal of Clinical Psychiatry. 1997, 58: 2-72.
5.
Cartwright C, Hollander E: SSRIs in the treatment of obsessive-compulsive disorder. Depression and Anxiety. 1998, 8: 105-113. 10.1002/(SICI)1520-6394(1998)8:1+<105::AID-DA16>3.0.CO;2-T.CrossRefPubMed
6.
Rushton JL, Whitmore JT: Pediatric stimulant and selective serotonin reuptake inhibitor prescription trends: 1992 to 1998. Archives of Pediatrics and Adolescent Medicine. 2001, 155: 560-565.CrossRefPubMed
7.
Flament MF, Whitaker A, Rapoport JL, Davies M, Berg CZ, Kalikow K, Sceery W, Shaffer D: Obsessive compulsive disorder in adolescence: An epidemiological study. Journal of the American Academy of Child and Adolescent Psychiatry. 1988, 27: 764-771. 10.1097/00004583-198811000-00018.CrossRefPubMed
8.
Mullick M, Goodman R: The prevalence of psychiatric disorders in 5–10 year olds in rural, urban and slum areas in Bangladesh. Social Psychiatry and Psychiatric Epidemiology. 2005, 40: 663-671. 10.1007/s00127-005-0939-5.CrossRefPubMed
9.
Valleni-Basile LA, Garrison CZ, Jackson KL, Waller JL, McKeown RE, Addy CL, Cuffe SP: Frequency of obsessive-compulsive disorder in a community sample of young adolescents. Journal of the American Academy of Child and Adolescent Psychiatry. 1995, 34: 128-129. 10.1097/00004583-199502000-00006.CrossRefPubMed
10.
Rasmussen SA, Eisen J: The epidemiology and differential diagnosis of obsessive compulsive disorder. Journal of Clinical Psychiatry. 1992, 53: 4-10.PubMed
11.
Flament MF, Koby E, Rapoport JL, Berg CJ, Zahn T, Cox C, Denckla M, Lenane M: Childhood obsessive-compulsive disorder: A prospective follow-up study. Journal of Child Psychology and Psychiatry. 1990, 31: 363-380. 10.1111/j.1469-7610.1990.tb01575.x.CrossRefPubMed
12.
Leonard HL, Lenane M, Swedo SE: Obsessive-compulsive disorder. Child and Adolescent Psychiatric Clinics of North America. 1993, 2: 655-665.
13.
Swedo SE, Rapoport JL, Leonard HL, Lenane M, Cheslow D: Obsessive compulsive disorders in children and adolescents: Clinical phenomenology of 70 consecutive cases. Archives of General Psychiatry. 1989, 46: 335-343.CrossRefPubMed
14.
Piacentini J, Bergman RL, Keller M, McCracken J: Functional impairment in children and adolescents with obsessive-compulsive disorder. Journal of Child and Adolescent Psychopharmacology. 2003, 13: S61-S69. 10.1089/104454603322126359.CrossRefPubMed
15.
March JS, Biederman J, Wolkow R, Safferman A, Mardekian J, Cook EH, Cutler NR, Dominguez R, Ferguson J, Muller B: Sertraline in children and adolescents with obsessive-compulsive disorder: A multicenter randomized controlled trial. Journal of the American Medical Association. 1998, 280: 1752-1756. 10.1001/jama.280.20.1752.CrossRefPubMed
16.
Abramowitz JS, Whiteside SP, Deacon BJ: The effectiveness of treatment for pediatric obsessive-compulsive disorder: a meta-analysis. Behavior Therapy. 2005, 36: 55-63. 10.1016/S0005-7894(05)80054-1.CrossRef
17.
Franklin ME, Kozak MJ, Cashman LA, Coles ME, Rheingold AA, Foa EB: Cognitive-behavioral treatment of pediatric obsessive-compulsive disorder: an open clinical trial. Journal of the American Academy of Child and Adolescent Psychiatry. 1998, 37: 412-419. 10.1097/00004583-199804000-00019.CrossRefPubMed
18.
March J, Mulle K, Herbel B: Behavioral psychotherapy for children and adolescents with obsessive-compulsive disorder: An open trial of a new protocol-driven treatment package. Journal of the American Academy of Child and Adolescent Psychiatry. 1994, 33: 333-341. 10.1097/00004583-199403000-00006.CrossRefPubMed
19.
Piacentini J, Bergman L, Jacobs C, McCracken JT, Kretchman J: Open trial of cognitive behavior therapy for childhood obsessive-compulsive disorder. Journal of Anxiety Disorders. 2002, 16: 207-219. 10.1016/S0887-6185(02)00096-8.CrossRefPubMed
20.
Wever C, Rey JM: Juvenile obsessive-compulsive disorder. Australian and New Zealand Journal of Psychiatry. 1997, 31: 105-113. 10.3109/00048679709073806.CrossRefPubMed
21.
de Haan E, Hoogduin KA, Buitelaar JK, Keijsers GP: Behavior therapy versus clomipramine for the treatment of obsessive-compulsive disorder in children and adolescents. Journal of the American Academy of Child and Adolescent Psychiatry. 1998, 37: 1022-1029.CrossRefPubMed
22.
Barrett P, Healy-Farrell L, March JS: Cognitive-behavioral family treatment of childhood obsessive-compulsive disorder: a controlled trial. Journal of the American Academy of Child and Adolescent Psychiatry. 2004, 43: 46-62. 10.1097/00004583-200401000-00014.CrossRefPubMed
23.
Storch E, Geffken G, Merlo L: Family-based cognitive-behavioral therapy for pediatric obsessive-compulsive disorder: Comparison of intensive and weekly approaches. Journal of the American Academy of Child and Adolescent Psychiatry. 2007, 46: 469-478. 10.1097/chi.0b013e31803062e7.CrossRefPubMed
24.
Asbahr FR, Garvey MA, Snider LA, Zanetta DM, Elkis H, Swedo SE: Obsessive-compulsive symptoms among patients with Sydenham chorea. Biological Psychiatry. 2005, 57: 1073-1076. 10.1016/j.biopsych.2005.01.037.CrossRefPubMed
25.
Abramowitz J, Foa E, Franklin M: Exposure and ritual prevention for obsessive-compulsive disorder: Effects of intensive versus twice-weekly sessions. Journal of Consulting and Clinical Psychology. 2003, 71: 394-398. 10.1037/0022-006X.71.2.394.CrossRefPubMed
26.
Barrett P, Farrell L, Dadds M, Boulter N: Cognitive-behavioral family treatment of childhood obsessive-compuslive disorder: Long-term follow-up and predictors of outcome. Journal of the American Academy of Child and Adolescent Psychiatry. 2005, 44: 1005-1014. 10.1097/01.chi.0000172555.26349.94.CrossRefPubMed
27.
Freeman JB, Choate-Summers ML, Moore PS, Garcia AM, Sapyta JJ, Leonard HL, Franklin ME: Cognitive behavioral treatment for young children with obsessive-compulsive disorder. Biological Psychiatry. 2007, 61: 337-343. 10.1016/j.biopsych.2006.12.015.PubMedCentralCrossRefPubMed
28.
Turner CM: Cognitive-behavioural theory and therapy for obsessive-compulsive disorder in children and adolescents: Current status and future directions. Clinical Psychology Review. 2006, 26: 912-938. 10.1016/j.cpr.2005.10.004.CrossRefPubMed
29.
Scahill L, Riddle MA, McSwiggan-Hardin M, Ort SI, King RA, Goodman WK, Cicchetti D, Leckman JF: Children's Yale-Brown Obsessive-Compulsive Scale: Reliability and validity. Journal of the American Academy of Child and Adolescent Psychiatry. 1997, 36: 844-852. 10.1097/00004583-199706000-00023.CrossRefPubMed
30.
Bloch M, Landeros-Weisenberger A, Kelmendi B, Coric V, Bracken M, Leckman J: A systematic review: Antipsychotic augmentation with treatment refractory obsessive compulsive disorder. Molecular Psychiatry. 2006, 11: 622-632. 10.1038/sj.mp.4001823.CrossRefPubMed
31.
Simpson HB, Foa E, Liebowitz MR, Ledley DR, Huppert JD, Cahill S, Vermes D, Schmidt AB, Hembree E, Franklin M: A randomized controlled trial of cognitive-behavioral therapy for augmenting pharmacotherapy in obsessive-compulsive disorder. American Journal of Psychiatry. 165 (5): 621-30. 10.1176/appi.ajp.2007.07091440.
32.
Armbruster P, Sukhodolsky D, Michalsen R: The impact of managed care on children's outpatient treatment: A comparison study of treatment outcomes before and after managed care. American Journal of Orthopsychiatry. 2004, 74: 5-13. 10.1037/0002-9432.74.1.5.CrossRefPubMed
33.
Whitaker A, Johnson J, Shaffer D, Rapoport J, Kalikow K, Walsh B, Davies M, Braiman S, Dolinsky A: Uncommon troubles in young people: Prevalence estimates of selected psychiatric disorders in a nonreferred adolescent population. Archives of General Psychiatry. 1990, 47: 487-496.CrossRefPubMed
34.
Taylor CB, Chang VY: Issues in the dissemination of cognitive-behavior therapy. Nordic Journal of Psychiatry. 2008, 62: 37-44. 10.1080/08039480802315673.CrossRefPubMed
35.
Wang PS, Demier O, Kessler RC: Adequacy of treatment for serious mental illness in the United States. American Journal of Public Health. 2002, 92: 92-98. 10.2105/AJPH.92.1.92.PubMedCentralCrossRefPubMed
36.
Valderhaug R, Larsson B, Gotestam K, Piacentini J: An open clinical trial of cognitive-behaviour therapy in children and adolescents with obsessive-compulsive disorder administered in regular outpatient clinics. Behaviour Research and Therapy. 2007, 45: 577-589. 10.1016/j.brat.2006.04.011.CrossRefPubMed
37.
McDougle CJ, Epperson CN, Pelton GH, Wasylink S, Price LH: A double-blind, placebo-controlled study of risperidone addition in serotonin reuptake inhibitor-refractory obsessive-compulsive disorder. Archives General Psychiatry. 2000, 57: 794-801. 10.1001/archpsyc.57.8.794.CrossRef
38.
Greenhouse J, Stangl D, Kupfer D, Prien R: Methodologic issues in maintenance therapy clinical trials. Archives of General Psychiatry. 1991, 48: 313-318.CrossRefPubMed
39.
Silverman WK, Albano AM: Anxiety Disorders Interview Schedule for DSM-IV. 1996, San Antonio: The Psychological Corporation
40.
Riddle MA, Scahill L, King RA, Hardin MT, Anderson GM, Ort SI, Smith JC, Leckman JF, Cohen DJ: Double-blind, crossover trial of fluoxetine and placebo in children and adolescents with obsessive-compulsive disorder. Journal of the American Academy of Child and Adolescent Psychiatry. 1992, 31: 1062-1069.CrossRefPubMed
41.
Liebowitz MR, Turner S, Piacentini J, Beidel D, Clarvit SR, Davies SO, Graae F, Jaffer M, Lin SH, Sallee FR: Fluoxetine in children and adolescents with OCD: a placebo-controlled trial. Journal of the American Academy of Child and Adolescent Psychiatry. 2002, 41: 1431-1438. 10.1097/00004583-200212000-00014.CrossRefPubMed
42.
Riddle MA, Reeve EA, Yaryura-Tobias JA, Yang HM, Claghorn JL, Gaffney G, Greist JH, Holland D, McConville BJ, Pigott T, Walkup JT: Fluvoxamine for children and adolescents with obsessive-compulsive disorder: A randomized, controlled, multicenter trial. Journal of the American Academy of Child and Adolescent Psychiatry. 2001, 40: 222-229. 10.1097/00004583-200102000-00017.CrossRefPubMed
43.
Rosenberg DR, Stewart CM, Fitzgerald KD, Tawile V, Carroll E: Paroxetine open-label treatment of pediatric outpatients with obsessive-compulsive disorder. Journal of the American Academy of Child and Adolescent Psychiatry. 1999, 38: 1180-1185. 10.1097/00004583-199909000-00024.CrossRefPubMed
44.
DeVeaugh-Geiss J, Moroz G, Biederman J, Cantwell DP, Fontaine R, Greist JH, Reichler R, Katz R, Landau P: Clomipramine hydrochloride in childhood and adolescent obsessive-compulsive disorder – a multicenter trial. Journal of the American Academy of Child and Adolescent Psychiatry. 1992, 31: 45-49. 10.1097/00004583-199201000-00008.CrossRefPubMed
45.
Leonard HL, Swedo SE, Rapoport JL, Koby EV, Lenane MC, Cheslow DL, Hamburger SD: Treatment of obsessive-compulsive disorder with clomipramine and desipramine in children and adolescents. Archives General Psychiatry. 1989, 46: 1088-1092.CrossRef
46.
Hollander E, Allen A, Steiner M, Wheadon DE, Oakes R, Burnham DB: Acute and long-term treatment and prevention of relapse of obsessive-compulsive disorder with paroxetine. Journal of Clinical Psychiatry. 2003, 64: 1113-1121.CrossRefPubMed
47.
Goodman WK, Price LH, Rasmussen SA, Mazure C, Delgado P, Heninger GR, Charney DS: Yale-Brown obsessive compulsive scale. I. Development, use, and reliability. Archives of General Psychiatry. 1989, 46: 1007-1016.
48.
Goodman WK, Price LH, Rasmussen SA, Mazure C, Delgado P, Heninger GR, Charney DS: Yale-Brown Obsessive-Compulsive Scale. II. Validity. Archives of General Psychiatry. 1989, 46: 1012-1016.CrossRefPubMed
49.
Haug TT, Hellstrom K, Blomhoff S, Humble M, Madsbu H-P, Wold JE: The treatment of social phobia in general practice: Is exposure therapy feasible?. Family Practice. 2000, 17: 114-118. 10.1093/fampra/17.2.114.CrossRefPubMed
50.
March J, Mulle K: "How I ran OCD off my land": A clinician's guide to cognitive-behavioral psychotherapy for pediatric obsessive-compulsive disorder. Durham, NC: Duke University Medical Center, 49.
51.
May DE, Kratochvil CJ, Hallin MJ, Reinecke MA, Vitiello B, Weller EB, Pathak S, Simons AD, March JS: A manual-based intervention to address clinical crises and retain patients in the Treatment of Adolescents With Depression Study (TADS). Journal of the American Academy of Child and Adolescent Psychiatry. 2007, 46: 573-581. 10.1097/chi.0b013e3180323342.CrossRefPubMed
52.
Abikoff , Arnold , Newcom , Elliott , Hechtman , Severe , Wigal , Shapiro , Cantwell , Conners : Emergency/Adjunct services and attrition prevention for randomized clinical trials in children: The MTA manual-based solution. Journal of the American Academy of Child and Adolescent Psychiatry. 2002, 41: 498-504. 10.1097/00004583-200205000-00006.CrossRefPubMed
53.
54.
Gibbons RD, Hedeker D, Elkin I, Waternaux C, Kraemer HC, Greenhouse JB, Shea MT, Imber SD, Sotsky SM, Watkins JT: Some conceptual and statistical issues in analysis of longitudinal psychiatric data. Archives of General Psychiatry. 1993, 50: 739-750.CrossRefPubMed
55.
Zeger S, Diggle P: Semiparametric models for longitudinal data with application to CD4 cell numbers in HIV seroconverters. Biometrics. 1994, 50: 689-699. 10.2307/2532783.CrossRefPubMed
56.
Lavori PW, Dawson R, Mueller TB: Causal estimation of time-varying treatment effects in observational studies: Application to depressive disorder. Statistics in medicine. 1994, 13: 1089-1100. 10.1002/sim.4780131102.CrossRefPubMed
57.
Holmbeck GN: Toward terminological, conceptual, and statistical clarity in the study of mediators and moderators: Examples from the child-clinical and pediatric psychology literatures. Journal of Consulting and Clinical Psychology. 1997, 65: 599-610. 10.1037/0022-006X.65.4.599.CrossRefPubMed
58.
March JS, Curry JF: Predicting the outcome of treatment. Journal of Abnormal Child Psychology. 1998, 26: 39-51. 10.1023/A:1022682723027.CrossRefPubMed
59.
Kraemer HC, Wilson GT, Fairburn CG, Agras WS: Mediators and moderators of treatment effects in randomized clinical trials. Archives of General Psychiatry. 2002, 59: 877-883. 10.1001/archpsyc.59.10.877.CrossRefPubMed
60.
Pinson L, Gray G: Number needed to treat: An underused measure of treatment effect. Psychiatric Services. 2003, 54: 145-146. 10.1176/appi.ps.54.2.145.CrossRefPubMed
61.
Zito J, Tobi H, de Jong-van den Berg L, Fegert J, Safer D, Janhsen K, Hansen D, Gardner J, Glaeske G: Antidepressant prevalence for youths: A multi-national comparison. Pharmacoepidemiology and Drug Safety. 2006, 15: 793-798. 10.1002/pds.1254.CrossRefPubMed
62.
Vitiello B: An international perspective on pediatric psychopharmacology. International Review of Psychiatry. 2008, 20: 121-126. 10.1080/09540260801887710.CrossRefPubMed
Metadata
Title
The Pediatric Obsessive-Compulsive Disorder Treatment Study II: rationale, design and methods
Authors
Jennifer B Freeman
Molly L Choate-Summers
Abbe M Garcia
Phoebe S Moore
Jeffrey J Sapyta
Muniya S Khanna
John S March
Edna B Foa
Martin E Franklin
Publication date
01-12-2009
Publisher
BioMed Central
Published in
Child and Adolescent Psychiatry and Mental Health / Issue 1/2009
Electronic ISSN: 1753-2000
DOI
https://doi.org/10.1186/1753-2000-3-4

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