Defining, identifying, and evaluating clinical trials of stuttering treatments: A tutorial for clinicians

American Journal of Speech-Language Pathology

Volumn 17, Issue 4, 2008, Pages 401-415

  Onslow, Mark ^a   Jones, Mark ^b   O'Brian, Sue ^a   Menzies, Ross ^a   Packman, Ann ^a  

^a UNIVERSITY OF SYDNEY   (Australia)

^b UNIVERSITY OF QUEENSLAND   (Australia)

Author keywords

Adults; Children; Clinical trials; Efficacy; Stuttering severity

Indexed keywords

EID: 55249090456     PISSN: 10580360     EISSN: 15589110     Source Type: Journal    
DOI: 10.1044/1058-0360(2008/07-0047)     Document Type: Review

References (115)

1. Ambrose, N. G., & Yairi, E. (1999). Normative disfluency data for early childhood stuttering. Journal of Speech, Language, and Hearing Research, 42, 895-909.
2. Andrews, G., & Feyer, A. M. (1985). Does behavior therapy still work when the experimenters depart? An analysis of a behavioral treatment program for stuttering. Behavior Modification, 9, 443-457.
3. Andrews, G., Guitar, B., & Howie, P. (1980). Meta-analysis of the effects of stuttering treatment. Journal of Speech and Hearing Disorders, 45, 287-307.
4. Barnett, A. G., van der Pols, J. C., & Dobson, A. J. (2005). Regression to the mean: What it is and how to deal with it. International Journal of Epidemiology, 34, 215-220.
5. Block, S., Onslow, M., Packman, A., & Dacakis, G. (2006). Connecting stuttering management and measurement: IV. Predictors of outcome for a behavioural treatment for stuttering. International Journal of Language and Communication Disorders, 41, 395-406.
6. Block, S., Onslow, M., Packman, A., Gray, B., & Dacakis, G. (2005). Treatment of chronic stuttering: Outcomes from a student training clinic. International Journal of Language and Communication Disorders, 40, 455-466.
7. Block, S., Onslow, M., Roberts, R., & White, S. (2004). Control of stuttering with EMG feedback. Advances in Speech Language Pathology, 6(2), 100-106.
8. Blomgren, M., Roy, N., Callister, T., & Merrill, R. M. (2005). Intensive stuttering modification therapy: A multidimensional assessment of treatment outcomes. Journal of Speech, Language, and Hearing Research, 48, 509-523.
9. Bloodstein, O. (1995). A handbook on stuttering (5th ed.). San Diego, CA: Singular.
10. Boberg, E. (1981). Maintenance of fluency: An experimental program. In E. Boberg (Ed.), Maintenance of fluency (pp. 71-111). New York: Elsevier.
11. Boberg, E., & Kully, D. (1994). Long-term results of an intensive treatment program for adults and adolescents who stutter. Journal of Speech and Hearing Research, 37, 1050-1059.
12. Bothe, A. K., Davidow, J. H., Bramlett, R. E., Franic, D. M., & Ingham, R. J. (2006). Stuttering treatment research 1970-2005: II. Systematic review incorporating trial quality assessment of pharmacological approaches. American Journal of Speech-Language Pathology, 15, 342-352.
13. Bothe, A. K., Davidow, J. H., Bramlett, R. E., & Ingham, R. J. (2006). Stuttering treatment research 1970-2005: I. Systematic review incorporating trial quality assessment of behavioral, cognitive, and related approaches. American Journal of Speech-Language Pathology, 15, 321-341.
14. Brundage, S. B., Bothe, A. K., Lengeling, A. N., & Evans, J. J. (2006). Comparing judgments of stuttering made by students, clinicians, and highly experienced judges. Journal of Fluency Disorders, 31, 271-283.
15. The CONSORT Group. (2008). CONSORT statement. Retrieved January 15, 2008, from www.consort-statement.org/?o=1001.
16. Conture, E. G., & Guitar, B. E. (1993). Evaluating efficacy of treatment of stuttering - school-age children. Journal of Fluency Disorders, 18, 253-287.
17. Costello, J. (1979). Clinicians and researchers: A necessary dichotomy? Journal of the National Student Speech and Hearing Association, 7, 6-26.
18. Craig, A. R., & Hancock, K. (1995). Self-reported factors related to relapse following treatment for stuttering. Australian Journal of Human Communication Disorders, 23, 48-60.
19. Craig, A., Hancock, K., Chang, E., McCready, C., Shepley, A., McCaul, A., et al. (1996). A controlled clinical trial for stuttering in persons aged 9 to 14 years. Journal of Speech and Hearing Research, 39, 808-826.
20. Curlee, R. F. (1993). Evaluating treatment efficacy for adults - assessment of stuttering disability. Journal of Fluency Disorders, 18, 319-331.
21. Curlee, R., & Yairi, E. (1998). Treatment of early childhood stuttering: Advances and research needs. American Journal of Speech-Language Pathology, 7(3), 20-26.
22. Davidow, J. H., Bothe, A. K., & Bramlett, R. E. (2006). The stuttering treatment research evaluation and assessment tool (STREAT): Evaluating treatment research as part of evidence-based practice. American Journal of Speech-Language Pathology, 15, 126-141.
23. De Angelis, C., Drazen, J. M., Frizelle, F. A., Haug, C. H., Hoey, J., Horton, R., et al. (2007). Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. Retrieved January 15, 2008, from www.icmje.org/clin_trialup.htm.
24. De Klinder, M., & Boelens, H. (1998). Habit-reversal treatment for children's stuttering - assessment in three settings. Journal of Behavior Therapy and Experimental Psychiatry, 29, 261-265.
25. Franken, M. C. J., Kielstra-Van der Schalka, C. J., & Boelens, H. (2005). Experimental treatment of early stuttering: A preliminary study. Journal of Fluency Disorders, 30, 189-199.
26. Hancock, K., Craig, A., McCready, C., McCaul, A., Costello, D., Gilmore, G., et al. (1998). Two- to six-year controlled-trial stuttering outcomes for children and adolescents. Journal of Speech, Language, and Hearing Research, 41, 1242-1252.
27. Harris, V., Onslow, M., Packman, A., Harrison, E., & Menzies, R. (2002). An experimental investigation of the impact of the Lidcombe Program on early stuttering. Journal of Fluency Disorders, 27, 203-214.
28. Harrison, E., Onslow, M., Andrews, C., Packman, A., & Webber, M. (1998). Control of stuttering with prolonged speech: Development of a one-day instatement program. In A. K. Cordes & R. J. E. Ingham (Eds.), Treatment efficacy in stuttering (pp. 191-212). San Diego, CA: Singular.
29. Harrison, E., Wilson, L., & Onslow, M. (1999). Distance intervention for early stuttering with the Lidcombe Programme. Advances in Speech Language Pathology, 1, 31-36.
30. Hearne, A., Packman, A., Onslow, M., & O'Brian, S. (2008). Developing treatments for adolescents who stutter: A Phase I trial of the Camperdown Program. Language, Speech, and Hearing Services in Schools, 39, 487-497.
31. Hegde, M. N. (2007). A methodological review of randomized clinical trials. Communicative Disorders Review, 1, 15-36.
32. Herson, J. (1984). Monitoring data logistics with a PC. Controlled Clinical Trials, 5, 308.
33. Hewat, S., O'Brian, S., Onslow, M., & Packman, A. (2001). Control of chronic stuttering with self-imposed time-out: Preliminary outcome data. Papers from the 2nd Asia Pacific Conference on Speech, Language and Hearing, Part IV. Asia Pacific Journal of Speech, Language & Hearing, 6(2), 97-102.
34. Hewat, S., Onslow, M., Packman, A., & O'Brian, S. (2006). A Phase II clinical trial of self-imposed time-out treatment for stuttering in adults and adolescents. Disability and Rehabilitation, 28(1), 33-42.
35. Howie, P. M., Tanner, S., & Andrews, G. (1981). Short-term and long-term outcome in an intensive treatment program for adult stutterers. Journal of Speech and Hearing Disorders, 46, 104-109.
36. Huber, A., O'Brian, S., Onslow, M., & Packman, A. (2003). Results of a pilot study of EMG biofeedback for the control of stuttering in adolescents. In C. Williams & S. Leitao (Eds.), Nature, nurture, knowledge: Proceedings of the 2003 Speech Pathology Australia national conference (pp. 177-182). Melbourne, Australia: Speech Pathology Australia.
37. Ingham, J. C., & Riley, G. (1998). Guidelines for documentation of treatment efficacy for young children who stutter. Journal of Speech, Language, and Hearing Research, 41, 753-770.
38. Ingham, R. J. (1980). Modification of maintenance and generalization during stuttering treatment. Journal of Speech and Hearing Research, 23, 732-745.
39. Ingham, R. J. (1984). Stuttering and behavior therapy: Current status and experimental foundations. San Diego, CA: College Hill Press.
40. Ingham, R., & Andrews, G. (1973). An analysis of a token economy in stuttering therapy. Journal of Applied Behavior Analysis, 6, 219-229.
41. Ingham, R. J., Kilgo, M., Ingham, J. C., Moglia, R., Belknap, H., & Sanchez, T. (2001). Evaluation of a stuttering treatment based on reduction of short phonation intervals. Journal of Speech, Language, and Hearing Research, 44, 1229-1244.
42. James, J. E. (1981). Behavioral self-control of stuttering using time-out from speaking. Journal of Applied Behavior Analysis, 14, 25-37.
43. James, J. E., Ricciardelli, L. A., Hunter, C. E., & Rogers, P. (1989). Relative efficacy of intensive and spaced behavioral treatment of stuttering. Behavior Modification, 13, 376-395.
44. Jones, M., Gebski, V., Onslow, M., & Packman, A. (2002). Statistical power in stuttering research: A tutorial. Journal of Speech, Language, and Hearing Research, 45, 243-255.
45. Jones, M., Hearne, A., Onslow, M., Ormond, T., Williams, S., Schwarz, I., & O'Brian, S. (2008). Extended follow up of a randomised controlled trial of the Lidcombe Program of Early Stuttering Intervention. International Journal of Language and Communication Disorders, 7, 1-13.
46. Jones, M., Onslow, M., Harrison, E., & Packman, A. (2000). Treating stuttering in young children: Predicting treatment time in the Lidcombe Program. Journal of Speech, Language, and Hearing Research, 43, 1440-1450.
47. Jones, M., Onslow, M., Packman, A., Williams, S., Ormond, T., Schwarz, I., et al. (2005). Randomised controlled trial of the Lidcombe programme of early stuttering intervention. British Medical Journal, 331(7518), 659-661.
48. Kendall, P. C. (1981). Assessing generalization and the single-subject strategies. Behavior Modification, 5, 307-319.
49. Kingston, M., Huber, A., Onslow, M., Jones, M., & Packman, A. (2003). Predicting treatment time with the Lidcombe Program: Replication and meta-analysis. International Journal of Language and Communication Disorders, 38, 165-177.
50. Koushik, S., Shenker, R., Onslow, M., & Adaman, B. (2008). Follow-up of school-age children after Lidcombe Program treatment. Manuscript in preparation.
51. Kully, D., & Boberg, E. (1988). An investigation of interclinic agreement in the identification of fluent and stuttered syllables. Journal of Fluency Disorders, 13, 309-318.
52. Kully, D., & Boberg, E. (1991). Therapy for school-age children. Seminars in Speech and Language, 12, 291-300.
53. Kunz, R., & Oxman, A. D. (1998). The unpredictability paradox: Review of empirical comparisons of randomised and non-randomised clinical trials. British Medical Journal, 317(7167), 1185-1190.
54. Langevin, M., & Boberg, E. (1993). Results of an intensive stuttering therapy program. Journal of Speech-Language Pathology and Audiology, 17, 158-166.
55. Langevin, M., Huinck, W. J., Kully, D., Peters, H. F., Lomheim, H., & Tellers, M. (2006). A cross-cultural, long-term outcome evaluation of the ISTAR Comprehensive Stuttering Program across Dutch and Canadian adults who stutter. Journal of Fluency Disorders, 31, 229-256.
56. Lattermann, C., Euler, H. A., & Neumann, K. A. (2008). Randomized control trial to investigate the impact of the Lidcombe Program on early stuttering in German-speaking preschoolers. Journal of Fluency Disorders, 33, 52-65.
57. Lewis, C., Onslow, M., Packman, A., Jones, M., & Simpson, J. A. (2008). Phase II trial of telehealth delivery of the Lidcombe Program of early stuttering intervention. American Journal of Speech-Language Pathology, 17, 139-149.
58. Lincoln, M., & Onslow, M. (1997). Long-term outcome of an early intervention for stuttering. American Journal of Speech-Language Pathology, 6, 51-58.
59. Lincoln, M., Onslow, M., Lewis, C., & Wilson, L. (1996). A clinical trial of an operant treatment for school-age children who stutter. American Journal of Speech-Language Pathology, 5(2), 73-85.
60. Lipsey, M. W., & Wilson, D. B. (1993). The efficacy of psychological, educational, and behavioral treatment: Confirmation from meta-analysis. American Psychologist, 48, 1181-1209.
61. Martin, R. (1981). Introduction and perspective: Review of published research. In E. Boberg (Ed.), Maintenance of fluency (pp. 1-30). New York: Elsevier.
62. Martin, R. R., Kuhl, P., & Haroldson, S. (1972). An experimental treatment with two preschool stuttering children. Journal of Speech and Hearing Research, 15, 743-752.
63. McCrory, D. C., & Gray, R. N. (2004). Oral sumatriptan for acute migraine (Cochrane Review). Chichester, United Kingdom: Wiley.
64. McReynolds, L., & Thompson, C. (1986). Flexibility of single-subject experimental designs. Part I: Review of the basics of single-subject designs. Journal of Speech and Hearing Disorders, 51, 194-203.
65. Menzies, R., O'Brian, S., Onslow, M., Packman, A., St Clare, T., & Block, S. (in press). An experimental clinical trial of a cognitive behavior therapy package for chronic stuttering. Journal of Speech, Language, and Hearing Research.
66. Millard, S. K., Nicholas, A., & Cook, F. M. (2008). Is parent-child interaction therapy effective in reducing stuttering? Journal of Speech, Language, and Hearing Research, 51, 636-650.
67. Miller, B., & Guitar, B. (2006, November). Long term outcome of the Lidcombe Programof early stuttering intervention. Poster presented at the annual convention of the American Speech-Language-Hearing Association, Miami.
68. O'Brian, S., Onslow, M., Cream, A., & Packman, A. (2003). The Camperdown Program: Outcomes of a new prolonged-speech treatment model. Journal of Speech, Language, and Hearing Research, 46, 933-946.
69. O'Brian, S., Packman, A., & Onslow, M. (2008). Telehealth delivery of the Camperdown Program for adults who stutter. Journal of Speech, Language, and Hearing Research, 51, 1-12.
70. O'Donnell, J. J., Armson, J., & Kiefte, M. (2008). The effectiveness of SpeechEasy during situations of daily living. Journal of Fluency Disorders, 33, 99-119.
71. Onslow, M. (1995). A picture is worth more than any words [Comment]. Journal of Speech and Hearing Research, 38, 586-588.
72. Onslow, M. (1996). Behavioral management of stuttering (2nd ed.). San Diego, CA: Singular.
73. Onslow, M., Adams, R., & Ingham, R. (1992). Reliability of speech naturalness ratings of stuttered speech during treatment. Journal of Speech and Hearing Research, 35, 994-1001.
74. Onslow, M., Andrews, C., & Lincoln, M. (1994). A control-experimental trial of an operant treatment for early stuttering. Journal of Speech and Hearing Research, 37, 1244-1259.
75. Onslow, M., Costa, L., Andrews, C., Harrison, E., & Packman, A. (1996). Speech outcomes of a prolonged-speech treatment for stuttering. Journal of Speech and Hearing Research, 39, 734-749.
76. Onslow, M., Costa, L., & Rue, S. (1990). Direct early intervention with stuttering: Some preliminary data. Journal of Speech and Hearing Disorders, 55, 405-416.
77. Onslow, M., Jones, M., Menzies, R., O'Brian, S., & Packman, A. (2008). Meta analysis of Lidcombe Program treatment effects. Manuscript in preparation.
78. Onslow, M., O'Brian, S., Packman, A., & Rousseau, I. (2004). Long term follow up of speech outcomes for a prolonged-speech treatment for stuttering: The effects of paradox on stuttering treatment research. In A. K. Bothe (Ed.), Evidence-based treatment of stuttering: Empirical issues and clinical implications (pp. 231-244). Mahwah, NJ: Erlbaum.
79. Onslow, M., & Packman, A. (1999). Treatment recovery and spontaneous recovery from early stuttering: The need for consistent methods in collecting and interpreting data. Journal of Speech, Language, and Hearing Research, 42, 398-402.
80. Onslow, M., & Yaruss, J. S. (2007). Differing perspectives on what to do with a stuttering preschooler and why. American Journal of Speech-Language Pathology, 16, 65-68.
81. Packman, A., Onslow, M., O'Brian, S., & Huber, A. (2004). Measuring the outcomes of behavioural stuttering treatments: What are our data telling us? In A. K. Bothe (Ed.), Evidence-based treatment of stuttering: Empirical issues and clinical implications (pp. 245-258). Mahwah, NJ: Erlbaum.
82. Perkins, W. (1981). Measurement and maintenance of fluency. New York: Elsevier.
83. Perkins, W. H., Rudas, J., Johnson, L., Michael, W. B., & Curlee, R. F. (1974). Replacement of stuttering with normal speech. 3. Clinical effectiveness. Journal of Speech and Hearing Disorders, 39, 416-428.
84. Piantadosi, S. (1997). Clinical trials: A methodological perspective. New York: Wiley.
85. Pocock, S. J. (1983). Clinical trials. Chichester, United Kingdom: Wiley.
86. Pollard, R., Ellis, J. B., Finan, D., & Ramig, P. R. (in press). Effects of the SpeechEasy on objective and perceived aspects of stuttering: a six-month, Phase I clinical trial in naturalistic environments. Journal of Speech, Language, and Hearing Research.
87. Reed, C., & Godden, A. (1977). An experimental treatment using verbal punishment with two preschool stutterers. Journal of Fluency Disorders, 2, 225-233.
88. Riley, G. D., & Ingham, J. C. (2000). Acoustic duration changes associated with two types of treatment for children who stutter. Journal of Speech, Language, and Hearing Research, 43, 965-978.
89. Riley, J., & Riley, G. (1999). Speech motor training. In M. Onslow & A. Packman (Eds.), The handbook of early stuttering intervention. San Diego, CA: Singular.
90. Robey, R. (2005, May 24). An introduction to clinical trials. The ASHA Leader, pp. 6-7, 22-23.
91. Rosenthal, R. (1979). The "file drawer" problem and tolerance for null results. Psychological Bulletin, 86, 638-641.
92. Rousseau, I., Packman, A., Onslow, M., Harrison, L., & Jones, M. (2007). Language, phonology, and treatment time in the Lidcombe Program: A prospective study in a Phase II trial. Journal of Communication Disorders, 40, 382-397.
93. Ryan, B. P., & Van Kirk Ryan, B. (1983). Programmed stuttering therapy for children: Comparison of four establishment programs. Journal of Fluency Disorders, 8, 291-322.
94. Ryan, B. P., & Van Kirk Ryan, B. (1995). Programmed stuttering treatment for children: Comparison of two establishment programs through transfer, maintenance, and follow-up. Journal of Speech and Hearing Research, 38, 61-75.
95. Saint Laurent, L., & Ladouceur, R. (1987). Massed versus distributed application of the regulated-breathing method for stutterers and its long-term effect. Behavior Therapy, 18, 38-50.
96. Sidman, M. (1960). Tactics of scientific research. New York: Basic Books.
97. Siegel, G. (1987). The limits of science in communication disorders. Journal of Speech and Hearing Disorders, 52, 306-312.
98. Siegel, G. (1990). Conference on treatment efficacy: Concluding remarks. In L. Olswang, C. Thompson, S. Warren, & N. Minghetti (Eds.), Treatment efficacy research in communication disorders (pp. 233-237). Rockville, MD: American Speech-Language-Hearing Foundation.
99. Siegel, G. M., & Ingham, R. J. (1987). Theory and science in communication disorders. Journal of Speech and Hearing Disorders, 52, 99-104.
100. Siegel, G., & Young, M. (1987). Group designs in clinical research. Journal of Speech and Hearing Disorders, 52, 194-199.
101. Smith, G. C. S., & Pell, J. P. (2003). Parachute use to prevent death and major trauma related to gravitational challenge: Systematic review of randomised controlled trials. British Medical Journal, 327, 1451-1459.
102. Sommer, M., Koch, M. A., Paulus, W., Weiller, C., & Buchel, C. (2002). Disconnection of speech-relevant brain areas in persistent developmental stuttering. Lancet, 360(9330), 380-383.
103. Sommers, R. K., Brady, W. A., & Moore, W. H., Jr. (1975). Dichotic ear preferences of stuttering children and adults. Perceptual and Motor Skills, 41, 931-938.
104. Starkweather, C. W. (1993). Issues in the efficacy of treatment for fluency disorders. Journal of Fluency Disorders, 18, 151-168.
105. Starkweather, C. W., & Gottwald, S. R. (1993). A pilot study of relations among measures obtained at intake and discharge in a program of prevention and early intervention for stuttering. American Journal of Speech-Language Pathology, 2, 51-58.
106. St. Louis, K., & Westbrook, J. (1987). The effectiveness of treatment for stuttering. In L. Rustin, H. Purser, & D. Rowley (Eds.), Progress in the treatment of fluency disorders (pp. 235-257). London: Taylor & Francis.
107. Stokes, T., & Baer, D. (1977). An implicit technology of generalization. Journal of Applied Behavior Analysis, 10, 349-367.
108. Teesson, K., Packman, A., & Onslow, M. (2003). The Lidcombe behavioral data language of stuttering. Journal of Speech, Language, and Hearing Research, 46, 1009-1015.
109. Thomas, C., & Howell, P. (2001). Assessing efficacy of stuttering treatments. Journal of Fluency Disorders, 26, 311-333.
110. Trajkovski, N., Andrews, C., O'Brian, S., Onslow, M., & Packman, A. (2006). Treating stuttering in a preschool child with syllable timed speech: A case study. Behavior Change, 23(4), 270-277.
111. Webster, R. (1980). Evolution of a target-based behavioral therapy for stuttering. Journal of Fluency Disorders, 5, 303-320.
112. Whitehead, A. (2002). Meta-analysis of controlled clinical trials. Chichester; United Kingdom: Wiley.
113. Wilson, L., Onslow, M., & Lincoln, M. (2004). Telehealth adaptation of the Lidcombe Program of early stuttering intervention: Preliminary data. American Journal of Speech-Language Pathology, 13, 81-93.
114. Yaruss, I. S., Coleman, C., & Hammer, D. (2006). Treating preschool children who stutter: Description and preliminary evaluation of a family-focused treatment approach. Language, Speech, and Hearing Services in Schools, 37, 118-132.
115. Zhang, X., & Tomblin, J. B. (2003). Explaining and controlling regression to the mean in longitudinal research designs. Journal of Speech, Language, and Hearing Research, 46, 1340-1351.