As the field of counseling moves toward evidence-based practice, researchers and clinicians may be interested in conducting randomized clinical trials. Although the randomized clinical trial is not the only method for conducting effectiveness studies of counseling interventions, it is a design that can produce important results. This article discusses the foundational steps in designing a randomized clinical trial and provides suggestions for researchers who are interested in conducting this type of research.
American Psychological Association. (2005). Policy statement on evidence-based practice in psychology. Retrieved September 20, 2009, from http://www2.apa.org/practice/ebpstatement.pdf
2.
American Psychological Association (2010). Publication manual of the American Psychological Association. Washington, DC: Author.
3.
APA Publications and Communications Board Working Group on Journal Article Reporting Standards. (2008). Reporting standards for research in psychology: Why do we need them? What might they be?American Psychologist, 63(9), 839–851. doi:10.1037/0003-066X.63.9.839.
4.
AttkissonC.ZwickR. (1983). The client satisfaction questionnaire: Psychometric properties and correlations with service utilization and psychotherapy outcome. Evaluation and Program Planning, 5, 233–237. doi:10.1016/0149-7189(82)90074.
5.
BaronR. M.KennyD. A. (1986). The moderator–mediator variable distinction in social psychological research: Conceptual, strategic, and statistical consideration. Journal of Personality and Social Psychology, 51, 1173–1182. doi:10.1037/0022-3514.51.6.1173.
6.
BellgA. J.BorrelliB.ResnickB.HechtJ.MinicucciD. S.OryM. (2004). Enhancing treatment fidelity in health behavior change studies: Best practices and recommendations from the NIH Behavior Change Consortium. Health Psychology, 23, 443–451. doi:10.1037/0278-6133.23.5.443.
7.
BickmanL.ReichS. M. (2009). Randomized controlled trials: A gold standard with feet of clay. In DonaldsonS. I.ChristieC. A.MarkM. M. (Eds.), What counts as credible evidence in applied research and evaluation practice? (pp. 51–72). Thousand Oaks, CA: Sage.
8.
CookT. D.CampbellD. T. (1979). Quasi-experimentation: Design and analysis issues for field settings. Boston: Houghton Mifflin.
9.
Crits-ChristophP.MintzJ. (1991). Implications of therapist effects for the design and analysis of comparative studies of psychotherapies. Journal of Consulting and Clinical Psychology, 59, 20–26. doi:10.1037/0022-006X.59.1.20.
10.
Del BocaF. K.DarkesJ. (2007a). Enhancing the validity and utility of RCTs in addictions treatment research: I. Treatment implementation and research design. Addiction, 102, 1047–1056.
11.
Del BocaF. K.DarkesJ. (2007b). Enhancing the validity and utility of RCTs in addictions treatment research: II. Participant samples and assessment. Addiction, 102, 1194–1203. doi:10.1111/j.1360-0443.2007.01862.
12.
FarnsworthJ. R.HessJ. Z.LambertM. J. (August, 2001). Frequency of outcome measures used in psychotherapy. Poster presented at the 109th Annual Conference of the American Psychological Association, San Francisco, CA.
13.
GreshamF. M. (2005). Treatment integrity and therapeutic change: Commentary on Perepletchikova and Kazdin. Clinical Psychology: Science and Practice, 12, 391–394. doi:10.1093/clipsy/bpi048.
14.
HansonW. E.MerkerB. M. (2005). Review of the OQ-45.2 (Outcome Questionnaire). In
SpiesR. A.PlakeB. S. (Eds.), The sixteenth mental measurements yearbook (pp. 737–739). Lincoln, NE: Buros Institute of Mental Measurements.
15.
HeppnerP. P.KivlighanD. M.Jr.WampoldB. E. (2008). Research design in counseling (3rd ed.). Belmont, CA: Thomson Brooks / Cole.
16.
HillC. E.LambertM. J. (2004). Methodological issues in studying psychotherapy processes and outcomes. In
LambertM. J. (Ed.), Bergin and Garfield’s handbook of psychotherapy and behavior change (5th ed., pp. 84–135). New York: Wiley.
17.
HsuL. M. (1989). Random sampling, randomization, and equivalence of contrasted groups in psychotherapy outcome research. Journal of Consulting and Clinical Psychology, 57, 131–137. doi:10.1037/0022-006X.57.1.131.
18.
HunsleyJ.Rumstein-McKeanO. (1999). Improving psychotherapeutic services via RCTs, treatment manuals, and component analysis designs. Journal of Clinical Psychology, 55, 1507–1517.
19.
JuddC. M.KennyD. A.McClellandG. H. (2001). Estimating and testing mediation and moderation in within-subject designs. Psychological Methods, 6, 115–134. doi:10.1037/1082-989X.6.2.115.
20.
KazdinA. E. (2008). Evidence-based treatments and delivery of psychological services: Shifting our emphases to increase impact. Psychological Services, 5, 201–215. doi:10.1037/a0012573.
21.
KendallP. C.ButcherJ. N.HolmbeckG. N. (1999). Handbook of research methods in clinical psychology (2nd ed.). Hoboken, NJ: Wiley.
22.
KendallP. C.GoschE.FurrJ. M.SoodE. (2008). Flexibility within fidelity. Journal of the American Academy of Child & Adolescent Psychiatry, 47, 987–993. doi:10.1097/CHI.0b013e31817eed2f.
23.
KendallP. C.HolmbeckG.VerduinT. (2003). Methodology, design, and evaluation in psychotherapy. In
LambertM. J. (Eds.), Bergin and Garfield’s handbook of psychotherapy and behavior change (pp. 16–43). New York: Wiley.
24.
KennyD. A.JuddC. M. (1986). Consequences of violating the independence assumption in analysis of variance. Psychological Bulletin, 99, 422–431. doi:10.1037/0033-2909.99.3.422.
25.
KiresuckT. J.SmithA.CardilloJ. E. (1994). Goal Attainment Scaling: Application, theory, and measurement. Hillsdale, NJ: Erlbaum.
26.
KrauseM. S.HowardK. I. (2003). What random assignment does and does not do. Journal of Clinical Psychology, 59, 751–766. doi:10.1002/jclp.10170.
27.
LambertM. J.VermeerschD. A. (2008). Measuring and improving psychotherapy outcome in routine practice. In
BrownS. D.LentR. W. (Eds.), Handbook of counseling psychology (4th ed., pp. 233–248). New York: Wiley.
28.
NelsonT. D.SteeleR. G. (2006). Beyond efficacy and effectiveness: A multifaceted approach to treatment evaluation. Professional Psychology: Research and Practice, 37, 389–397. doi:10.1037/0735-7028.37.4.389.
29.
NorcrossJ. C.BeutlerL. E.LevantR. F. (Eds.). (2006). Evidence-based practices in mental health: Debate and dialogue on the fundamental questions. Washington, DC: American Psychological Association. doi:10.1037/11265-000.
30.
OeiT. P. S.ShuttlewoodG. J. (1999). Development of a satisfaction with therapy and therapist scale. Australian and New Zealand Journal of Psychiatry, 33(5), 748–753. doi:10.1046/j.1440-1614.1999.00628.x.
31.
OlgesB. M.LambertM. J.FieldsS. A. (2002). Essentials of outcome assessment. New York: Wiley.
32.
OrlinskyD. E.RonnestadM. H.WillutzkiU. (2004). Fifty years of psychotherapy process-outcome research: Continuity and change. In
LambertM. J. (Eds.), Bergin and Garfield’s handbook of psychotherapy and behavior change (5th ed., pp. 307–389). New York: Wiley.
33.
PalsS. L.MurrayD. M.AlfanoC. W.ShadisW. R.HannanP. J.BakerW. L. (2008). Individual randomized group treatment trials: A critical appraisal of frequently used designs and analytic approaches. American Journal of Public Health, 98, 1418–1424. doi:10.2105/AJPH.2007.127027.
34.
PerepletchikovaF.KazdinA. E. (2005). Treatment integrity and therapeutic change: Issues and research recommendations. Clinical Psychology: Science and Practice, 12, 365–383. doi:10.1093/clipsy/bpi045.
35.
PerepletchikovaF.TreatT. A.KazdinA. E. (2007). Treatment integrity in psychotherapy research: Analysis of the studies and examination of the associated factors. Journal of Consulting and Clinical Psychology, 75, 829–841. doi:10.1037/0022-006X.75.6.829.
36.
PfeifferS. I. (2005). Review of the OQ-45.2 (Outcome Questionnaire). In
SpiesR. A.PlakeB. S. (Eds.). The sixteenth mental measurements yearbook (pp. 739–741). Lincoln, NE: Buros Institute of Mental Measurements.
37.
SchlosserR. W. (2002). On the importance of being earnest about treatment integrity. AAC: Augmentative and Alternative Communication, 18, 36–44. doi:10.1080/714043395.
38.
SteinerD. L. (2002). The case of the missing data: Methods of dealing with dropouts and other research vagaries. Canadian Journal of Psychiatry, 47, 68–75.
39.
StrubeM. J. (1991). Small sample failure of random assignment: A further examination. Journal of Consulting and Clinical Psychology, 59, 346–350. doi:10.1037/0022-006X.59.2.346.
40.
WicksP. (2007). Recruiting your “control” group: Linchpin or afterthought. The Psychologist, 20(1):22–25.
