The treatment for adolescents with depression study team. (2003). treatment for adolescents with depression study (tads): rationale, design, and methods. (2003) data trends 87

Summaries of research on mental health services for children and adolescents and their families The Treatment for Adolescents with Depression Study Team. (2003). Treatment for Adolescents with Depres- sion Study (TADS): Rationale, design, and methods. Journal of the American Academy of Child andAdolescent Psychiatry, 42(5), 531-542.
Keywords: adolescence, depression, treatment, cognitive-behavioral therapy, fluoxetine (Prozac), trial Funded by the National Institute of Mental Health, the Treatment for Adolescents with Depression Study (TADS) is a multicenter, randomized, masked effectiveness trial designed to test the hypothesis that acombined treatment of cognitive-behavioral therapy (CBT) with the selective serotonin reuptake inhibitor(SSRI) fluoxetine (FLX), is superior to either psychotherapy or pharmacological therapy alone, in the treat-ment of Major Depressive Disorder (MDD) in adolescents (see text box). In this article, the TADS teamoutlines the design, rationale, and methodology of the trial.
A volunteer clinical sample of 432 youth ages 12-17 will be Specific Aims of TADS
recruited from site clinics, primary care physicians, mental health providers, schools, juvenile justice facilities, and local media (this fluoxetine (FLX); (b) cognitive-behavioral stage is expected to conclude by spring, 2003). In order to be therapy (CBT); (c) a combination of FLX and CBT (COMB), and; (d) placebo (PBO) eligible for the study, teens must have a DSM-IV diagnosis of MDD, and be antidepressant-free before the start of the study.
(MDD) symptoms and patient disability over Teens having other disorders (i.e., bipolar disorder, severe conduct 2. To compare the effectiveness of the three disorder, pervasive developmental disorder, thought disorder, and substance abuse) are ineligible for the study because treatment may require additional or different interventions. Potential candidates 3. To compare the acute time-action profiles for the study who decline to participate or who do not meet eligibility requirements will be offered clinically appropriate associated impairment, and use of mental health/medical services for FLX, CBT, and Primary outcome measures include the Children’s Depression Rating Scale-Revised, and the Clinical Global Impressions-Im- provement scale. An independent evaluator will collect primary outcome data at baseline, 6, 12, 18, 24, 30, and 36 weeks. Quality assurance will include: (a) centralized training by the NIMH; (b) a comorbid internalizing and externalizing symptoms, treatment expectations, and “train the trainers” model whereby site managers monitor local fidelity; (c) mechanisms to provide prompt feedback; (d) telecon- 6. To examine the acceptability and cost- ferencing; and (e) the extensive use of manuals (11 total). Proce- effectiveness of FLX, CBT, and COMB for the treatment of MDD in adolescents. dures are also in place to meet clinical emergencies or contingencies that may arise during the course of the trial.
Selected teens will be randomized to receive, on an outpatient basis, one of the following four treatment options: (a) FLX, (b) CBT, (c) FLX and CBT combined (COMB), or (d) placebo (PBO). Stage I (acute) lastsfor 12 weeks. During this stage, teens in the FLX group will receive a flexible-dosing schedule devised toachieve normalization (10-40 mg. maximum). Teens in the PBO group will be advised of their medicationstatus at the end of Stage I, and appropriate follow-up efforts will be made, depending upon the teen’sresponse to PBO. Teens receiving CBT will attend required skillbuilding sessions and optional sessions willalso be available; this CBT intervention is modified to treat MDD, and includes parent and family sessions.
During the first half of Stage I, the CBT intervention includes services such as education about depressionand the TADS CBT approach (i.e., psychoeducation), goal setting, mood-monitoring and cognitive restruc-turing; the latter six weeks focus on issues chosen by the therapist, teen, and parents to meet needs specific to Prepared by the Research and Training Center for Children’s Mental Health, Louis de la Parte Florida Mental Health Institute, University of South Florida, 13301 Bruce B. Downs Blvd. Tampa, FL 33612, (813) 974-4661 For more information, contact [email protected]; Website: http://rtckids.fmhi.usf.edu The Center is jointly funded by the National Institute on Disability and Rehabilitation and the Center for Mental Health Services, SAMHSA, U.S.
Department of Health and Human Services.
Summaries of research on mental health services for children and adolescents and their families the child and his or her family. Teens in the COMB group will receive both FLX and CBT and, “to allow forlimited integration between medication management and CBT in Stages I and II” (p. 538), CBT and medica-tion management will be functionally independent of each other. However, in cases where the teen does notrespond as well as expected to the COMB treatment, the FLX clinician and CBT therapist will then consultwith each other to evaluate the teen’s overall progress and jointly decide whether changes to the FLX dosingstrategy are required.
Stage II (graduated maintenance) lasts for six weeks, and teens continue to receive treatment by the same clinician and/or therapist they saw during Stage I. Depending upon how well teens respond to the interven-tion, treatments may be leveled or increased. For example, teens who respond well to CBT will be given bi-weekly follow-up visits that are 30-50 minutes long, whereas those who respond only partially will haveweekly, 50-60 minute visits. At this stage, teens receiving fluoxetine may have their medication increased to amaximum of 60 mg. Next, Stage III (consolidation) continues for 18 weeks. During this period, no down-ward adjustments of medication are made (unless there are medically adverse effects), and no new conceptsare introduced into the CBT program. Stage IV includes open follow-up for 52 weeks. All teens receivefollow-up assessments, including those in the PBO group.
According to the TADS research group, this study represents “the best compromise between the dictates of the RFP, ethical considerations, scientific rigor and credibility, stakeholder concerns, feasibility of imple-mentation, and cost” (p. 535); they expect to publish their results at the conclusion of each stage. While thismay be the case, there are several things that are important to note. First, in this traditional randomizeddesign, families are provided no choice of treatment. This is inconsistent with the values expressed in therecently released President’s New Freedom Commission report, which calls for mental health care that “isconsumer and family driven.” Given that “choice” alone has been found to be an evidence-based process, italso removes this possible contributor to success.
Second, although there is some flexibility in the CBT intervention, this is basically a study using highly standardized interventions. This is the case despite the fact that the authors report that both interventions –medication and CBT – alone are effective for 60% of the youth served with about half of those relapsingwithin a year. Given this limited success rate, one would anticipate potentially incorporating a more compre-hensive, individualized intervention as part of the study rather than simply combining two highly standard-ized interventions, each of which has been found to have limited success over a one year period. Within anindividualized intervention, medication or CBT could certainly be used if indicated and selected by theadolescent, parents, and treatment team. The traditional approach taken in this study is again inconsistentwith the recommendations of the President’s Commission, which calls for “a personalized, highly individual-ized health management program.” This is particularly important given the high rate of co-occurringproblems associated with depression. Nor is there any mention of building on strengths or tailoring interven-tions to meet the needs of diverse racial or ethnic groups.
In summary, this is a large and important study of a significant mental disorder affecting many adoles- cents. It has a strong research design from the perspective of internal validity but unfortunately fails to beconsistent with recommendations from the President’s Commis- Prepared by the Research and Training Center for Children’s Mental Health, Louis de la Parte Florida Mental Health Institute, University of South Florida, 13301 Bruce B. Downs Blvd. Tampa, FL 33612, (813) 974-4661 For more information, contact [email protected]; Website: http://rtckids.fmhi.usf.edu The Center is jointly funded by the National Institute on Disability and Rehabilitation and the Center for Mental Health Services, SAMHSA, U.S.
Department of Health and Human Services.

Source: http://datatrends.fmhi.usf.edu/summary_87.pdf