Michele Robins

Treatment for Adolescents with Depression Study (TADS): Rationale, design, and methods

OBJECTIVES A rapidly growing empirical literature on the treatment of major depressive disorder (MDD) in youth supports the efficacy of short-term treatment with depression-specific cognitive-behavioral therapy or medication management with a selective serotonin reuptake inhibitor. These studies also identify a substantial probability of partial response and of relapse, which might be addressed by more intensive, longer-term treatments. METHOD 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 evaluate the short-term (12-week) and long-term (36-week) effectiveness of four treatments for adolescents with MDD: fluoxetine, cognitive-behavioral therapy, their combination, and, acutely, pill placebo. A volunteer sample of 432 subjects aged 12-17 years (inclusive) with a primary DSM-IV diagnosis of MDD who are broadly representative of patients seen in clinical practice will enter the study. The primary dependent measures rated blindly by an independent evaluator are the Childrens Depression Rating Scale and, for responder analysis, a dichotomized Clinical Global Impressions-Improvement score. Consistent with an intent-to-treat analysis, all patients, regardless of treatment status, return for all scheduled assessments. RESULTS This report describes the design of the trial, the rationale for the design choices made, and the methods used to carry out the trial. CONCLUSION When completed, TADS will improve our understanding of how best to initiate treatment for adolescents with MDD.

The Treatment for Adolescents With Depression Study (TADS): outcomes over 1 year of naturalistic follow-up.

OBJECTIVE The Treatment for Adolescents With Depression Study (TADS) evaluates the effectiveness of fluoxetine, cognitive-behavioral therapy (CBT), and their combination in adolescents with major depressive disorder. The authors report effectiveness outcomes across a 1-year naturalistic follow-up period. METHOD The randomized, controlled trial was conducted in 13 academic and community sites in the United States. Stages I, II, and III consisted of 12, 6, and 18 weeks of acute, consolidation, and continuation treatment, respectively. Following discontinuation of TADS treatments at the end of stage III, stage IV consisted of 1 year of naturalistic follow-up. The participants were 327 subjects between the ages of 12 and 17 with a primary DSM-IV diagnosis of major depressive disorder. No TADS treatment was provided during the follow-up period; treatment was available in the community. The primary dependent measures, rated by an independent evaluator blind to treatment status, were the total score on the Childrens Depression Rating Scale-Revised and the rate of response, defined as a rating of much or very much improved on the Clinical Global Impressions improvement measure. RESULTS Sixty-six percent of the eligible subjects participated in at least one stage IV assessment. The benefits seen at the end of active treatment (week 36) persisted during follow-up on all measures of depression and suicidality. CONCLUSIONS In contrast to earlier reports on short-term treatments, in which worsening after treatment is the rule, the longer treatment in the TADS was associated with persistent benefits over 1 year of naturalistic follow-up.

An exploratory analysis of the impact of family functioning on treatment for depression in adolescents

This article explores aspects of family environment and parent–child conflict that may predict or moderate response to acute treatments among depressed adolescents (N = 439) randomly assigned to fluoxetine, cognitive behavioral therapy, their combination, or placebo. Outcomes were Week 12 scores on measures of depression and global impairment. Of 20 candidate variables, one predictor emerged: Across treatments, adolescents with mothers who reported less parent–child conflict were more likely to benefit than their counterparts. When family functioning moderated outcome, adolescents who endorsed more negative environments were more likely to benefit from fluoxetine. Similarly, when moderating effects were seen on cognitive behavioral therapy conditions, they were in the direction of being less effective among teens reporting poorer family environments.

Relapse and Recurrence Prevention in the Treatment for Adolescents with Depression Study.

Relapse and recurrence in adolescent depression are important problems. Much less is known about relapse prevention compared to the acute treatment of depression in adolescents. Based on previous research, theoretical predictions, and clinical experience, the Treatment for Adolescents With Depression Study (TADS) protocol was designed to determine whether the usual high rates of relapse and recurrence could be decreased by extending acute treatment in the form of booster sessions that included (a) thorough education about the nature of depression, including its longitudinal course; (b) achievement of full symptom remission, (c) graded transfer of skills from therapist to adolescent (i.e., teaching the teen to be his or her own therapist); (d) focus on known risk factors for relapse, such as cognitive factors, family criticism, etc.; and (e) inclusion of the family as a function of need and developmental level. This article reviews the literature on risk factors for relapse and recurrence and then describes how these issues were approached in the cognitive behavioral treatment in TADS.

Characteristics and Components of the TADS CBT Approach.

In this paper, we describe the Acute phase of a cognitive-behavioral therapy (CBT) developed for and utilized in the Treatment for Adolescents with Depression Study (TADS). The Acute phase of TADS CBT consists of eight skills that were considered essential to any CBT intervention for adolescent depression (e.g., mood monitoring, increasing pleasant activities, identifying cognitive distortions and developing realistic counter-thoughts). In addition, five optional individual CBT skills (e.g., relaxation, affect regulation) can be incorporated into treatment, depending on the needs of the adolescent. We describe each of these individual skills by reviewing the rationale for their inclusion in the treatment protocol and describing the format that is used to teach the skill area. Recommendations are provided for dealing with common challenges that can occur in the teaching of each skill module. It is our hope that clinicians will find this a useful introduction to this particular form of treatment and a practical guide to dealing with clinical problems common to the delivery of any cognitive behavioral intervention with depressed teens.

Service Use and Costs of Care for Depressed Adolescents: Who Uses and Who Pays?.

Major depressive disorder is common in adolescence and is associated with significant morbidity and family burden. Little is known about service use by depressed adolescents. The purpose of this article is to report the patterns of services use and costs for participants in the Treatment for Adolescents with Depression Study sample during the 3 months before randomization. Costs were assigned across three categories of payors: families, private insurance, and the public sector. We examined whether costs from payors varied by baseline covariates, such as age, gender, insurance status, and family income. The majority (71%) of depressed youth sought services during the 3-month period. Slightly more than one-fifth had contact with a behavioral health specialist. The average participant had just under

The Treatment for Adolescents with Depression Study (TADS): Long-term effectiveness and safety outcomes

300 (SD =

Predictors and Moderators of Acute Outcome in the Treatment for Adolescents With Depression Study (TADS)

437.67, range =

Functioning and quality of life in the Treatment for Adolescents with Depression Study (TADS).

0–

The Treatment for Adolescents with Depression Study (TADS): Demographic and clinical characteristics

3,747.71) in treatment-related costs, with most of these costs borne by families and private insurers.