Child/Adolescent Anxiety Multimodal Study Research Articles

Substance use outcomes from the Child/Adolescent Anxiety Multimodal Extended Long-term Study (CAMELS).

Substance use problems and anxiety disorders are both highly prevalent and frequently cooccur in youth. The present study examined the benefits of successful anxiety treatment at 3-12 years after treatment completion on substance use outcomes (i.e. diagnoses and lifetime expected use). The sample was from the Child/Adolescent Anxiety Multimodal Extended Long-term Study (CAMELS), a naturalistic follow-up study to the Child/Adolescent Anxiety Multimodal Study (CAMS) which randomized youth to cognitive behavioral therapy (CBT; Coping cat), medication (sertraline), their combination, or pill placebo. The first CAMELS visit occurred an average of 6.5 years following CAMS randomization. Participants were 319 youth (65.4% of the CAMS sample), aged 7-17 years at CAMS baseline assessment with a mean age of 17.6 years (range: 11-26 years) at the time of the first CAMELS follow-up. Substance use outcomes included diagnoses as well as lifetime substance use (i.e. alcohol and tobacco use). Eleven of 319 (3.4%) CAMELS participants were diagnosed with a substance use disorder at the initial follow-up visit. When compared to the population lifetime rate of 11.4%, the rate of diagnoses in the posttreated sample was significantly lower. Additionally, rates of lifetime alcohol use were lower than population rates at the initial and final follow-up visits. Rates of lifetime tobacco use were similarly lower than lifetime population rates at the initial visit (driven by significantly lower rates in the CBT treatment condition), but higher by the final visit. Furthermore, treatment remission (but not treatment response) was associated with a lower rate of substance use diagnoses at the initial follow-up visit, although rates of lifetime alcohol and tobacco use did not differ by treatment outcome. Anxiety treatments confer a beneficial impact on problematic substance use (i.e. diagnoses) as well as on expected substance use (i.e. alcohol and tobacco use) for on average, a period of 6.5 years.

Initiation of Pharmacotherapy Following CBT in Anxious Youth

Objective: To describe youth with anxiety disorders who initiate pharmacotherapy following cognitive-behavioral therapy (CBT) in a prospective, randomized trial and to identify predictors of the decision to use pharmacotherapy.Methods: Data from CBT-treated youth (aged 7-17 years, N = 139) in the Child/Adolescent Anxiety Multimodal Study (CAMS), a multisite, randomized controlled trial that examined the efficacy of CBT, sertraline, their combination, and placebo for pediatric anxiety disorders (DSM-IV criteria), were evaluated. Initiation of pharmacotherapy following acute CBT treatment was examined over a 24-week period; the study was conducted from December 2002 through May 2007. Logistic regression models identified features associated with initiating pharmacotherapy, including symptom severity (scores on the Pediatric Anxiety Rating Scale [PARS] and the Screen for Child/Adolescent Anxiety Related Disorders [SCARED]), parent and child treatment expectations, Clinical Global Impressions-Improvement/Severity of Illness (CGI-I/S) scores, and clinical and demographic characteristics.Results: CBT non-remitters (CGI-S score > 2) who began pharmacotherapy (n = 10) and those who did not (n = 80) were similar in age (P = .445), sex (P = .324), race (P = .242), and symptom severity based on CGI-S (P = .753), PARS (P = .845), or SCARED (P = .678) scores. Mean ± SD improvement (CGI-I score) at week 12 did not differ between patients who initiated pharmacotherapy (3.00 ± 0.82) and those who did not (2.69 ± 0.89, P = .798). However, in the logistic regression, age (P = .003), race (P = .021), and parents' treatment expectation (P = .037) were significantly associated with the likelihood of initiating pharmacotherapy. Beginning pharmacotherapy in CBT non-remitters was associated with a significant improvement in CGI-S score (mean ± SD decline: -0.99 ± 0.46; 95% credible interval [CrI], -0.088 to -1.89; P = .035) from week 12 to week 36 compared to patients who did not begin pharmacotherapy.Discussion: Very few CBT non-remitters initiated pharmacotherapy, although beginning medication produced significant improvement. Younger and racial and ethnic minoritized patients as well as those with lower expectations for CBT were less likely to begin medication.Trial Registration: ClinicalTrials.gov identifier: NCT00052078.

33.3 INTRODUCTION TO PROBABILITY-BASED STATISTICAL APPROACHES IN CHILD AND ADOLESCENT PSYCHIATRY

This session aims to provide child and adolescent psychiatrists with an overview and application of probability-based tools, especially Bayesian hierarchical models (BHMs) in child and adolescent mental health. This presentation will introduce probability-based approaches and demystify modern computational methods such as Monte Carlo methods. First, the presentation will review contemporary Bayesian understanding of probability and its application to risk prediction and measuring outcomes in randomized controlled trials. Second, the presentation will describe the differences between modern approaches to analyzing clinical trials (vs standard mixed models for repeated measures [MMRMs]) and how clinicians can leverage this to understand variation in outcomes in clinical trials. Third, the presentation will describe how these approaches can be leveraged to understand how individual patient characteristics influence response. These concepts will be applied to analyses of data from the Child/Adolescent Anxiety Multimodal Study (CAMS). Probabilistic models more precisely estimate treatment effects and decrease the restrictive assumptions inherent to standard approaches. The “Bayesian machinery” of Markov chain Monte Carlo (MCMC) methods—when applied to CAMS—reveals that sertraline monotherapy (n = 134) increases the probability of responses week over week (weeks 0 to 4, p < 0.0001; weeks 4 to 8, p < 0.0004), but additional improvement in anxiety symptoms is unlikely from week 8 to week 12 (p = 0.39). For clinicians, these analyses suggest that if a patient has not responded by week 8, additional benefit is unlikely during the next 4 weeks (p = 0.39). These contemporary probability-based approaches underscore the problems associated with large sample assumptions, unobserved heterogeneity, and hypothesis testing for complex models across individuals in child and adolescent psychiatry. Moreover, the application to CAMS reveals that this inference framework can also be enhanced by explicitly modeling the time dependencies in the data. With these approaches, clinicians can move beyond “average response” and these models can inform recommendations for treatment trial duration and help to understand which patients benefit from what treatments.

Impact of treatment improvement on long-term anxiety: Results from CAMS and CAMELS.

This article examined associations between change in youth and family characteristics during youth anxiety treatment and long-term anxiety severity and overall functioning. Participants (N = 488; age 7-17 years; 45% male; 82% white) were randomized to 12 weeks of cognitive behavioral therapy (Coping Cat), medication (sertraline), their combination, or pill placebo in the Child/Adolescent Anxiety Multimodal Study (CAMS). A subset participated in the naturalistic follow-up Child/Adolescent Anxiety Multimodal Extended Long-term Study (CAMELS; n = 319; 3.70-11.83 years post-treatment). The current secondary analyses examined how change in anxiety severity (Child Global Impression-Severity), overall functioning (Children's Global Assessment Scale), caregiver psychopathology (Brief Symptom Inventory), caregiver strain (Family Burden Assessment Scale), and family dysfunction (Brief Family Assessment Measure) during CAMS was associated with anxiety severity and overall functioning years later (M = 7.72 years). CAMS procedures were registered on clinialtrials.gov. Improvements in factors related to functioning (i.e., overall functioning, family dysfunction, caregiver strain) were associated with improvements in anxiety severity in CAMELS (|βys| ≥ .04, ps ≤ .04). Improvements in factors related to psychopathology (i.e., anxiety severity, caregiver psychopathology) were associated with improvements in overall functioning in CAMELS (|βys| ≥ .23, ps ≤ .04). It was changes in each of the variables examined (rather than baseline values) that predicted anxiety severity and overall functioning. Both youth and family factors play a significant role in long-term treatment outcomes. Therapists would be wise to monitor how these factors change throughout treatment. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

INTEGRATING RECENT RESEARCH FINDINGS INTO THE CARE OF CHILDREN AND ADOLESCENTS WITH ANXIETY DISORDERS

This presentation aims to apply recent findings from the Child/Adolescent Anxiety Multimodal Study (CAMS) and Child/Adolescent Anxiety Multimodal Extended Long-Term Study (CAMELS) to individualize psychotherapeutic and psychopharmacologic treatments for youth with anxiety disorders and to enhance long-term outcomes.

7.1 ENHANCING CLINICAL DECISION MAKING TO IMPROVE OUTCOMES FOR ANXIOUS YOUTH

Although the Child/Adolescent Anxiety Multimodal Study (CAMS) trial demonstrated the efficacy of medication, CBT, and combined treatments for child anxiety, remission is often difficult to achieve in the short term, and longer-term relapse is relatively common. The objective of this presentation is to review factors impacting treatment response for anxiety and to demonstrate how they can be used to inform clinical decision making that leads to more robust therapeutic outcomes.

Anxiety Symptoms Differ in Youth With and Without Tic Disorders.

We compared anxiety symptoms in youth with and without tic disorders by comparing scores on the Multidimensional Anxiety Scale for Children (MASC) in youth with tic disorders to those in a concurrent community control group and in a group of treatment-seeking anxious youth from the Child/Adolescent Anxiety Multimodal Study (CAMS). Data from 176 youth with tic disorders, 93 control subjects, and 488 CAMS participants were included. Compared to youth with tic disorders, controls had lower total MASC scores (p < 0.0001) and CAMS participants had similar total MASC scores (p = 0.13). Separation Anxiety (p = 0.0003) and Physical Symptom (p < 0.0001) subscale scores were higher in youth with tic disorders than in CAMS participants. We conclude that the anxiety symptom profile differs in youth with and without tic disorders, which may have important implications for targeting treatment of anxiety in youth with tic disorders.

Longitudinal Study of Sleep and Internalizing Problems in Youth Treated for Pediatric Anxiety Disorders.

The current study examined prospective bidirectional links between dysregulated sleep, and anxiety and depression severity across 4years, among youth with a history of anxiety disorder. Participants were 319 youth (age 11-26years), who previously participated in a large multisite randomized controlled trial for the treatment of pediatric anxiety disorders, Child/Adolescent Anxiety Multimodal Study (CAMS), and subsequently enrolled in a naturalistic follow-up, Child/Adolescent Anxiety Multimodal Extended Long-term Study (CAMELS), an average of 6.5years later. They participated in four annual visits that included self-report items of dysregulated sleep and semi-structured multi-informant interviews of anxiety and depression. Dysregulated sleep was bidirectionally associated with clinician-rated anxiety and depression symptom severity across adolescence and young adulthood. However, these bidirectional relationships were attributable to youth mean levels of dysregulated sleep, and anxiety and depression severity over the 4 years. Elevations in dysregulated sleep at each visit, relative to mean levels, did not predict worse anxiety or depression severity 1 year later. Likewise visit-specific elevations in anxiety and depression severity, as opposed to average levels, did not predict higher levels of dysregulated sleep at the next visit. Having higher levels of dysregulated sleep or more severe internalizing problems across the four-year period, as opposed to reporting a relative increase in symptom severity at a particular visit, posed greater risk for poor mental health. Interventions should continue to assess and treat persistent sleep problems alongside anxiety and depression.

Mood and suicidality outcomes 3-11 years following pediatric anxiety disorder treatment.

Youth anxiety interventions have potential to reduce risk for depression and suicidality. This naturalistic follow-up of the multi-site, comparative treatment trial, inking and behavior, and depressive symptoms 3-11 years (mean 6.25 years) following 12-week evidence-based youth anxiety treatment. Participants (N = 319; 10-26 years, mean 17 years) completed semiannual questionnaires and annual diagnostic interviews for 4 years. One-fifth (20.4%) of the sample met DSM-IV criteria for a mood disorder, 32.1% endorsed suicidal ideation, and 8.2% reported suicidal behavior. Latent class growth analysis yielded two linear trajectories of depressive symptoms, and 85% of the sample demonstrated a persistent low-symptom course over seven assessments. Child/Adolescent Anxiety Multimodal Study (CAMS) 12-week treatment outcome (positive response, remission) and treatment condition (cognitive behavior therapy [CBT], medication, CBT + medication, pill placebo) were not associated with subsequent mood disorder or suicidal thinking. CAMS remission predicted absence of suicidal behavior, and treatment response and remission predicted low depressive symptom trajectory. Greater baseline self-reported depressive symptoms predicted all long-term mood outcomes, and more negative life events predicted subsequent mood disorder, depressive symptom trajectory, and suicidal ideation. Effective early treatment of youth anxiety, including CBT, medication, or CBT + medication, reduces risk for subsequent chronic depressive symptoms and suicidal behavior. Attention to (sub)clinical depressive symptoms and management of negative life events may reduce odds of developing a mood disorder, chronic depressive symptoms, and suicidality. Findings contribute to evidence that early intervention for a primary disorder can serve as secondary prevention.

The Impact of Treatment Expectations on Exposure Process and Treatment Outcome in Childhood Anxiety Disorders.

This study examined the relationship between caregivers' and youths' treatment expectations and characteristics of exposure tasks (quantity, mastery, compliance) in cognitive-behavioral therapy (CBT) for childhood anxiety. Additionally, compliance with exposure tasks was tested as a mediator of the relationship between treatment expectations and symptom improvement. Data were from youth (N = 279; 7-17years old) enrolled in the Child/Adolescent Anxiety Multimodal Study (CAMS) and randomized to cognitive-behavioral therapy (CBT) or the combination of CBT and sertraline for the treatment of separation anxiety disorder, generalized anxiety disorder, and social phobia. Caregivers and youth independently reported treatment expectations prior to randomization, anxiety was assessed pre- and post-treatment by independent evaluators blind to treatment condition, and exposure characteristics were recorded by the cognitive-behavioral therapists following each session. For both caregivers and youths, more positive expectations that anxiety would improve with treatment were associated with greater compliance with exposure tasks, and compliance mediated the relationship between treatment expectations and change in anxiety symptoms following treatment. Additionally, more positive parent treatment expectations were related to a greater number and percentage of sessions with exposure. More positive youth treatment expectations were associated with greater mastery during sessions focused on exposure. Findings underscore the importance of addressing parents' and youths' treatment expectations at the outset of therapy to facilitate engagement in exposure and maximize therapeutic gains.

Pharmacotherapy Adherence for Pediatric Anxiety Disorders: Predictors and Relation to Child Outcomes.

Pharmacotherapy is considered an evidenced-based treatment for anxious youth. There is a need to better understand the relation between medication adherence and child outcomes. This study prospectively examined:1) baseline predictors of adherence and 2) the relation between medication adherence and clinical outcomes in children and adolescents with anxiety disorders. Participants were 349 youth randomized to sertraline, pill placebo, or sertraline plus cognitive behavioral therapy in the Child/Adolescent Anxiety Multimodal Study (CAMS) and followed over 12 weeks. The measure of pharmacotherapy adherence used was pharmacotherapist (PT) ratings of adherence at each session. Four domains of baseline predictors were examined (demographics, child clinical variables, family/parent variables, and treatment variables). Multiple regression analyses revealed few significant predictors of adherence. The most robust predictors of greater adherence were living with two parents and parents' positive expectations that medication would lead to better outcomes. Pharmacotherapists' ratings of higher adherence predicted higher global functioning at post treatment and treatment responder status. In order to increase adherence, improving expectations and instilling hope for positive outcomes and problem solving ways to overcome pragmatic barriers associated with single parent families is recommended.

Results From the Child/Adolescent Anxiety Multimodal Extended Long-Term Study (CAMELS): Primary Anxiety Outcomes

To report anxiety outcomes from the multisite Child/Adolescent Anxiety Multimodal Extended Long-term Study (CAMELS). Rates of stable anxiety remission (defined rigorously as the absence of all DSM-IV TR anxiety disorders across all follow-up years) and predictors of anxiety remission across a 4-year period, beginning 4 to 12 years after randomization to 12 weeks of medication, cognitive-behavioral therapy (CBT), their combination, or pill placebo were examined. Examined predictors of remission included acute treatment response, treatment assignment, baseline child and family variables, and interim negative life events. Data were from 319 youths (age range 10.9-25.2 years; mean age 17.12 years) originally diagnosed with separation, social, and/or generalized anxiety disorders and enrolled in the multi-site Child/Adolescent Anxiety Multimodal Study (CAMS). Participants were assessed annually by independent evaluators using the age-appropriate version of the Anxiety Disorders Interview Schedule and completed questionnaires (eg, about family functioning, life events, and mental health service use). Almost 22% of youth were in stable remission, 30% were chronically ill, and 48% were relapsers. Acute treatment responders were less likely to be in the chronically ill group (odds ratio= 2.73; confidence interval= 1.14-6.54; p< .02); treatment type was not associated with remission status across the follow-up. Several variables (eg, male gender) predicted stable remission from anxiety disorders. Findings suggest that acute positive response to anxiety treatment may reduce risk for chronic anxiety disability; identified predictors can help tailor treatments to youth at greatest risk for chronic illness. Child and Adolescent Anxiety Disorders (CAMS). http://clinicaltrials.gov/; NCT00052078.

Monotherapy Insufficient in Severe Anxiety? Predictors and Moderators in the Child/Adolescent Anxiety Multimodal Study

This secondary analysis of the Child/Adolescent Anxiety Multimodal Study (CAMS) used baseline patient characteristics to identify prognostic subgroups of children based on likelihood of remission. We also investigated predictors and moderators of outcome. CAMS randomized 488 youths with generalized, social, and separation anxiety disorders to cognitive behavioral therapy (CBT), sertraline, both, or pill placebo. Outcomes were Week 12 child, parent, and independent evaluator (IE) ratings of child anxiety. We used receiver operating characteristics analysis and stepwise regression to identify predictors and moderators of outcome. Severe anxiety, lower socioeconomic status, and comorbid obsessive-compulsive disorder predicted higher IE-rated anxiety posttreatment; child-rated social anxiety predicted poorer outcomes reported by all informants. Regarding moderators, Hispanic ethnicity predicted higher IE-rated anxiety after CBT and higher parent-rated anxiety after sertraline. In youths with severe anxiety (Pediatric Anxiety Rating Scale ≥ 20, <italic>n</italic> = 220), combination treatment increased remission (relative risk [RR] = 2.85, <italic>p</italic> < .001), 95% confidence interval (CI) [1.51, 5.39], whereas CBT (RR = 1.55, <italic>p</italic> = .20), 95% CI [0.77, 3.10], and sertraline (RR = 1.27, <italic>p</italic> = .53), 95% CI [0.59, 2.73], did not significantly increase remission relative to placebo. These are the first findings demonstrating that a combination of CBT and a selective serotonin reuptake inhibitor, not monotherapy, is likely key for achieving remission in severe anxiety. CAMS was not powered to detect treatment efficacy after stratification by anxiety severity, so further research is needed regarding effective treatments in severe anxiety. Our main effect findings suggest youth with severe anxiety (especially social phobia), low socioeconomic status and obsessive-compulsive disorder benefit less from current first-line treatments relative to other anxious youth. ClinicalTrials.gov: NCT00052078.

Placebo Response in Pediatric Anxiety Disorders: Results from the Child/Adolescent Anxiety Multimodal Study.

The aim of this study is to identify predictors of pill placebo response and to characterize the temporal course of pill placebo response in anxious youth. Data from placebo-treated patients (N = 76) in the Child/Adolescent Anxiety Multimodal Study (CAMS), a multisite, randomized controlled trial that examined the efficacy of cognitive-behavioral therapy, sertraline, their combination, and placebo for the treatment of separation, generalized, and social anxiety disorders, were evaluated. Multiple linear regression models identified features associated with placebo response and models were confirmed with leave-one-out cross-validation. The likelihood of improvement in patients receiving pill placebo-over time-relative to improvement associated with active treatment was determined using probabilistic Bayesian analyses. Based on a categorical definition of response (Clinical Global Impressions-Improvement Scale score ≤2), nonresponders (n = 48), and pill placebo responders (n = 18) did not differ in age (p = 0.217), sex (p = 0.980), race (p = 0.743), or primary diagnosis (all ps > 0.659). In terms of change in anxiety symptoms, separation anxiety disorder and treatment expectation were associated with the degree of pill placebo response. Greater probability of placebo-related anxiety symptom improvement was observed early in the course of treatment (baseline to week 4, p < 0.0001). No significant change in the probability of placebo-related improvement was observed after week 4 (weeks 4-8, p = 0.07; weeks 8-12, p = 0.85), whereas the probability of improvement, in general, significantly increased week over week with active treatment. Pill placebo-related improvement occurs early in the course of treatment and both clinical factors and expectation predict this improvement. Additionally, probabilistic approaches may refine our understanding and prediction of pill placebo response.

Primary Pediatric Care Psychopharmacology: Focus on Medications for ADHD, Depression, and Anxiety

The evidence base for psychopharmacologic interventions in youth with depressive and anxiety disorders as well as attention/deficit hyperactivity disorder (ADHD) has dramatically increased over the past two decades. Psychopharmacologic interventions commonly utilized in the pediatric primary care setting-selective serotonin (norepinephrine) reuptake inhibitors (SSRIs/SSNRIs), stimulants and α2 agonists-are reviewed. General pharmacologic principles are summarized along with class-related side effects and tolerability concerns (e.g., suicidality and activation in antidepressant-treated youth as well as insomnia, irritability, anorexia in stimulant-treated pediatric patients). Selected landmark trials of antidepressant medications in youth with depressive disorders [Treatment of Adolescent Depression Study (TADS) and the Treatment of SSRI-Resistant Depression Study (TADS)] and anxiety disorders [Child/Adolescent Anxiety Multimodal Study (CAMS) and Child/Adolescent Anxiety Multimodal Extended Long-term Study (CAMELS)] are described in addition to the Multimodal Treatment of ADHD Study. Finally, available data are presented that are related to prediction of treatment outcomes in youth with depressive disorders, anxiety disorders, and ADHD.

Trajectories of change in youth anxiety during cognitive-behavior therapy.

To evaluate changes in the trajectory of youth anxiety following the introduction of specific cognitive-behavior therapy (CBT) components: relaxation training, cognitive restructuring, and exposure tasks. Four hundred eighty-eight youths ages 7-17 years (50% female; 74% ≤ 12 years) were randomly assigned to receive either CBT, sertraline (SRT), their combination (COMB), or pill placebo (PBO) as part of their participation in the Child/Adolescent Anxiety Multimodal Study (CAMS). Youths in the CBT conditions were evaluated weekly by therapists using the Clinical Global Impression Scale-Severity (CGI-S; Guy, 1976) and the Children's Global Assessment Scale (CGAS; Shaffer et al., 1983) and every 4 weeks by blind independent evaluators (IEs) using the Pediatric Anxiety Ratings Scale (PARS; RUPP Anxiety Study Group, 2002). Youths in SRT and PBO were included as controls. Longitudinal discontinuity analyses indicated that the introduction of both cognitive restructuring (e.g., changing self-talk) and exposure tasks significantly accelerated the rate of progress on measures of symptom severity and global functioning moving forward in treatment; the introduction of relaxation training had limited impact. Counter to expectations, no strategy altered the rate of progress in the specific domain of anxiety that it was intended to target (i.e., somatic symptoms, anxious self-talk, avoidance behavior). Findings support CBT theory and suggest that cognitive restructuring and exposure tasks each make substantial contributions to improvement in youth anxiety. Implications for future research are discussed. (PsycINFO Database Record

Child/Adolescent Anxiety Multimodal Study: Evaluating Safety

To evaluate the frequency of adverse events (AEs) across 4 treatment conditions in the Child/Adolescent Anxiety Multimodal Study (CAMS), and to compare the frequency of AEs between children and adolescents. Participants ages 7 to 17 years (mean= 10.7 years) meeting the DSM-IV criteria for 1 or more of the following disorders: separation anxiety disorder, generalized anxiety disorder, or social phobia were randomized (2:2:2:1) to cognitive-behavioral therapy (CBT, n= 139), sertraline (SRT, n= 133), a combination of both (COMB, n= 140), or pill placebo (PBO, n= 76). Data on AEs were collected via a standardized inquiry method plus a self-report Physical Symptom Checklist (PSC). There were no differences between the double-blinded conditions (SRT versus PBO) for total physical and psychiatric AEs or any individual physical or psychiatric AEs. The rates of total physical AEs were greater in the SRT-alone treatment condition when compared to CBT (p< .01) and COMB (p< .01). Moreover, those who received SRT alone reported higher rates of several physical AEs when compared to COMB and CBT. The rate of total psychiatric AEs was higher in children (≤12 years) across all arms (31.7% versus 23.1%, p< .05). Total PSC scores decreased over time, with no significant differences between treatment groups. The results support the tolerability/safety of selective serotonin reuptake inhibitor (SSRI) treatment for anxiety disorders even after adjusting for the number of reporting opportunities, leading to no differences in overall rates of AEs. Few differences occurred on specific items. Additional monitoring of psychiatric AEs is recommended in children (≤12 years). Clinical trial registration information-Child and Adolescent Anxiety Disorders (CAMS); http://clinicaltrials.gov; NCT00052078.

Anxiety Disorders in Caucasian and African American Children: A Comparison of Clinical Characteristics, Treatment Process Variables, and Treatment Outcomes.

This study examined racial differences in anxious youth using data from the Child/Adolescent Anxiety Multimodal Study (CAMS) [1]. Specifically, the study aims addressed whether African American (n=44) versus Caucasian (n=359) children varied on (1) baseline clinical characteristics, (2) treatment process variables, and (3) treatment outcomes. Participants were ages 7-17 and met DSM-IV-TR criteria for generalized anxiety disorder, social phobia, and/or separation anxiety disorder. Baseline data, as well as outcome data at 12 and 24weeks, were obtained by independent evaluators. Weekly treatment process variables were collected by therapists. Results indicated no racial differences on baseline clinical characteristics. However, African American participants attended fewer psychotherapy and pharmacotherapy sessions, and were rated by therapists as less involved and compliant, in addition to showing lower mastery of CBT. Once these and other demographic factors were accounted for, race was not a significant predictor of response, remission, or relapse. Implications of these findings suggest African American and Caucasian youth are more similar than different with respect to the manifestations of anxiety and differences in outcomes are likely due to treatment barriers to session attendance and therapist engagement.

Predictors and moderators of treatment response in childhood anxiety disorders: Results from the CAMS trial.

We sought to examine predictors and moderators of treatment outcomes among 488 youths ages 7-17 years (50% female; 74% ≤ 12 years) meeting Diagnostic and Statistical Manual of Mental Disorders (4th ed., text rev.; American Psychiatric Association, 2000) criteria for diagnoses of separation anxiety disorder, social phobia, or generalized anxiety disorder who were randomly assigned to receive either cognitive behavioral therapy (CBT), sertraline (SRT), their combination (COMB), or medication management with pill placebo (PBO) in the Child/Adolescent Anxiety Multimodal Study (CAMS). Six classes of predictor and moderator variables (22 variables) were identified from the literature and examined using continuous (Pediatric Anxiety Ratings Scale; PARS) and categorical (Clinical Global Impression Scale-Improvement; CGI-I) outcome measures. Three baseline variables predicted better outcomes (independent of treatment condition) on the PARS, including low anxiety severity (as measured by parents and independent evaluators) and caregiver strain. No baseline variables were found to predict Week 12 responder status (CGI-I). Participants' principal diagnosis moderated treatment outcomes but only on the PARS. No baseline variables were found to moderate treatment outcomes on Week 12 responder status (CGI-I). Overall, anxious children responded favorably to CAMS treatments. However, having more severe and impairing anxiety, greater caregiver strain, and a principal diagnosis of social phobia were associated with less favorable outcomes. Clinical implications of these findings are discussed.

24- and 36-Week Outcomes for the Child/Adolescent Anxiety Multimodal Study (CAMS)

We report active treatment group differences on response and remission rates and changes in anxiety severity at weeks 24 and 36 for the Child/Adolescent Anxiety Multimodal Study (CAMS). CAMS youth (N = 488; 74% ≤ 12 years of age) with DSM-IV separation, generalized, or social anxiety disorder were randomized to 12 weeks of cognitive-behavioral therapy (CBT), sertraline (SRT), CBT+SRT (COMB), or medication management/pill placebo (PBO). Responders attended 6 monthly booster sessions in their assigned treatment arm; youth in COMB and SRT continued on their medication throughout this period. Efficacy of COMB, SRT, and CBT (n = 412) was assessed at 24 and 36 weeks postrandomization. Youth randomized to PBO (n = 76) were offered active CAMS treatment if nonresponsive at week 12 or over follow-up and were not included here. Independent evaluators blind to study condition assessed anxiety severity, functioning, and treatment response. Concomitant treatments were allowed but monitored over follow-up. The majority (>80%) of acute responders maintained positive response at both weeks 24 and 36. Consistent with acute outcomes, COMB maintained advantage over CBT and SRT, which did not differ, on dimensional outcomes; the 3 treatments did not differ on most categorical outcomes over follow-up. Compared to COMB and CBT, youth in SRT obtained more concomitant psychosocial treatments, whereas those in SRT and CBT obtained more concomitant combined (medication plus psychosocial) treatment. COMB maintained advantage over CBT and SRT on some measures over follow-up, whereas the 2 monotherapies remained indistinguishable. The observed convergence of COMB and monotherapy may be related to greater use of concomitant treatment during follow-up among youth receiving the monotherapies, although other explanations are possible. Although outcomes were variable, most CAMS-treated youth experienced sustained treatment benefit. Clinical trial registration information-Child and Adolescent Anxiety Disorders (CAMS); URL: http://clinicaltrials.gov. Unique identifier: NCT00052078.