Developmental Differences in Functioning in Youth With Social Phobia.

Social phobia (SoP) in youth may manifest differently across development as parent involvement in their social lives changes and social and academic expectations increase. This cross-sectional study investigated whether self-reported and parent-reported functioning in youth with SoP changes with age in social, academic, and home/family domains. Baseline anxiety impairment data from 488 treatment-seeking anxiety-disordered youth (ages 7-17, N = 400 with a SoP diagnosis) and their parents were gathered using the Child Anxiety Impact Scale and were analyzed using generalized estimating equations. According to youth with SoP and their parents, overall difficulties, social difficulties, and academic difficulties increased with age, even when controlling for SoP severity. These effects significantly differed for youth with anxiety disorders other than SoP. Adolescents may avoid social situations as parental involvement in their social lives decreases, and their withdrawn behavior may result in increasing difficulty in the social domain. Their avoidance of class participation and oral presentations may increasingly impact their academic performance as school becomes more demanding. Implications are discussed for the early detection and intervention of SoP to prevent increased impairment over the course of development.

Sleep-Related Problems and the Effects of Anxiety Treatment in Children and Adolescents.

This study examined (a) demographic and clinical characteristics associated with sleep-related problems (SRPs) among youth with anxiety disorders, and (b) the impact of anxiety treatment: cognitive-behavioral therapy (CBT; Coping Cat), medication (sertraline), their combination, and pill placebo on SRPs. Youth (N = 488, ages 7-17, 50% female, 79% White) with a principal diagnosis of generalized anxiety disorder, separation anxiety disorder, or social phobia participated. SRPs were reported by parents and youth. Findings differed by informant and by type of SRP, with evidence that SRPs are associated with age, anxiety severity, externalizing problems, functional impairment, and family burden at pretreatment. Anxiety treatment reduced SRPs; effect sizes were small to medium. Reductions in parent-reported separation-related sleep difficulties were significantly greater in active treatment than in the placebo condition, with the greatest reductions reported by parents of youth whose active treatment was multimodal or included sertraline. Youth whose anxiety treatment involved CBT reported significantly greater decreases in dysregulated sleep (e.g., sleeplessness). Both CBT for anxiety and sertraline appear to be somewhat effective in reducing SRPs, and multimodal treatment may be preferable depending on the symptom presentation. To inform practice, future research should examine a broad range of SRPs, incorporate objective measures of sleep, and evaluate the impact of behavioral strategies that directly target SRPs in youth with anxiety disorders.

Adaptive Treatment Strategies in Youth Mental Health: A Commentary on Advantages, Challenges, and Potential Directions.

This commentary underscores the importance and potential of the research approaches and intervention strategies described in the JCCAP special issue on the Science of Adaptive Treatment Strategies in Child and Adolescent Mental Health for addressing the widely observed heterogeneity in response to even our most promising research-informed interventions. First, the commentary briefly summarizes the advantages of these approaches and highlights how these programs of research are responsive to widely agreed-upon calls for more personalized, prescriptive interventions. Next, the commentary briefly discusses key common challenges and gaps in our knowledge that might be addressed to advance the development, testing, and implementation of adaptive intervention strategies. For example, research to identify robust moderators that might serve as potential tailoring variables for initial assignment and sequencing of interventions, efforts to operationalize surrogate endpoints for early identification of individuals who are unlikely to respond to first-line interventions, and research that helps define what constitutes an adequate exposure (i.e., dose) or response threshold (e.g., response that suggests the need to intensify, switch, or augment interventions) would inform decision rules for adaptive algorithms. The commentary concludes with a discussion of potential strategies and current initiatives that might ultimately help facilitate research on more targeted, prescriptive approaches to intervening, including efforts to encourage investigators to use common data elements, to share and integrate data across trials, and to employ a more mechanism-based approach to intervention development and testing.

Treatment Outcomes in Anxious Youth with and without Comorbid ADHD in the CAMS.

The purpose of this study is to examine the influence of Attention-Deficit/Hyperactivity Disorder (ADHD), independent of Oppositional Defiant Disorder (ODD), on acute treatment response, remission rates and maintenance of gains at 6-month follow-up in anxious youth (ages 7-17, 76% Caucasian, 52% female) who received cognitive-behavioral therapy (CBT) alone, pharmacotherapy alone, the combination of CBT and pharmacotherapy or placebo pill in the Child/Adolescent Multimodal Study. Treatment response was defined as independent evaluator rated meaningful improvement in anxiety. Remission was operationalized as the absence of targeted anxiety disorders. ADHD and ODD were examined as moderators of outcomes at a diagnostic level. In the CBT group only, an ADHD diagnosis predicted poorer immediate treatment response and remission rates. However, these associations were not obtained for the pharmacotherapy groups. Participants with comorbid ODD were not less likely to achieve acute treatment response and remission rates than their counterparts across treatment conditions. Due to small sample size of the comorbid subgroups, our analyses must be considered preliminary. Nevertheless, our initial findings suggest further exploration of the separate roles of ADHD and ODD are worth pursuing, as they may be differentially associated with treatment outcomes in anxious youth treated with CBT but not youth treated with pharmacotherapy. If confirmed, findings may indicate that anxious youth with comorbid ADHD are less likely to benefit from CBT strategies alone and raise the possibility that these youth need adjunctive pharmacotherapy or psychosocial interventions.

Parental anxiety as a predictor of medication and CBT response for anxious youth.

The aim of this investigation was to evaluate how parental anxiety predicted change in pediatric anxiety symptoms across four different interventions: cognitive-behavioral therapy, medication (sertraline; SRT), their combination (COMB), and pill placebo. Participants were 488 youths (ages 7-17) with separation anxiety disorder, generalized anxiety disorder, and/or social phobia and their primary caregivers. Latent growth curve modeling assessed how pre-treatment parental trait anxiety symptoms predicted trajectories of youth anxiety symptom change across 12 weeks of treatment at four time points. Interactions between parental anxiety and treatment condition were tested. Parental anxiety was not associated with youth's pre-treatment anxiety symptom severity. Controlling for parental trait anxiety, youth depressive symptoms, and youth age, youths who received COMB benefitted most. Counter to expectations, parental anxiety influenced youth anxiety symptom trajectory only within the SRT condition, whereas parental anxiety was not significantly associated with youth anxiety trajectories in the other treatment conditions. Specifically, within the SRT condition, higher levels of parental anxiety predicted a faster and greater reduction in youth anxiety over the acute treatment period compared to youths in the SRT condition whose parents had lower anxiety levels. While all active treatments produced favorable outcomes, results provide insight regarding the treatment-specific influence of parental anxiety on the time course of symptom change.

Assessing anxiety in youth with the multidimensional anxiety scale for children.

The present study examined the psychometric properties, including discriminant validity and clinical utility, of the youth self-report and parent-report forms of the Multidimensional Anxiety Scale for Children (MASC) among youth with anxiety disorders. The sample included parents and youth (N = 488, 49.6% male) ages 7 to 17 who participated in the Child/Adolescent Anxiety Multimodal Study. Although the typical low agreement between parent and youth self-reports was found, the MASC evidenced good internal reliability across MASC subscales and informants. The main MASC subscales (i.e., Physical Symptoms, Harm Avoidance, Social Anxiety, and Separation/Panic) were examined. The Social Anxiety and Separation/Panic subscales were found to be significantly predictive of the presence and severity of social phobia and separation anxiety disorder, respectively. Using multiple informants improved the accuracy of prediction. The MASC subscales demonstrated good psychometric properties and clinical utilities in identifying youth with anxiety disorders.

Somatic complaints in anxious youth.

This study examined (a) demographic and clinical characteristics associated with physical symptoms in anxiety-disordered youth and (b) the impact of cognitive-behavioral therapy (Coping Cat), medication (sertraline), their combination, and pill placebo on physical symptoms. Youth (N = 488, ages 7-17 years) with a principal diagnosis of generalized anxiety disorder, separation anxiety disorder, or social phobia participated as part of a multi-site, randomized controlled trial and received treatment delivered over 12 weeks. Diagnostic status, symptom severity, and impairment were assessed at baseline and week 12. The total number and severity of physical symptoms was associated with age, principal diagnosis, anxiety severity, impairment, and the presence of comorbid internalizing disorders. Common somatic complaints were headaches, stomachaches, head cold or sniffles, sleeplessness, and feeling drowsy or too sleepy. Physical symptoms decreased over the course of treatment, and were unrelated to treatment condition. Clinical implications and directions for future research are discussed (ClinicalTrials.gov number, NCT00052078).

National Institute of Mental Health Support for Cognitive Treatment Development in Schizophrenia: A Narrative Review.

For several decades the National Institute of Mental Health (NIMH) has supported basic and translational research into cognitive impairment in schizophrenia. This article describes the Institute's ongoing commitment to cognitive assessment and intervention research, as reflected by three signature initiatives-Measurement and Treatment Research to Improve Cognition in Schizophrenia; Cognitive Neuroscience Treatment Research to Improve Cognition in Schizophrenia; and Research Domain Criteria-and related funding announcements that span basic experimental studies, efficacy and comparative effectiveness trials, and implementation research designed to promote cognitive healthcare in real-world treatment settings. We discuss how trends in science and public health policy since the early 2000s have influenced NIMH treatment development activities, resulting in greater attention to (1) inclusive teams that reflect end-user perspectives on the utility of proposed studies; (2) measurement of discrete neurocognitive processes to inform targeted interventions; (3) clinical trials that produce useful information about putative illness mechanisms, promising treatment targets, and downstream clinical effects; and (4) "productive urgency" in pursuing feasible and effective cognitive interventions for psychosis. Programs employing these principles have catalyzed cognitive measurement, drug development, and behavioral intervention approaches that aim to improve neurocognition and community functioning among persons with schizophrenia. NIMH will maintain support for innovative and impactful investigator-initiated research that advances patient-centered, clinically effective, and continuously improving cognitive health care for persons with psychotic disorders.

Therapist Factors and Outcomes in CBT for Anxiety in Youth.

This study examined the relationship between therapist factors and child outcomes in anxious youth who received cognitive-behavioral therapy (CBT) as part of the Child-Adolescent Anxiety Multimodal Study (CAMS). Of the 488 youth who participated in the CAMS project, 279 were randomly assigned to one of the CBT conditions (CBT only or CBT plus sertraline). Participants included youth (ages 7-17; M = 10.76) who met criteria for a principal anxiety disorder. Therapists included 38 cognitive-behavioral therapists. Therapist style, treatment integrity, and therapist experience were examined in relation to child outcome. Child outcome was measured via child, parent, and independent evaluator report. Therapists who were more collaborative and empathic, followed the treatment manual, and implemented it in a developmentally appropriate way had youth with better treatment outcomes. Therapist "coach" style was a significant predictor of child-reported outcome, with the collaborative "coach" style predicting fewer child-reported symptoms. Higher levels of therapist prior clinical experience and lower levels of prior anxiety-specific experience were significant predictors of better treatment outcome. Findings suggest that although all therapists used the same manual-guided treatment, therapist style, experience, and clinical skills were related to differences in child outcome. Clinical implications and recommendations for future research are discussed.

Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety.

BACKGROUND: Anxiety disorders are common psychiatric conditions affecting children and adolescents. Although cognitive behavioral therapy and selective serotonin-reuptake inhibitors have shown efficacy in treating these disorders, little is known about their relative or combined efficacy. METHODS: In this randomized, controlled trial, we assigned 488 children between the ages of 7 and 17 years who had a primary diagnosis of separation anxiety disorder, generalized anxiety disorder, or social phobia to receive 14 sessions of cognitive behavioral therapy, sertraline (at a dose of up to 200 mg per day), a combination of sertraline and cognitive behavioral therapy, or a placebo drug for 12 weeks in a 2:2:2:1 ratio. We administered categorical and dimensional ratings of anxiety severity and impairment at baseline and at weeks 4, 8, and 12. RESULTS: The percentages of children who were rated as very much or much improved on the Clinician Global Impression-Improvement scale were 80.7% for combination therapy (P<0.001), 59.7% for cognitive behavioral therapy (P<0.001), and 54.9% for sertraline (P<0.001); all therapies were superior to placebo (23.7%). Combination therapy was superior to both monotherapies (P<0.001). Results on the Pediatric Anxiety Rating Scale documented a similar magnitude and pattern of response; combination therapy had a greater response than cognitive behavioral therapy, which was equivalent to sertraline, and all therapies were superior to placebo. Adverse events, including suicidal and homicidal ideation, were no more frequent in the sertraline group than in the placebo group. No child attempted suicide. There was less insomnia, fatigue, sedation, and restlessness associated with cognitive behavioral therapy than with sertraline. CONCLUSIONS: Both cognitive behavioral therapy and sertraline reduced the severity of anxiety in children with anxiety disorders; a combination of the two therapies had a superior response rate. (ClinicalTrials.gov number, NCT00052078.)

Integrating statistical and clinical research elements in intervention-related grant applications: summary from an NIMH workshop.

OBJECTIVE: The authors summarize points for consideration generated in a National Institute of Mental Health (NIMH) workshop convened to provide an opportunity for reviewers from different disciplines-specifically clinical researchers and statisticians-to discuss how their differing and complementary expertise can be well integrated in the review of intervention-related grant applications. METHODS: A 1-day workshop was convened in October, 2004. The workshop featured panel presentations on key topics followed by interactive discussion. This article summarizes the workshop and subsequent discussions, which centered on topics including weighting the statistics/data analysis elements of an application in the assessment of the application's overall merit; the level of statistical sophistication appropriate to different stages of research and for different funding mechanisms; some key considerations in the design and analysis portions of applications; appropriate statistical methods for addressing essential questions posed by an application; and the role of the statistician in the application's development, study conduct, and interpretation and dissemination of results. RESULTS: A number of key elements crucial to the construction and review of grant applications were identified. It was acknowledged that intervention-related studies unavoidably involve trade-offs. Reviewers are helped when applications acknowledge such trade-offs and provide good rationale for their choices. Clear linkage among the design, aims, hypotheses, and data analysis plan and avoidance of disconnections among these elements also strengthens applications. CONCLUSION: The authors identify multiple points to consider when constructing intervention-related grant applications. The points are presented here as questions and do not reflect institute policy or comprise a list of best practices, but rather represent points for consideration.

Trends in Children's Mental Health Services Research Funding: Response to Hoagwood and Colleagues' Commentary.

In their recent JAACAP Commentary, Hoagwood et al.1 examined data extracted from the National Institutes of Health Research Portfolio Online Reporting Tools (RePORT) and concluded there has been a decrease in National Institute of Mental Health (NIMH) funding for child and adolescent services and intervention research during the 10-year period from 2005 to 2015. They eloquently argued for the importance of research that can guide practice and inform the organization and delivery of children's mental health services in the current context of unmet need and the state of mental health service delivery.

Secondary Outcomes From the Child/Adolescent Anxiety Multimodal Study: Implications for Clinical Practice.

BACKGROUND: Controlled evaluations comparing medication, cognitive-behavioral therapy (CBT), and their combination in the treatment of youth anxiety have predominantly focused on global ratings by independent evaluators. Such ratings are resource-intensive, may be of limited generalizability, and do not directly inform our understanding of treatment responses from the perspective of treated families. We examined outcomes from the perspective of treated youth and parents in the Child/Adolescent Anxiety Multimodal Study (CAMS). METHODS: Participants (N=488; ages 7-17 years) who had a primary diagnosis of separation, social, and/or generalized anxiety disorder were randomly assigned to a treatment condition in the CAMS trial. Linear mixed-effects and ANCOVA models examined parent- and youth-reported anxiety symptoms, impact of anxiety, broader internalizing and externalizing psychopathology, depressive symptoms, and family burden throughout the 12-week acute treatment phase and 6-month follow-up. RESULTS: At week 12, combination treatment showed superiority over placebo, sertraline, and CBT with regard to parent-reported youth anxiety symptoms, and sertraline and CBT as monotherapies showed superiority over placebo with regard to parent-reported youth anxiety. Combination therapy and sertraline also showed week 12 superiority over placebo with regard to parent-reported internalizing psychopathology, and superiority over placebo and CBT with regard to parent-reported impact of anxiety, family burden, and youth depressive symptoms. By week 36, parent reports of many youth outcomes were comparable across active conditions. Youth measures tracked parent measures on many outcomes. CONCLUSIONS: Findings were drawn on brief, readily available questionnaires that in conjunction with clinician measures can inform patient-centered care and collaborative decision-making.Trial Registry Name: Child and Adolescent Anxiety Disorders (CAMS)Registry identification number: NCT00052078Registry URL: https://www.clinicaltrials.gov/ct2/show/NCT00052078.

Contextual emotion-regulation therapy for childhood depression: description and pilot testing of a new intervention.

OBJECTIVE: To pilot test the acceptability and efficacy of contextual emotion-regulation therapy (CERT), a new, developmentally appropriate intervention for childhood depression, which focuses on the self-regulation of dysphoria. METHOD: Two samples of convenience (n = 29, n = 2) served to verify some CERT constructs; it was then operationalized in a treatment manual. To pilot test CERT, 20 children (ages 7-12; 35% girls) with DSM dysthymic disorder (mean duration 24.4 months) entered an open, 30-session, 10-month, 4-phase trial, with 6- and 12-month follow-up. Assessments included independent clinical evaluations and self-rated questionnaires. RESULTS: Fifteen children completed theraphy, four were administratively terminated and one dropped out. Completers did not clinically differ from the rest, but they were more likely to have better educated and less depressed mothers and intact families. At the end of treatment, 53% of the completers had full and 13% partial remission of dysthymia (remission from superimposed major depression was 80%). By 6- and 12-month follow-up, 79% and 92% had full remission of dysthymia (p < 0.0001). Self-reported depressive and anxiety symptoms significantly declined by the end of treatment (p < .001) and remained so throughout follow-up. CONCLUSIONS: CERT enables clinicians to "match" the intervention to children's emotion regulatory needs and symptoms and was readily accepted by families. The promising results suggest the need for a randomized trial.

Mediators of change in the Child/Adolescent Anxiety Multimodal Treatment Study.

OBJECTIVE: Test changes in (a) coping efficacy and (b) anxious self-talk as potential mediators of treatment gains at 3-month follow-up in the Child/Adolescent Anxiety Multimodal Treatment Study (CAMS). METHOD: Participants were 488 youth (ages 7-17; 50.4% male) randomized to cognitive-behavioral therapy (CBT; Coping cat program), pharmacotherapy (sertraline), their combination, or pill placebo. Participants met Diagnostic and Statistical Manual for Mental Disorders-Fourth Edition (DSM-IV) criteria for generalized anxiety disorder, social phobia, and/or separation anxiety disorder. Coping efficacy (reported ability to manage anxiety provoking situations) was measured by youth and parent reports on the Coping Questionnaire, and anxious self-talk was measured by youth report on the Negative Affectivity Self-Statement Questionnaire. Outcome was measured using the Pediatric Anxiety Rating Scale (completed by Independent Evaluators blind to condition). For temporal precedence, residualized treatment gains were assessed at 3-month follow-up. RESULTS: Residualized gains in coping efficacy mediated gains in the CBT, sertraline, and combination conditions. In the combination condition, some unique effect of treatment remained. Treatment assignment was not associated with a reduction in anxious self-talk, nor did anxious self-talk predict changes in anxiety symptoms. CONCLUSIONS: The findings suggest that improvements in coping efficacy are a mediator of treatment gains. Anxious self-talk did not emerge as a mediator.

Parental psychopathology and treatment outcome for anxious youth: roles of family functioning and caregiver strain.

OBJECTIVE: Research has examined the effects of parental psychopathology, family functioning, and caregiver strain on treatment response in anxious youths. Although these variables have shown individual links to youth treatment response, theoretical models for their combined effects remain unexplored. This study tested the hypothesis that improvements in family functioning and reductions in caregiver strain explained the effects of parental psychopathology on youth treatment outcome in an anxiety treatment trial. METHOD: A multiple mediation technique was used to test the proposed model across independent evaluator (IE), parent, and youth informants in 488 youths, aged 7-17 years (50% female; mean age = 10.7) meeting Diagnostic and Statistical Manual of Mental Disorders criteria for social phobia, separation anxiety, and/or generalized anxiety disorder. Youths were randomized to receive 12 weeks of cognitive-behavioral treatment (Coping Cat), medication (sertraline), their combination, or a pill placebo. At pre- and posttreatment, parents completed self-report measures of global psychopathology symptoms, family functioning, and caregiver strain; parents, youths, and IEs rated youths' anxiety symptom severity. RESULTS: Changes in family functioning and caregiver strain jointly explained relations between parental psychopathology and reductions in youth anxiety. Specifically, across IE and parent informants, families with higher pretreatment parental psychopathology showed more improvement in family functioning and caregiver strain, which in turn predicted greater youth anxiety reductions. Further, higher pretreatment parental psychopathology predicted greater caregiver strain reductions and, in turn, greater youth anxiety reductions, based on youths' reports of their own anxiety. CONCLUSIONS: Findings suggest that improvements in family functioning and reductions in caregiver strain can influence treatment outcomes for anxious youths, especially among youths with more distressed parents.

Child/Adolescent anxiety multimodal study: evaluating safety.

OBJECTIVE: 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. METHOD: 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). RESULTS: 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. CONCLUSION: 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.

Predicting Anxiety Diagnoses and Severity with the CBCL-A: Improvement Relative to Other CBCL Scales?

The Child Behavior Checklist (CBCL) is a widely used parent-report of child and adolescent behavior. We examined the ability of the CBCL-A scale, a previously published subset of CBCL items, to predict the presence of generalized anxiety disorder (GAD), separation anxiety disorder (SAD), and social phobia (SoP), as well as anxiety severity, among 488 youth randomized in the Child Anxiety Multimodal Study (CAMS). We predicted that the CBCL-A's unique inclusion of items related to somatic symptoms would better identify anxiety disorder and severity than other CBCL scales, given that somatic complaints are often key features of anxiety among youth. Results support the use of the anxiety-based CBCL subscales as first-line screeners for generally elevated symptoms of anxiety, rather than tools to identify specific anxiety disorders. Although somatic symptoms are often reported and included in diagnostic criteria for certain anxiety disorders (e.g., SAD, GAD), the unique combination of somatic and non-somatic symptoms for the CBCL-A subscale did not increase its ability to consistently predict the presence of specific anxiety disorders.