Golda S. Ginsburg

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.)

Treating anxiety disorders in children with group cognitive-behaviorial therapy: a randomized clinical trial.

A randomized clinical trial evaluated the therapeutic efficacy of group cognitive-behavioral therapy (GCBT) versus a wait-list control (WLC) condition to treat anxiety disorders in children. Results indicated that GCBT, with concurrent parent sessions, was highly efficacious in producing and maintaining treatment gains. Children in GCBT showed substantial improvement on all the main outcome measures, and these gains were maintained at 3-, 6-, and 12-month follow-ups. Children in the WLC condition did not show improvements from the pre- to the postwait assessment point. These findings are discussed in terms of the need to continue to advance the development of practical, as well as conceptual, knowledge of efficacious treatment for anxiety disorders in children.

Behavior therapy for children with Tourette disorder: a randomized controlled trial.

CONTEXT Tourette disorder is a chronic and typically impairing childhood-onset neurologic condition. Antipsychotic medications, the first-line treatments for moderate to severe tics, are often associated with adverse effects. Behavioral interventions, although promising, have not been evaluated in large-scale controlled trials. OBJECTIVE To determine the efficacy of a comprehensive behavioral intervention for reducing tic severity in children and adolescents. DESIGN, SETTING, AND PARTICIPANTS Randomized, observer-blind, controlled trial of 126 children recruited from December 2004 through May 2007 and aged 9 through 17 years, with impairing Tourette or chronic tic disorder as a primary diagnosis, randomly assigned to 8 sessions during 10 weeks of behavior therapy (n = 61) or a control treatment consisting of supportive therapy and education (n = 65). Responders received 3 monthly booster treatment sessions and were reassessed at 3 and 6 months following treatment. INTERVENTION Comprehensive behavioral intervention. MAIN OUTCOME MEASURES Yale Global Tic Severity Scale (range 0-50, score >15 indicating clinically significant tics) and Clinical Global Impressions-Improvement Scale (range 1 [very much improved] to 8 [very much worse]). RESULTS Behavioral intervention led to a significantly greater decrease on the Yale Global Tic Severity Scale (24.7 [95% confidence interval {CI}, 23.1-26.3] to 17.1 [95% CI, 15.1-19.1]) from baseline to end point compared with the control treatment (24.6 [95% CI, 23.2-26.0] to 21.1 [95% CI, 19.2-23.0]) (P < .001; difference between groups, 4.1; 95% CI, 2.0-6.2) (effect size = 0.68). Significantly more children receiving behavioral intervention compared with those in the control group were rated as being very much improved or much improved on the Clinical Global Impressions-Improvement scale (52.5% vs 18.5%, respectively; P < .001; number needed to treat = 3). Attrition was low (12/126, or 9.5%); tic worsening was reported by 4% of children (5/126). Treatment gains were durable, with 87% of available responders to behavior therapy exhibiting continued benefit 6 months following treatment. CONCLUSION A comprehensive behavioral intervention, compared with supportive therapy and education, resulted in greater improvement in symptom severity among children with Tourette and chronic tic disorder. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00218777.

Contingency management, self-control, and education support in the treatment of childhood phobic disorders : A randomized Clinical Trial

This study evaluated the relative efficacy of an exposure-based contingency management (CM) treatment condition and an exposure-based cognitive self-control (SC) treatment condition relative to an education support (ES) control condition for treating children with phobic disorders. Eighty-one children and their parents completed a 10-week treatment program in which children and parents were seen in separate treatment sessions with the therapist, followed by a brief conjoint meeting. Children in both the CM and SC conditions showed substantial improvement on all of the outcome measures. These gains were maintained at 3-, 6-, and 12-month follow-ups. Interestingly, children in the ES condition also showed comparable improvements at posttreatment and at 3-, 6-, and 12-month follow-ups. Implications of the findings are discussed with respect to knowledge development and clinical practice.

Social anxiety in children with anxiety disorders : Relation with social and emotional functioning

Investigated the psychometric properties of the Social Anxiety Scale for children-Revised (SASC-R) as well as relations between social anxiety and childrens social and emotional functioning. Participants were a clinic sample of children, ages 6–11 with anxiety disorders (N = 154) who completed the SASC-R. For a subset of these children, parent ratings of social skills, and self-ratings of perceived competence and peer interactions were also obtained. Factor analysis of the SASC-R supported the original three-factor solution and internal consistencies were in the acceptable range. Among children with simple phobia, scores on the SASC-R differentiated those with and without a comorbid social-based anxiety disorder. Social anxiety was also associated with impairments in social and emotional functioning. Specifically, highly socially anxious children reported low levels of social acceptance and global self-esteem and more negative peer interactions. Girls with high levels of social anxiety were also rated by parents as having poor social skills, particularly in the areas of assertive and responsible social behavior.

Child/Adolescent Anxiety Multimodal Study (CAMS): rationale, design, and methods

ObjectiveTo present the design, methods, and rationale of the Child/Adolescent Anxiety Multimodal Study (CAMS), a recently completed federally-funded, multi-site, randomized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy (CBT), sertraline (SRT), and their combination (COMB) against pill placebo (PBO) for the treatment of separation anxiety disorder (SAD), generalized anxiety disorder (GAD) and social phobia (SoP) in children and adolescents.MethodsFollowing a brief review of the acute outcomes of the CAMS trial, as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders, the design and methods of the CAMS trial are described.ResultsCAMS was a six-year, six-site, randomized controlled trial. Four hundred eighty-eight (N = 488) children and adolescents (ages 7-17 years) with DSM-IV-TR diagnoses of SAD, GAD, or SoP were randomly assigned to one of four treatment conditions: CBT, SRT, COMB, or PBO. Assessments of anxiety symptoms, safety, and functional outcomes, as well as putative mediators and moderators of treatment response were completed in a multi-measure, multi-informant fashion. Manual-based therapies, trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity. A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance.ConclusionsCAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls. CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidenced-based psychosocial (CBT) and pharmacologic (SSRI) treatments to date for the most commonly occurring pediatric anxiety disorders. Primary and secondary results of CAMS will hold important implications for informing practice-relevant decisions regarding the initial treatment of youth with anxiety disorders.Trial registrationClinicalTrials.gov NCT00052078.

Clinical characteristics of anxiety disordered youth.

Reports the characteristics of a large, representative sample of treatment-seeking anxious youth (N=488). Participants, aged 7-17 years (mean 10.7 years), had a principal DSM-IV diagnosis of separation anxiety disorder (SAD), generalized anxiety disorder (GAD), or social phobia (SP). Although youth with a co-primary diagnosis for which a different disorder-specific treatment would be indicated (e.g., major depressive disorder, substance abuse) were not included, there were few other exclusion criteria. Participants and their parent/guardian underwent an extensive baseline assessment using a broad array of measures capturing diagnostic status, anxiety symptoms and severity, and areas of functional impairment. Means and standard deviations of the measures of psychopathology and data on diagnostic status are provided. The sample had moderate to severe anxiety disorder and was highly comorbid, with 55.3% of participants meeting criteria for at least one non-targeted DSM-IV disorder. Anxiety disorders in youth often do not present as a single/focused disorder: such disorders in youth overlap in symptoms and are highly comorbid among themselves.

Family-based treatment of childhood anxiety disorders

Recently attention has turned to family involvement in the treatment of childhood anxiety disorders. Theoretical models and research on parenting behaviour have identified specific targets for family intervention. A growing number of family-based treatment studies targeting these parenting behaviours and interactions suggest that this approach is effective. A review of the targets of treatment and intervention strategies are described in detail.

Remission after Acute Treatment in Children and Adolescents with Anxiety Disorders: Findings from the CAMS.

OBJECTIVE To report on remission rates in anxious youth who participated in the Child/Adolescent Anxiety Multimodal Study (CAMS). The CAMS, a multisite clinical trial, randomized 488 children and adolescents (ages 7-17 years; 79% Caucasian; 50% female) with separation, social, and/or generalized anxiety disorder to a 12-week treatment of sertraline (SRT), cognitive behavioral therapy (CBT), their combination (COMB), or clinical management with pill placebo (PBO). METHOD The primary definition of remission was loss of all study-entry anxiety disorder diagnoses; additional definitions of remission were used. All outcomes were rated by independent evaluators blind to treatment assignment. Predictors of remission were also examined. RESULTS Remission rates after 12 weeks of treatment ranged from 46% to 68% for COMB, 34% to 46% for SRT, 20% to 46% for CBT, and 15% to 27% for PBO. Rates of remission (i.e., achieving a nearly symptom-free state) were significantly lower than rates of response (i.e., achieving a clinically meaningful improvement relative to baseline) for the entire sample. Youth who received COMB had significantly higher rates of remission compared to all other treatment groups. Both monotherapies had higher remission rates compared to PBO, but rates were not different from each other. Predictors of remission were younger age, nonminority status, lower baseline anxiety severity, absence of other internalizing disorders (e.g., anxiety, depression), and absence of social phobia. CONCLUSIONS For the majority of children, some symptoms of anxiety persisted, even among those showing improvement after 12 weeks of treatment, suggesting a need to augment or extend current treatments for some children.

Anxiety Disorders in Children: Family Matters.

Accumulating evidence indicates that family/parenting behaviors are associated with the etiology of anxiety disorders in children. This article critically reviews what is known about how family/parenting behaviors have been measured in this literature and presents findings from studies examining the relation between family/parenting constructs and anxiety disorders in children. We review the role of family involvement in the treatment of anxiety disorders in children and conclude with avenues of future research.