Walkup, J., Albano, A. M., Piacentini, J., Birmaher, B., Compton, S., Sherrill, J., Ginsburg, G. S., Rynn, M. A., McCracken, J., Waslick, B., Iyengar, S., March, J. S., & Kendall, P. C. (2008). Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety. New England Journal of Medicine, 359, 2753-2766. https://doi.org/10.1056/NEJMoa0804633

Type of Study: Randomized controlled trial
Number of Participants: 488

Population:

• Age — 7-17 years
• Race/Ethnicity — 78.9% White, 12.1% Hispanic, 9% Black, 2.5% Asian, 1.2% American Indian, 0.4% Pacific Islander, and 8.0% Other
• Gender — 50.4% Male and 49.6% Female
• Status — Participants were children and adolescents with anxiety disorders.

Location/Institution: New York State Psychiatric Institute–Columbia University Medical Center–New York University; Duke University Medical Center; Johns Hopkins Medical Institutions; Temple University–University of Pennsylvania; University of California, Los Angeles; and Western Psychiatric Institute and Clinic–University of Pittsburgh Medical Center

Summary: (To include basic study design, measures, results, and notable limitations)
This study evaluates the relative efficacy of Coping Cat [now called C.A.T. Project for youth aged 12-18] which is a cognitive-behavioral therapy, sertraline, a combination of the two therapies, and a placebo drug. Participants were randomly assigned to receive one of the four conditions for 12 weeks. Measure used was the Anxiety Disorders Interview Schedule for DSM-IV-TR, Child Version, 20; Clinical Global Impression–Improvement Scale; and the Pediatric Anxiety Rating Scale. Results indicated that both Coping Cat and sertraline reduced the severity of anxiety in children with anxiety disorders; a combination of the two therapies had a superior response rate. Limitations include the exclusion of children and teens with major depression and pervasive developmental disorders may have limited the generalizability of the results to these populations.

Length of controlled postintervention follow-up: None.

Ginsburg, G. S., Kendall, P. C., Sakolsky, D., Compton, S. N., Piacentini, J., Albano, A. M., Walkup, J. T., Sherrill, J., Coffey, K. A., Rynn, M. A., Keeton, C. P., McCracken, J. T., Bergman, L., Iyengar, S., Birmaher, B., & March, J. (2011). Remission after acute treatment in children and adolescents with anxiety disorders: Findings from the CAMS. Journal of Consulting and Clinical Psychology, 79(6), 806-813. https://doi.org/10.1037/a0025933

Type of Study: Randomized controlled trial
Number of Participants: 488

Population:

• Age — 7-17 years
• Race/Ethnicity — 78.9% White, 12.1% Hispanic, 9% Black, 2.5% Asian, 1.2% American Indian, 0.4% Pacific Islander, and 8.0% Other
• Gender — 50.4 % Male and 49.6% Female
• Status — Participants were children and adolescents with anxiety disorders.

Location/Institution: New York State Psychiatric Institute–Columbia University Medical Center–New York University; Duke University Medical Center; Johns Hopkins Medical Institutions; Temple University–University of Pennsylvania; University of California, Los Angeles; and Western Psychiatric Institute and Clinic–University of Pittsburgh Medical Center

Summary: (To include basic study design, measures, results, and notable limitations)
This study used the same sample as Walkup et al. (2008). It reports on remission rates in anxious youth who were randomly assigned to a 12-week treatment of sertraline (SRT), Coping Cat [now called C.A.T. Project for youth aged 12-18] which is a cognitive-behavioral therapy, 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 Coping Cat, and 15% to 27% for PBO. 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. Limitations include the lack of follow-up data.

Length of controlled postintervention follow-up: None.

Cummings, C. M., Caporino, N. E., Settipani, C. A., Read, K. L., Compton, S. N., March, J., Sherrill, J., Piacentini, J., McCracken, J., Walkup, J. T., Ginsburg, G., Albano, A. M., Rynn, M., Birmaher, B., Sakolsky, D., Gosch, E., Keeton, C., & Kendall, P.  (2013). The therapeutic relationship in cognitive-behavioral therapy and pharmacotherapy for anxious youth. Journal of Consulting and Clinical Psychology, 81(5), 859-864. https://doi.org/10.1037/a0033294

Type of Study: Randomized controlled trial
Number of Participants: 488

Population:

• Age — 7-17 years
• Race/Ethnicity — 81.6% White, 8.7% African American, 8% Hispanic, 3.1% Asian, and 6.6% Other
• Gender — 49.6% Female
• Status — Participants were children with a primary diagnosis of separation or generalized anxiety disorder or social phobia.

Location/Institution: Not specified

Summary: (To include basic study design, measures, results, and notable limitations)
This study utilizes information from Walkup et al. (2008). That study utilized the C.A.T. Project to examine the therapeutic relationship with cognitive-behavioral therapists and with pharmacotherapists for youth from the Child/Adolescent Anxiety Multimodal Study. Youth were randomly assigned to receive the C.A.T. Project, sertraline, their combination, or medication management with pill placebo. Measures utilized include the Child's Perception of Therapeutic Relationship (CPTR), the Anxiety Disorders Interview Schedule for DSM–IV–Child and Parent Versions (ADIS-IV-C/P), the Clinical Global Impressions Scales (CGI), and the Pediatric Anxiety Rating Scale (PARS). Results indicate that for youth who received the C.A.T. Project only, a stronger therapeutic relationship predicted positive treatment outcome. In contrast, the therapeutic relationship did not predict outcome for youth receiving sertraline, combined treatment, or placebo. Limitations include reliance on self-reported measures and lack of follow-up.

Length of controlled postintervention follow-up: None.

Ginsburg, G. S., Becker, E. M., Keeton, C. P., Sakolsky, D., Piacentini, J., Albano, A. M., Compton, S. N., Iyengar, S., Sullivan, K., Caporino, N., Peris, T., Birmaher, B., Rynn, M., March J., & Kendall, P. C. (2014). Naturalistic follow-up of youths treated for pediatric anxiety disorders. Journal of the American Medical Association Psychiatry (JAMA Psychiatry), 71(3), 310-318. https://doi.org/10.1001/jamapsychiatry.2013.4186

Type of Study: Randomized controlled trial
Number of Participants: 288

Population:

• Age — 11-26 years (Mean=17 years)
• Race/Ethnicity — 81.6% White, 8.7% African American, 8% Hispanic, 3.1% Asian, and 6.6% Other
• Gender — 160 Females
• Status — Participants were children with a primary diagnosis of separation or generalized anxiety disorder or social phobia.

Location/Institution: Not specified

Summary: (To include basic study design, measures, results, and notable limitations)
This study utilizes information from Walkup et al. (2008). It was an evaluation of Coping Cat [now called C.A.T. Project for youth aged 12-18] to determine whether clinical improvement and treatment type (e.g., cognitive behavioral therapy, medication, or their combination) in the original 2008 study predicted remission of anxiety and improvement in global functioning at follow-up an average of 6 years after randomization and to examine predictors of outcomes at follow-up. Youths were randomized to 1 of 4 interventions (Coping Cat, medication, combination, or pill placebo) in the Child/Adolescent Anxiety Multimodal Study. Measures utilized include the Clinical Global Impression–Severity scale, the Children's Global Assessment Scale, the Brief Family Assessment Measure, the Brief Symptom Inventory, the State-Trait Anxiety Inventory–Trait, the Anxiety Disorders Interview Schedule Supplemental Services Form, and the Life Events Scale. Results indicate that almost half of the sample (46.5%) was in remission at the 6-year follow-up. Responders to the initial treatment in the 2008 study were significantly more likely to be in remission at the 6-year follow-up and had less severe anxiety symptoms and higher functioning. There were no differences in outcomes at the 6-year follow-up across the 4 interventions. Limitations include the attrition rate of the original study sample at the follow-up time point, the naturalistic nature of the follow-up study (as other treatments may have occurred), and the generalizability of the findings (particularly to male youths and youths from nonwhite and lower-socioeconomic status [SES] backgrounds).

Length of controlled postintervention follow-up: Mean=6 years, Range=4-9 years.

Compton, S. N., Peris, T. S., Almirall, D., Birmaher, B., Sherrill, J., Kendall, P. C., March, J. S., Gosch, E. A., Ginsburg, G. S., Rynn, M. A., Piacentini, J. C., McCracken, J. T., Keeton, C. P., Suveg, C. M., Aschenbrand, S. G., Sakolsky, D., Iyengar, S., Walkup, J. T., & Albano, A. M. (2014). Predictors and moderators of treatment response in childhood anxiety disorders: Results from the CAMS trial. Journal of Consulting and Clinical Psychology, 82(2), 212-224. https://doi.org/10.1037/a0035458

Type of Study: Randomized controlled trial
Number of Participants: 488

Population:

• Age — 7-17 years
• Race/Ethnicity — 81.6% White, 8.7% African American, 8% Hispanic, 3.1% Asian, and 6.6% Other
• Gender — 49.6% Females
• Status — Participants were children with a primary diagnosis of separation or generalized anxiety disorder or social phobia.

Location/Institution: Not specified

Summary: (To include basic study design, measures, results, and notable limitations)
This study utilizes information from Walkup et al. (2008). That study utilized the Coping Cat [now called C.A.T. Project for youth aged 12-18] treatment manual to examine predictors and moderators of treatment outcomes among youths meeting criteria for diagnoses of separation anxiety disorder, social phobia, or generalized anxiety disorder who were randomly assigned to receive either Coping Cat, sertraline (SRT), their combination (COMB), or medication management with pill placebo (PBO) in the Child/Adolescent Anxiety Multimodal Study (CAMS). Measures utilized include the Multidimensional Anxiety Scale for Children (MASC), Screen for Child Anxiety-Related Emotional Disorders (SCARED), Mood and Feelings Questionnaire (MFQ), Child Anxiety Impact Scale (CAIS), the Physical Symptom Checklist (PSC), Anxiety Disorder Interview Schedule–Clinician Severity Rating (ADIS–CSR), Clinical Global Impression Scale–Severity (CGI–S), Children's Global Assessment Scale (CGAS), State–Trait Anxiety Inventory, A-Trait Scale (STAI–A–Trait), Brief Symptom Inventory (BSI), Brief Family Assessment Measure–III (BFAM–III), and the Caregiver Strain Questionnaire (CSQ). Results indicate that in youth with lower levels of baseline symptom severity and less caregiver strain had better outcomes independent of the type of treatment received. Having more severe and impairing anxiety, greater caregiver strain, and a principal diagnosis of social phobia were associated with less favorable outcomes. Limitations include the exclusion of some potential moderators (e.g., comorbid depression) as part of the study design and lack of follow-up.

Length of controlled postintervention follow-up: None.

Gonzalez, A., Peris, T. S., Vreeland, A., Kiff, C. J., Kendall, P. C., Compton, S. N., Albano, A. M., Birmaher, B., Ginsburg, G. S., Keeton, C. P., March, J., McCracken, J., Rynn, M., Sherrill, J., Walkup, J. T., & Piacentini, J. (2015). Parental anxiety as a predictor of medication and CBT response for anxious youth. Child Psychiatry & Human Development, 46(1), 84-93. https://doi.org/10.1007/s10578-014-0454-6

Type of Study: Randomized controlled trial
Number of Participants: 488

Population:

• Age — 7-17 years
• Race/Ethnicity — 81.6% White, 8.7% African American, 8% Hispanic, 3.1% Asian, and 6.6% Other
• Gender — 49.6% Females
• Status — Participants were children with a primary diagnosis of separation or generalized anxiety disorder or social phobia.

Location/Institution: Not specified

Summary: (To include basic study design, measures, results, and notable limitations)
This study utilizes information from Walkup et al. (2008). It evaluates how parental anxiety predicted change in pediatric anxiety symptoms across four different interventions: Coping Cat [now called C.A.T. Project for youth aged 12-18], medication (sertraline; SRT), their combination (COMB), and pill placebo (PBO). Youths were randomized to twelve weeks of the Coping Cat, SRT, COMB, or PBO. Measures utilized include Anxiety Disorders Interview Schedule for DSM-IVTR, Child Version (ADIS-IV), the Pediatric Anxiety Rating Scale (PARS), the Mood and Feelings Questionnaire, Child- and Parent-reports (MFQ-C/MFQ-P), and the State-Trait Anxiety Inventory-Trait Scale (STAI -Trait). Results indicated that parental anxiety was not associated with youth's pretreatment anxiety symptom severity. Controlling for parental trait anxiety, youth depressive symptoms, and youth age, there was a main effect of COMB treatment indicating that youth who received both medication and the Coping Cat benefitted most. In addition, there was an interaction between parental anxiety and SRT treatment. Counter to expectations, higher levels of parental anxiety predicted a more favorable symptom trajectory within the SRT condition leading to faster and greater reduction in youth anxiety compared to youths whose parents had lower levels of anxiety. Parental anxiety did not significantly influence youth anxiety trajectories in the other treatment conditions. Limitations include generalizability to other ethnic populations and lack of follow-up.

Length of controlled postintervention follow-up: None.

Peris, T. S., Compton, S. N., Kendall, P. C., Birmaher, B., Sherrill, J., March, J., Gosch, E., Ginsburg, G., Rynn, M., McCracken, J. T., Keeton, C. P., Sakolsky, D., Suveg, C., Aschenbrand, S., Almirall, D., Iyengar, S., Walkup, J. T., Albano, A. M., & Piacentini, J. (2015). Trajectories of change in youth anxiety during cognitive-behavior therapy. Journal of Consulting and Clinical Psychology, 83(2), 239-252. https://doi.org/10.1037/a0038402

Type of Study: Randomized controlled trial
Number of Participants: 488 children

Population:

• Age — 7-17 years
• Race/Ethnicity — 78.9% White, 12.1% Hispanic, 9.0% Black, 2.5% Asian, 1.2% American Indian, 0.4% Pacific Islander, and 8.0% other
• Gender — 49.6% Female
• Status — Participants were children with a primary diagnosis of separation or generalized anxiety disorder or social phobia.

Location/Institution: United States

Summary: (To include basic study design, measures, results, and notable limitations)
This study utilizes information Walkup, et al. (2008) to evaluate changes in treatment trajectories following the introduction of three specific CBT components in the Child/Adolescent Anxiety Multimodal Treatment Study (CAMS). Youths were randomized to 1 of 4 interventions (C.A.T. Project, medication, combination, or placebo). Measures utilized include the Clinical Global Impression Scale-Severity (CGI-S), the Children's Global Assessment Scale (CGAS), the Anxiety Disorders Interview Schedule-Child/Parent Versions (ADIS C/P), the Negative Affect Self-Statement Questionnaire (NASSQ), the Physical Symptom Checklist (PSC), and the Pediatric Anxiety Rating Scale (PARS). Results indicate that introduction in the C.A.T. Project 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). Limitations include the attrition rate of the original study sample at the follow-up time point, lack of follow-up, and reliance on self-reported measures.

Length of controlled postintervention follow-up: None.

Kendall, P. C., Cummings, C. M., Villabø, M. A., Narayanan, M. K., Treadwell, K., Birmaher, B., Compton, S., Piacentini, J., Sherrill, J., Walkup, J., Gosch, E., Keeton, C., Ginsburg, G., Suveg, C., & Albano, A. M. (2016). Mediators of change in the Child/Adolescent Anxiety Multimodal Treatment Study. Journal of Consulting and Clinical Psychology, 84(1), 1-14. https://doi.org/10.1037/a0039773

Type of Study: Randomized controlled trial
Number of Participants: 488 children

Population:

• Age — 7-17 years
• Race/Ethnicity — 78.9% White, 12.1% Hispanic, 9.0% Black, 2.5% Asian, 1.2% American Indian, 0.4% Pacific Islander, and 8.0% Other
• Gender — 49.6% Female
• Status — Participants were children with a primary diagnosis of separation or generalized anxiety disorder or social phobia.

Location/Institution: United States

Summary: (To include basic study design, measures, results, and notable limitations)
This study utilizes information from Walkup et al. (2008) to evaluate (a) anxious self-talk and (b) coping efficacy as potential mediators in Child/Adolescent Anxiety Multimodal Treatment Study (CAMS). Youths were randomized to 1 of 4 interventions (C.A.T. Project, medication, combination, or placebo) in the Child/Adolescent Anxiety Multimodal Study. Measures utilized include the Coping Questionnaire, Parent and Child/Youth Versions (CQ-C/P), the Negative Affectivity Self-Statement Questionnaire (NASSQ), the Anxiety Disorders Interview Schedule-Child/Parent Versions (ADIS-IV-C/P), and the Pediatric Anxiety Rating Scale (PARS). Results indicate that residualized gains in coping efficacy mediated gains in the C.A.T. Project, 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. Limitations include the attrition rate of the original study sample at the follow-up time point, additional services or medication during the follow-up period was not controlled, and the generalizability of the findings (particularly to male youths and youths from nonwhite and lower-SES backgrounds).

Length of controlled postintervention follow-up: 3 months.

Peterman, J. S., Carper, M. M., Elkins, R. M., Comer, J. S., Pincus, D. B., & Kendall, P. C. (2016). The effects of cognitive-behavioral therapy for youth anxiety on sleep problems. Journal of Anxiety Disorders, 37, 78-88. https://doi.org/10.1016/j.janxdis.2015.11.006

Type of Study: Pretest-posttest study
Number of Participants: 69

Population:

• Age — 7-17 years (Mean=10.86 years)
• Race/Ethnicity — 84.1% Caucasian, 2.9% Asian, 1.0% Hispanic, 1.0% African American, and 5.7% Other
• Gender — 44.9% Males
• Status — Participants were youth with a primary diagnosis generalized anxiety disorder or social phobia.

Location/Institution: Temple University Child and Adolescent Anxiety Disorders Clinic (CAADC) or the Boston University Center for Anxiety and Related Disorders (CARD)

Summary: (To include basic study design, measures, results, and notable limitations)
This study examined (a) whether sleep-related problems (SRPs) improved following cognitive-behavioral therapy (CBT) for youth with anxiety disorders, (b) whether variables that may link anxiety and SRPs (e.g., presleep arousal, family accommodation, sleep hygiene) changed during treatment, and(c) whether such changes predicted SRPs at posttreatment. Youth received the empirically supported treatment (cognitive-behavioral) for their respective principal diagnoses (Coping Cat [now called C.A.T. Project for youth aged 12-18], MATCH, CBT for Selective Mutism, Riding the Wave, or CBT for obsessive compulsive disorder). Measures utilized include the Children's Sleep Habit Questionnaire (CSHQ), the Family Accommodation Checklist and Interference Scale(FACLIS), the Children's Sleep Hygiene Scale (CSHS), the Sleep Self Report (SSR), the Pre-Sleep Arousal Survey for Children (PSAS-C), the Adolescent Sleep Hygiene Scale (ASHS), the Anxiety Disorder Interview Schedule for Children and Parents (ADIS-IV-C/P), and the Clinical Global Impression-Improvement Scale (CGI-I). Results indicated that parent-reported SRPs improved from pretreatment to posttreatment and that treatment responders with regard to anxiety yielded greater SRP improvements than nonresponders. Parent report of bedtime resistance and sleep anxiety showed significant improvements. Youth reported lower rates of SRPs compared to their parents and did not demonstrate pretreatment to posttreatment changes in SRPs. Pre-sleep arousal and family accommodation decreased overtreatment but did not predict lower SRPs at posttreatment. Higher accommodation was correlated with greater SRPs. Sleep hygiene evidenced no change and did not mediate links between accommodation and posttreatment SRPs. Limitations include study lacked objective sleep measures, lack of randomization, and lack of comparison group.

Length of controlled postintervention follow-up: None.