This competing continuation of the six site Child/Adolescent Anxiety Multimodal Treatment Study (CAMS, U01MH64092), which is currently in year 3 of the 4 year award, is being submitted in response to PA-01-123 inviting collaborative research on Clinical Studies of Mental Disorders. Anxiety disorders are among the most common conditions affecting youth with point prevalence of 12-20%. The three most common childhood onset anxiety disorders, separation anxiety disorder (SAD), generalized anxiety disorder (GAD) and social phobia (SP), routinely co-occur and cause clinically significant impairment in academic, social, and family functioning. Left untreated, they foretell persistent anxiety, major depression and substance abuse into adulthood. Hence, effective treatments for childhood-onset anxiety disorders promise to alleviate and perhaps to prevent morbidity and even mortality. In randomized controlled trials, members of our group have shown that cognitive-behavioral therapy (CBT) and the selective serotonin reuptake inhibitors (SSRIs) are effective for anxiety disorders in youth. To date there are no controlled trails comparing CBT and an SSRI, alone and in combination, to a suitable control condition in the same patient population. CAMS is a two phase, masked, randomized controlled trial for youth ages 7-17 years with SAD, SP and GAD. Phase I is a 12-week, acute efficacy study; subjects are randomized (2:2:2:1) to CBT, sertraline, their combination or pill placebo. Phase II involves a 6-month maintenance phase for Phase I responders. We employ manualized intervention and assessment protocols, including the assessment of adverse events, and state-of-the-art quality assurance procedures that insure uniform cross-site administration of the study protocol. All subjects are evaluated at all assessment points for both beneficial and adverse outcomes. Assessments include parent, child and clinician ratings; to preserve study blindness, the primary outcomes are assessed by blind independent evaluators. The proposed competing continuation, which builds on demonstrated feasibility in sample recruitment and retention, will extend CAMS for 24 months and expand the CAMS sample from 318 to 478 subjects to increase power (1) to precisely estimate effect size differences on the primary dependent measures and (2) to promote the identification of subgroup differences (moderator analyses) and mechanisms of treatment response (mediator analyses). ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01MH064089-06
Application #
7240488
Study Section
Special Emphasis Panel (ZMH1-ERB-P (07))
Program Officer
Hsiao, John
Project Start
2001-07-01
Project End
2010-05-31
Budget Start
2007-06-11
Budget End
2010-05-31
Support Year
6
Fiscal Year
2007
Total Cost
$442,092
Indirect Cost
Name
Johns Hopkins University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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Hale, Amy E; Ginsburg, Golda S; Chan, Grace et al. (2018) Mediators of Treatment Outcomes for Anxious Children and Adolescents: The Role of Somatic Symptoms. J Clin Child Adolesc Psychol 47:94-104
Swan, Anna J; Kendall, Philip C; Olino, Thomas et al. (2018) Results from the Child/Adolescent Anxiety Multimodal Longitudinal Study (CAMELS): Functional outcomes. J Consult Clin Psychol 86:738-750
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Becker-Haimes, Emily M; Jensen-Doss, Amanda; Birmaher, Boris et al. (2018) Parent-youth informant disagreement: Implications for youth anxiety treatment. Clin Child Psychol Psychiatry 23:42-56
Caporino, Nicole E; Sakolsky, Dara; Brodman, Douglas M et al. (2017) Establishing Clinical Cutoffs for Response and Remission on the Screen for Child Anxiety Related Emotional Disorders (SCARED). J Am Acad Child Adolesc Psychiatry 56:696-702
Lee, Phyllis; Zehgeer, Asima; Ginsburg, Golda S et al. (2017) Child and Adolescent Adherence With Cognitive Behavioral Therapy for Anxiety: Predictors and Associations With Outcomes. J Clin Child Adolesc Psychol :1-12
Gonzalez, Araceli; Rozenman, Michelle; Langley, Audra K et al. (2017) Social Interpretation Bias in Children and Adolescents with Anxiety Disorders: Psychometric Examination of the Self-report of Ambiguous Social Situations for Youth (SASSY) Scale. Child Youth Care Forum 46:395-412

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