Sequencing CBT for Child Anxiety: CBT Plus Sertraline Versus Switch to Sertraline

This project proposes to conduct a pilot study to collect preliminary data on a
'personalized adaptive treatment' approach for children and adolescents with anxiety
disorders. All youth patients in this two site study will first receive CBT and all then
will be re-assessed at mid-treatment (8 sessions). Patients who show a partial response or
no response following 8 sessions of CBT will be randomized to either a switch to SRT alone
or CBT augmentation with SRT.

Inclusion Criteria:

- meet criteria for a primary Diagnostic and Statistical Manual of Mental Disorders,
5th Edition (DSM-5) anxiety disorder of generalized anxiety disorder (GAD), social
phobia (SOP), and separation anxiety disorder (SAD) using the DSM-5 version of the
Anxiety Disorders Interview Schedule -Child and Parent Versions (ADIS-C/P)

- receive a mean score of 4 or greater on the ADIS-C/P Clinician Rating Scale of
Severity (CSR)

- cease all other psychosocial treatment upon consultation with the clinic staff and
the service provider

- not currently using any psychotropic medication other than a stable dose of stimulant
medication treatment for comorbid ADHD. Youth who are on a stable dose of stimulant
medication (i.e., a minimum of six months at the same dose) will be included so as
not to limit generalizability.

- be between 8 and 16 years old

- have a negative pregnancy test, if they are menstruating girls. If participating in
Phase II of the project (i.e., sertraline [SRT] vs. CBT + SRT) and they are sexually
active, they must be using an appropriate method of birth control. Of additional note
is that it is an allowable possibility to include children who have coexisting
psychiatric diagnoses of lesser severity than the three target disorders including
attention deficit-hyperactivity disorder (ADHD) while receiving stable doses of
stimulant, obsessive compulsive, post-traumatic stress, oppositional defiant, and
conduct disorders.

Exclusion Criteria:

- meet for primary diagnosis of any DSM-5 disorder other than GAD, SOP, and SAD

- have any of the following disorders (e.g., primary, secondary, tertiary) - Pervasive
Developmental Disorders, Mental Retardation, Selective Mutism, Organic Mental
Disorders, Bipolar Disorder, Tourette's Disorder, Schizophrenia and Other Psychotic
Disorders. Drug or alcohol abuse/dependence will also be exclusionary.

- report the presence of any active suicidal ideation or a past suicide attempt in the
last 6 months. Adolescents with a history of non-lethal self-harm behaviors (e.g.,
cutting) will be allowed to enroll if they meet other criteria

- have an intellectual disability as reported by guardian. If IQ is questionable or has
not been assessed, the Block Design and Vocabulary subtests of the Wechsler
Intelligence Scale for Children (WISC-IV) will be administered. If the youth receives
an IQ subtest score < 6 on either one of these two subtests of the WISC-IV, a full
scale IQ score (FSIQ) will be obtained. Children with FSIQ < 80 will be excluded

- be a victim of past or present undisclosed abuse requiring investigation or ongoing
supervision by the Connecticut Department of Children and Families.

- have an unstable medical condition or a medical condition that could be worsened by
selective serotonin reuptake inhibitors (SSRIs) such as a bleeding disorder or an
active seizure disorder

- be using concomitant non-psychiatric medications that could be unsafe for use with
sertraline (anticoagulants, triptans for migraine treatment, dextromethorphan)

- have a history of nonresponse to two adequate trials of SSRIs or an adequate trial of
CBT or have a history of intolerance or nonresponse to sertraline

- be girls who are pregnant or are sexually active and are not using an effective
method of birth control.