Using Smartphones to Enhance the Treatment of Childhood Anxiety

Boys and girls between the ages of 9-14 who have anxiety and a parent or caregiver are being
asked to participate in this study. Interested participants who contact the study will be
asked to undergo a brief phone pre-screen to determine initial eligibility.

After completing a phone pre-screen, potential participants for the Phase 2 trial will be
invited to the lab to complete a clinical intake interview. Clinical information will be
obtained from parent and child by a trained research staff member. The research staff member
will have specific training to a high degree of reliability in conducting the diagnostic
interviews relevant to this research study.

Participants that meet study criteria based on the clinical information obtained at the first
study visit will be invited to begin a course of Cognitive Behavior Therapy (CBT), an
empirically validated talk therapy commonly used to treat children with anxiety. Children
will receive individual treatment using the Brief Coping Cat Manual. The Coping Cat program
(Kendall 1994) is an empirically supported child-focused CBT treatment for children with
anxiety disorders. Throughout the program, children are encouraged to practice techniques
learned during therapy sessions through homework or "Show-That-I-Can" (STIC) tasks. Parents
attend weekly check-ins and two parent-only sessions. STIC tasks will consist of specific
SmartCAT modules in the smartphone app as assigned at the end of each session. Participants
might be asked to interact with other children and adolescents or study staff as well as
leave the therapy building. This is to allow participants to become more comfortable in
situations that make them feel anxious by gradually exposing them to the specific situation.
Parents are not treated as co-clients, but are considered consultants to the child's
treatment and are asked to provide some collaboration and assistance in exposure planning and
homework.

Treatment will be delivered by Masters-level therapists who will have completed training in
CBT. They will attend a weekly supervision session with Dr. Silk, with consultation from Dr.
Kendall on difficult cases via videoconference. All sessions will be videotaped.

SMARTPHONE PROTOCOL:

Prior to the first therapy session, the child and a parent will be trained how to use the
SmartCAT app. Youth will be provided with an Android smartphone for the duration of the
study. If the child already has an Android phone, the app will be installed on the
participant's phone in order to decrease participant burden of carrying an additional phone.

Participants will be given a study-provided, pre-programmed smartphone on which they will
enter their responses to a series of questions about moods and daily experiences using an app
developed for this study. The child will receive an electronic notification message once per
day and will be prompted through a series of questions about what he/she is doing, who he/she
is with, how he/she is feeling, worries or stressful events, and how he/she coped with these
events. It should take the child approximately 5 minutes each time to complete the questions.
The child will only be prompted to answer these questions outside of school hours and on
weekends. Participant data will be securely sent to study therapists via a clinician portal
connected to the app to be reviewed weekly. The therapists may then integrate this
information into treatment and provide customized feedback to the patient.

Parents will be asked to complete an online diary to keep track of what skills their child
uses during the week. After completion of the initial screening visit, parents are asked to
complete the Skills Use Diary daily for seven days. After this seven day period, they will be
asked to complete a diary entry twice per week throughout 8 weeks of treatment, totaling 30
entries. At the end of treatment, subjects will again be asked to complete the diary daily
for another seven days. Participants will receive links to the online diary and instructions
for completion via email (see references and other attachments for the email script). Diaries
should take no longer than 10 min per day to complete. The data will be encrypted and stored
securely through the online survey system Qualtrics.

POST-TREATMENT and 2-MONTH FOLLOW-UP:

All clinical, skill acquisition, and skill utilization measures (including the parent 7 day
diary) will be repeated at post-treatment (approximately 10 weeks) and 2 month follow-up We
will use Qualtrics, a secure internet data collection system, for administering diaries and
questionnaires.

Inclusion Criteria:

- Participants will be 40 children of either sex ages 9 years, 0 months to 14 years, 11
months with DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety
Disorder (SAD), and/or Social Phobia (SP) as identified by the Kiddie Schedule of
Affective Disorders.

The primary caregiver is defined as the person who has the most responsibility for taking
care of the child. While this is typically the mother, it can be the father, an adoptive
parent or other legal guardian. The primary caregiver must be a legal guardian of the
child.

Exclusion Criteria:

1. Requires current ongoing treatment with psychoactive medications other than
stimulants.

2. Acutely suicidal or at risk for harm to self or others.

3. Neuromuscular or neurological disorder.

4. Reading level below 80 on the Wide Range Achievement Test-4 (WRAT-4)

5. Medical illnesses or medications taken for an illness as determined by study
physicians that would affect study adherence, and subject's emotional state.

6. Current comorbid diagnosis of: primary major depressive disorder (MDD) (subjects who
have primary GAD with co-morbid MDD that is secondary in terms of course and
functional impact are not excluded), obsessive-compulsive disorder (OCD),
post-traumatic stress disorder (PTSD), conduct disorder, substance abuse or
dependence, and ADHD combined type or predominantly hyperactive-impulsive type.

7. Lifetime diagnosis of autism spectrum disorder, bipolar disorder, psychotic
depression, schizophrenia, or schizoaffective disorder.