Using Smartphones to Enhance the Treatment of Childhood Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The primary goal of this research study is to develop an interactive smartphone app that
      could be used to increase the effectiveness of talk therapy such as cognitive behavioral
      therapy (CBT) for child anxiety.
    

Detailed description: 
      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.
    

Intervention name(s): Ecological Momentary Treatment Enhancement
Intervention type(s): Other
Intervention description(s): Participants will be given a 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. Participant data will be sent to study therapists to be reviewed weekly. The therapist will integrate this information into treatment and provide customized feedback to the patient.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: child anxiety; worries; fears; talk therapy