Novel Anxiety Treatment
Condition: Cognitive Training; Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The first aim of this study, as mentioned in the attached NIH grant, is to test the
      feasibility and acceptability of a novel computer-based cognitive training program that is
      designed to rehabilitate the brain's ventral attention network (VAN), a brain system
      associated with anxiety disorders.

      Once feasibility and acceptability is determined the investigators will begin aim 2 where the
      investigators will test the efficacy of this novel treatment, which could reduce the symptoms
      of anxiety disorders in children (and adults) by training them to actively ignore stimuli in
      turn reducing the activity of the VAN. To test this potential treatment the investigators
      will recruit 60 children with anxiety disorders and 10 healthy children to compare an active
      version of a computer training program to a sham version of training. The investigators will
      also measure VAN reactivity before and after treatment using functional magnetic resonance
      imaging (fMRI). The rationale of this research is that it could lead to a novel, safe,
      mechanism-based treatment for a major public health problem.
    

Detailed description: 
      Children will be recruited through local schools, pediatricians' offices, and through Dr.
      Sylvester's child anxiety clinic by asking staff to present Institutional Review Board (IRB)
      approved recruitment materials to potentially interested families. The investigators will
      also recruit with advertisements and placement of approved flyers, paragraphs and materials
      throughout the greater Washington University community as well as throughout the St. Louis
      community.

      The research assistant will make 'screening materials' available to recruitment sites
      including schools and pediatricians' offices. Staff at these recruitment sites will identify
      potential participants and distribute materials accordingly. Staff will only provide
      recruitment materials and will not answer questions regarding the study -- all questions will
      be answered by study staff. Screening materials will include a consent script, the contact
      information sheet, the SCARED, and the MFQ.

      A member of the research team will review screening materials and contact potential
      participants by phone on the basis of meeting inclusion criteria. This member of the research
      team will provide parent participants with information about the study and required elements
      of consent over the telephone (see attached "Initial Phone Screen") prior to obtaining the
      parent's verbal consent to participate in the screening elements of the study (Initial Phone
      Screen as well as SCARED/MFQ).

      If a parent and child meet eligibility criteria for enrollment in the study based on their
      Initial Phone Screen, and parents indicate they wish to continue with the study, the research
      team will arrange an in-person assessment. On the day of the in-person assessment, a research
      assistant will provide ample time for the parents to read/review the consent form and will
      answer any questions the parent may have prior to signing. Research team members will remind
      participants that their participation is completely voluntary and they can choose to withdraw
      at any time.

      After the in-person assessment, the participant may be asked to return for another visit to
      complete functional magnetic resonance imaging. This additional visit will be optional and
      not a requirement of participation in the overall study. The subject can choose not to
      participate in this phase of the study and may withdraw at any time. If the subject is
      interested, the investigators will obtain a separate document of informed consent for the
      imaging phase. As in the original informed consent document, immediately after the in-person
      assessment, a research assistant will provide ample time for the parents to read/review the
      imaging consent form and will answer any questions the parent may have prior to signing.

      The research assistant may also ask the participants at the end of the in-person assessment
      whether the investigators could call them in the future to participate in the imaging phase
      of the study. If the participant agrees, the team will call the participant within the next 3
      months to set up an appointment. In this case, the informed consent for imaging would be
      obtained at the beginning of the imaging visit with all of the above procedures applying.
    

Intervention name(s): Cognitive Training Program
Intervention type(s): Device
Intervention description(s): The cognitive training program has been designed by Dr. Sylvester. It is a simple computer game looking at some shapes and faces on a computer screen and pressing a button when a target shape appears.
This is the first study to use this exact computer training regimen for testing in its ability to reduce symptoms of anxiety in children with anxiety disorders. Each session of the computer game takes approximately 45-60 minutes and subjects complete 8 total sessions over one month. The computer game involves paying attention to parts of the screen while distracting square boxes appear at other locations. A target "X" appears at the location that participants are paying attention to and the subjects press a button when it appears.
Other intervention name(s): novel computer-based cognitive training program; computer-delivered cognitive training program
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: This study is a randomized control trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment