Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anxiety Disorders
  • Cognitive Training
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Factorial AssignmentIntervention Model Description: This study is a randomized control trial.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Subjects will be randomized to active vs. sham treatment on a 50/50 basis. The participants and the staff performing the pre- and post- treatment psychiatric interviews will remain blinded throughout the study. Study staff administering the treatment will be aware of the active vs. sham status of the participant, in order to deliver and monitor the appropriate cognitive training program.Primary Purpose: Treatment

Participation Requirements

Age
Between 8 years and 12 years
Gender
Both males and females

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 advertise...

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.

Tracking Information

NCT #
NCT03790696
Collaborators
National Institutes of Health (NIH)
Investigators
Not Provided