Novel Anxiety Treatment
Status: | Recruiting |
---|---|
Conditions: | Anxiety, Cognitive Studies, Cognitive Studies |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 8 - 12 |
Updated: | 1/3/2019 |
Start Date: | February 2, 2017 |
End Date: | June 30, 2019 |
Contact: | Jennifer Harper, BS |
Email: | jenniferharper@wustl.edu |
Phone: | 3142862697 |
A Novel Mechanism-Based Treatment for Pediatric Anxiety Disorders
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.
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.
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.
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.
Inclusion Criteria:
- ages of 8-12
- have a current diagnosis of separation anxiety disorder, generalized anxiety disorder,
and/or social phobia.
Exclusion Criteria:
- prior diagnoses of attention deficit hyperactivity disorder (ADHD)
- autism spectrum disorder
- intellectual disability (IQ<70)
- a significant medical problem
- current use of psychotropic medication other than selective serotonin reuptake
inhibitor (SSRI) (children who are currently taking an SSRI and are still experiencing
symptoms of anxiety will not be excluded).
We found this trial at
1
site
660 South Euclid Avenue
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Principal Investigator: Chad Sylvester, MD, PhD
Phone: 314-286-2697
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