Clinical trial NCT03790696: Novel Anxiety Treatment
Official title: A Novel Mechanism-Based Treatment for Pediatric Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Training
Anxiety Disorders
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-01-02
Enrollment: 21
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This study is a randomized control trial.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Symptoms of Anxiety Based on Screen for Anxiety and Related Disorders (SCARED) Parent Report at Baseline and Post Assessment
timeFrame: Children/Caregivers will complete the SCARED measure at their baseline appointment before beginning treatment as well as at their final appointment after 4 weeks of completing the training.
Secondary outcomes:
measure: Change in Symptoms of Anxiety Based on Screen for Anxiety and Related Disorders (SCARED) Child Report at Baseline and Post Assessment
timeFrame: Children/Caregivers will complete the SCARED measure at their baseline appointment before beginning treatment as well as at their final appointment after 4 weeks of completing the training.
measure: Change in Symptoms of Anxiety Based on Pediatric Anxiety Rating Scale (PARS) From Baseline to Post Assessment.
timeFrame: The PARS measure will be collected at the baseline appointment before subjects begin the cognitive training as well as after completing 8 cognitive training sessions in four weeks.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washinton University School of Medicine
state: Missouri
Study officials:
References: