Novel Anxiety Treatment

Anxiety Disorders Clinical Trial

Official title:

A Novel Mechanism-Based Treatment for Pediatric Anxiety Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03790696
• Other study ID #: 201702012
• Status: Completed
• Phase: N/A
• Start date: February 2, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: July 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety Disorders
• Cognitive Training

Intervention

Device:
• Cognitive Training Program
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.

Locations

Country	Name	City	State
United States	Washinton University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in symptoms of anxiety based on Screen for Anxiety and Related Disorders (SCARED)	The primary outcome will be reduction in symptoms of anxiety as measured by the SCARED in study Phase 2. Total SCARED scores at sessions 2, 4, 6, and 8 will be subtracted from the baseline SCARED score, yielding a delta SCARED score for each visit. These data will be analyzed with a mixed random effects repeated-measures model. In this model, time, treatment (active versus sham), and time x treatment interaction are fixed effects; baseline SCARED scores and subject within treatment are random effects; and delta SCARED scores are the dependent variable. Our hypothesis predicts a significant time x treatment interaction, with a greater decrease in anxiety from pre-training to their last measurement relative to the sham group. A total score of = 25 may indicate the presence of an Anxiety Disorder. Scores higher than 30 are more specific. The minimum score is a 0 and maximum score is 82.	Children/Caregivers will complete the SCARED measure at their baseline appointment before beginning treatment, at treatment session 2,4,6,8, as well as at their final appointment after 4 weeks of completing the training.
Primary	Change in symptoms of anxiety based on Pediatric Anxiety Rating Scale (PARS).	Secondary outcomes will include symptoms of anxiety on the PARS and diagnostic status. The investigators will test whether active versus sham training significantly reduces symptoms in children with anxiety disorders. The primary outcome will be reduction in symptoms of anxiety as measured by the PARS. The investigators will perform a 2 x 2 ANOVA with treatment arm (active versus sham) and time (pre-training versus last measurement) as effects of interest.; The PARS is a clinician-administered measure of pediatric anxiety that incorporates both parent and child report.The total score for the PARS is total of the 7 severity items. The total score ranges from 0 to 35.	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.