Trial Outcomes & Findings for Novel Anxiety Treatment (NCT NCT03790696)
NCT ID: NCT03790696
Last Updated: 2025-04-27
Results Overview
Another outcome will be change in symptoms of anxiety as measured by the SCARED at the baseline and post training assessments. These scores will be subtracted (post training assessment - baseline assessment) to see the change in anxiety symptoms from the beginning of the study to post treatment. A total score of \>25 may indicate the presence of an Anxiety Disorder. Scores higher than 40 are more specific based on the total score for specific items. Scores for the SCARED can range from 0-82.
COMPLETED
NA
21 participants
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.
2025-04-27
Participant Flow
Recruitment for the Novel Anxiety Treatment Study took place from 2/2/2017 until 12/20/2019. Recruitment was primarily done at pediatrician offices and elementary schools in the St. Louis Metropolitan area. Recruitment ended early due to COVID-19.
Several participants met eligibility criteria for the study, but ultimately did not participate due to withdrawing prior to baseline (2), issues with the time commitment required (1), or not responding to research staff/not being scheduled (4). Overall we consented 21 child/parent dyads. 2 dyads were excluded after baseline due to no clinical anxiety present and 1 dyad was excluded due to the COVID pandemic starting. 18 child/parent dyads were assigned a training program.
Participant milestones
| Measure |
Active Cognitive Training
Participants will complete 30-45 minute cognitive training program twice a week for four weeks.
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.
|
Sham Cognitive Training
Participants will complete 30-45 minute cognitive training program twice a week for four weeks.
Cognitive Training Program: The cognitive training program has been designed by Dr. Sylvester. It is a simple computer game looking at a fixation cross 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 and in the sham training, there are no distractor boxes. A target "X" appears at the location that participants are paying attention to and the subjects press a button when it appears.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
|
Overall Study
COMPLETED
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Active Cognitive Training
Participants will complete 30-45 minute cognitive training program twice a week for four weeks.
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.
|
Sham Cognitive Training
Participants will complete 30-45 minute cognitive training program twice a week for four weeks.
Cognitive Training Program: The cognitive training program has been designed by Dr. Sylvester. It is a simple computer game looking at a fixation cross 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 and in the sham training, there are no distractor boxes. A target "X" appears at the location that participants are paying attention to and the subjects press a button when it appears.
|
|---|---|---|
|
Overall Study
Cognitive training task was too difficult for child to complete.
|
0
|
1
|
Baseline Characteristics
Novel Anxiety Treatment
Baseline characteristics by cohort
| Measure |
Active Cognitive Training
n=10 Participants
Participants will complete 30-45 minute cognitive training program twice a week for four weeks.
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.
|
Sham Cognitive Training
n=8 Participants
Participants will complete 30-45 minute cognitive training program twice a week for four weeks.
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, no distractor boxes appear in the sham training. A target "X" appears at the location that participants are paying attention to and the subjects press a button when it appears.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
9.82 years
STANDARD_DEVIATION 1.17 • n=5 Participants
|
11.09 years
STANDARD_DEVIATION 1.75 • n=7 Participants
|
10.36 years
STANDARD_DEVIATION 1.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
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.Population: This population was recruited through pediatrician offices and elementary schools. All children met DSM-5 criteria for GAD, Social Phobia, or Separation Anxiety Disorder.
Another outcome will be change in symptoms of anxiety as measured by the SCARED at the baseline and post training assessments. These scores will be subtracted (post training assessment - baseline assessment) to see the change in anxiety symptoms from the beginning of the study to post treatment. A total score of \>25 may indicate the presence of an Anxiety Disorder. Scores higher than 40 are more specific based on the total score for specific items. Scores for the SCARED can range from 0-82.
Outcome measures
| Measure |
Active Training Participants
n=10 Participants
Participants who completed the active cognition training
|
Sham Training Participants
n=8 Participants
Participants who completed the sham cognitive training
|
|---|---|---|
|
Change in Symptoms of Anxiety Based on Screen for Anxiety and Related Disorders (SCARED) Parent Report at Baseline and Post Assessment
|
-20.4 units on a scale
Interval -30.17 to -10.63
|
-21.12 units on a scale
Interval -24.93 to -17.32
|
SECONDARY outcome
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.Population: This population was recruited through pediatrician offices and elementary schools. All children met DSM-5 criteria for GAD, Social Phobia, or Separation Anxiety Disorder. We looked at improvement in anxiety across all participants (both active and sham training) since our dataset was smaller than anticipated.
Another outcome will be change in symptoms of anxiety as measured by the SCARED at the baseline and post training assessments. These scores will be subtracted (post training assessment - baseline assessment) to see the change in anxiety symptoms from the beginning of the study to post treatment. A total score of \>25 may indicate the presence of an Anxiety Disorder. Scores higher than 40 are more specific based on the total score for specific items. Scores for the SCARED can range from 0-82.
Outcome measures
| Measure |
Active Training Participants
n=10 Participants
Participants who completed the active cognition training
|
Sham Training Participants
n=8 Participants
Participants who completed the sham cognitive training
|
|---|---|---|
|
Change in Symptoms of Anxiety Based on Screen for Anxiety and Related Disorders (SCARED) Child Report at Baseline and Post Assessment
|
-11.3 units on a scale
Interval -20.48 to -2.13
|
-9.75 units on a scale
Interval -17.32 to -2.18
|
SECONDARY outcome
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.Population: We included all participants with pre and post PARS scores; due to incomplete/missing data, 7 participant scores were calculated for the cognitive training group, and 5 participant scores were calculated for the sham training group.
Secondary outcomes will include the change in symptoms of anxiety on the PARS and diagnostic status. The investigators will test whether active versus sham training significantly changes symptoms in children with anxiety disorders. This will be calculated by subtracting (PARS post treatment - PARS before treatment) The PARS is a clinician-administered measure of pediatric anxiety that incorporates both parent and child report and then a final score is provided by the interviewer. The total score for the PARS is total of the 7 severity items. The total score ranges from 0 to 35. Higher numbers represent more anxiety symptoms therefore worse outcomes.
Outcome measures
| Measure |
Active Training Participants
n=7 Participants
Participants who completed the active cognition training
|
Sham Training Participants
n=5 Participants
Participants who completed the sham cognitive training
|
|---|---|---|
|
Change in Symptoms of Anxiety Based on Pediatric Anxiety Rating Scale (PARS) From Baseline to Post Assessment.
|
-3.86 units on a scale
Interval -8.76 to 1.05
|
-1.4 units on a scale
Interval -5.29 to 2.49
|
Adverse Events
Active Cognitive Training
Sham Cognitive Training
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jennifer Harper / Clinical Research Coordinator
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place