Trial Outcomes & Findings for Attention Bias Modification Training for Child Anxiety CBT Nonresponders (NCT NCT01819311)
NCT ID: NCT01819311
Last Updated: 2017-10-18
Results Overview
The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)
Results posted on
2017-10-18
Participant Flow
Participant milestones
| Measure |
Attention Bias Modification
Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders.
|
Placebo Attention Task
The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability.
|
|---|---|---|
|
Treatment Phase (4 Weeks)
STARTED
|
33
|
31
|
|
Treatment Phase (4 Weeks)
COMPLETED
|
31
|
30
|
|
Treatment Phase (4 Weeks)
NOT COMPLETED
|
2
|
1
|
|
Follow-up Phase (8 Weeks)
STARTED
|
31
|
30
|
|
Follow-up Phase (8 Weeks)
COMPLETED
|
24
|
23
|
|
Follow-up Phase (8 Weeks)
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Attention Bias Modification Training for Child Anxiety CBT Nonresponders
Baseline characteristics by cohort
| Measure |
Attention Bias Modification
n=33 Participants
Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders.
|
Placebo Attention Task
n=31 Participants
The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.18 years
STANDARD_DEVIATION 2.69 • n=5 Participants
|
11.26 years
STANDARD_DEVIATION 2.16 • n=7 Participants
|
11.8 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Pediatric Anxiety Rating Scale
|
14.55 units on a scale
STANDARD_DEVIATION 3.63 • n=5 Participants
|
13.12 units on a scale
STANDARD_DEVIATION 3.90 • n=7 Participants
|
13.96 units on a scale
STANDARD_DEVIATION 3.84 • n=5 Participants
|
|
Screen for Child Anxiety and Related Emotional Disorders - Parent Version
|
27.74 units on a scale
STANDARD_DEVIATION 14.57 • n=5 Participants
|
26.24 units on a scale
STANDARD_DEVIATION 12.46 • n=7 Participants
|
26.76 units on a scale
STANDARD_DEVIATION 13.68 • n=5 Participants
|
|
Screen for Child Anxiety and Related Emotional Disorders - Child Version
|
23.03 units on a scale
STANDARD_DEVIATION 12.81 • n=5 Participants
|
22.87 units on a scale
STANDARD_DEVIATION 15.65 • n=7 Participants
|
22.99 units on a scale
STANDARD_DEVIATION 14.92 • n=5 Participants
|
PRIMARY outcome
Timeframe: post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.
Outcome measures
| Measure |
Attention Bias Modification
n=31 Participants
Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders.
|
Placebo Attention Task
n=30 Participants
The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability.
|
|---|---|---|
|
Clinician Rating on the Pediatric Anxiety Rating Scale
|
8.88 units on a scale
Standard Deviation 5.64
|
8.12 units on a scale
Standard Deviation 5.03
|
PRIMARY outcome
Timeframe: 8-week follow-upThe Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.
Outcome measures
| Measure |
Attention Bias Modification
n=24 Participants
Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders.
|
Placebo Attention Task
n=23 Participants
The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability.
|
|---|---|---|
|
Clinician Rating on the Pediatric Anxiety Rating Scale
|
9.50 units on a scale
Standard Deviation 6.05
|
5.95 units on a scale
Standard Deviation 4.39
|
SECONDARY outcome
Timeframe: post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)The Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P) assesses anxiety symptom severity in youth ages 6-17 years. The parent rates youth anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.
Outcome measures
| Measure |
Attention Bias Modification
n=31 Participants
Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders.
|
Placebo Attention Task
n=30 Participants
The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability.
|
|---|---|---|
|
Screen for Child Anxiety Related Emotional Disorders - Parent Version
|
22.22 units on a scale
Standard Deviation 14.23
|
18.05 units on a scale
Standard Deviation 12.49
|
SECONDARY outcome
Timeframe: post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)The Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C) assesses anxiety symptom severity in youth ages 6-17 years. The child rates his or her anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.
Outcome measures
| Measure |
Attention Bias Modification
n=31 Participants
Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders.
|
Placebo Attention Task
n=30 Participants
The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability.
|
|---|---|---|
|
Screen for Child Anxiety Related Emotional Disorders - Child Version
|
14.15 units on a scale
Standard Deviation 12.78
|
12.83 units on a scale
Standard Deviation 13.60
|
SECONDARY outcome
Timeframe: 8-week follow-upThe Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P) assesses anxiety symptom severity in youth ages 6-17 years. The parent rates youth anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.
Outcome measures
| Measure |
Attention Bias Modification
n=24 Participants
Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders.
|
Placebo Attention Task
n=23 Participants
The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability.
|
|---|---|---|
|
Screen for Child Anxiety Related Emotional Disorders - Parent Version
|
21.05 units on a scale
Standard Deviation 14.12
|
17.98 units on a scale
Standard Deviation 13.16
|
SECONDARY outcome
Timeframe: 8-week follow-upThe Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C) assesses anxiety symptom severity in youth ages 6-17 years. The child rates his or her anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.
Outcome measures
| Measure |
Attention Bias Modification
n=24 Participants
Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders.
|
Placebo Attention Task
n=23 Participants
The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability.
|
|---|---|---|
|
Screen for Child Anxiety Related Emotional Disorders - Child Version
|
17.75 units on a scale
Standard Deviation 16.45
|
12.09 units on a scale
Standard Deviation 12.18
|
Adverse Events
Attention Bias Modification
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Attention Task
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Attention Bias Modification
n=33 participants at risk
Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders.
|
Placebo Attention Task
n=31 participants at risk
The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability.
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
3.0%
1/33 • Number of events 1 • Duration of study participation (12 weeks on average)
|
0.00%
0/31 • Duration of study participation (12 weeks on average)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place