Trial Outcomes & Findings for Attention Bias Modification Training in Youth With Subthreshold Impairing Anxiety (NCT NCT02410967)
NCT ID: NCT02410967
Last Updated: 2018-06-19
Results Overview
posttreatment clinician rating of youth anxiety symptom severity over the past 7 days. The name of the measure is the Pediatric Anxiety Rating Scale (PARS). The PARS is a clinician rated measure of the severity of youths' anxiety symptoms. Total scores on the PARS range from 0 to 35, with higher scores representing more severe anxiety.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
7 days
Results posted on
2018-06-19
Participant Flow
Trial Period: Treatment Phase (4 Weeks) Total Started: 53 \[Protocol Enrollment: 53\] Trial Period:Follow-up Phase (8 Weeks) Total Started: 48
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
|
27
|
26
|
|
Treatment Phase (4 Weeks)
COMPLETED
|
26
|
22
|
|
Treatment Phase (4 Weeks)
NOT COMPLETED
|
1
|
4
|
|
Follow-up Phase (8 Weeks)
STARTED
|
26
|
22
|
|
Follow-up Phase (8 Weeks)
COMPLETED
|
22
|
16
|
|
Follow-up Phase (8 Weeks)
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Attention Bias Modification Training in Youth With Subthreshold Impairing Anxiety
Baseline characteristics by cohort
| Measure |
Attention Bias Modification
n=27 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=26 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=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
9.67 years
STANDARD_DEVIATION 2.68 • n=99 Participants
|
8.85 years
STANDARD_DEVIATION 2.53 • n=107 Participants
|
9.27 years
STANDARD_DEVIATION 2.61 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Intent to treat
posttreatment clinician rating of youth anxiety symptom severity over the past 7 days. The name of the measure is the Pediatric Anxiety Rating Scale (PARS). The PARS is a clinician rated measure of the severity of youths' anxiety symptoms. Total scores on the PARS range from 0 to 35, with higher scores representing more severe anxiety.
Outcome measures
| Measure |
Placebo Attention Task
n=26 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.
|
Attention Bias Modification
n=27 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.
|
|---|---|---|
|
Pediatric Anxiety Rating Scale at Posttreatment
|
7.73 units on a scale
Standard Deviation 4.81
|
7.21 units on a scale
Standard Deviation 5.66
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Intent to Treat
follow-up clinician rating of youth anxiety symptom severity over the past 7 days. The name of the measure is the Pediatric Anxiety Rating Scale (PARS). The PARS is a clinician rated measure of the severity of youths' anxiety symptoms. Total scores on the PARS range from 0 to 35, with higher scores representing more severe anxiety.
Outcome measures
| Measure |
Placebo Attention Task
n=26 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.
|
Attention Bias Modification
n=27 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.
|
|---|---|---|
|
Pediatric Anxiety Rating Scale at Follow-up
|
5.69 units on a scale
Standard Deviation 4.42
|
8.42 units on a scale
Standard Deviation 6.21
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Intent to Treat
posttreatment parent rating of youth anxiety symptom severity over the past 14 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety.
Outcome measures
| Measure |
Placebo Attention Task
n=26 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.
|
Attention Bias Modification
n=27 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.
|
|---|---|---|
|
Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment
|
20.16 units on a scale
Standard Deviation 11.75
|
19.82 units on a scale
Standard Deviation 14.54
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Intent to Treat
follow-up parent rating of youth anxiety symptom severity over the past 14 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety.
Outcome measures
| Measure |
Placebo Attention Task
n=26 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.
|
Attention Bias Modification
n=27 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.
|
|---|---|---|
|
Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow-up
|
17.13 units on a scale
Standard Deviation 10.86
|
21.96 units on a scale
Standard Deviation 16.82
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Intent to Treat
posttreatment youth self-rating of youth anxiety symptom severity over the past 14 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child self-rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.
Outcome measures
| Measure |
Placebo Attention Task
n=26 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.
|
Attention Bias Modification
n=27 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.
|
|---|---|---|
|
Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment
|
14.72 units on a scale
Standard Deviation 10.61
|
17.88 units on a scale
Standard Deviation 13.76
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Intent to Treat
follow-up youth self-rating of youth anxiety symptom severity over the past 14 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child self-rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.
Outcome measures
| Measure |
Placebo Attention Task
n=26 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.
|
Attention Bias Modification
n=27 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.
|
|---|---|---|
|
Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-up
|
11.88 units on a scale
Standard Deviation 10.88
|
20.41 units on a scale
Standard Deviation 15.66
|
Adverse Events
Attention Bias Modification
Serious events: 0 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
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place