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Attention Bias Modification Training for Child Anxiety CBT Nonresponders

Attention Bias Modification Training for Child Anxiety CBT Nonresponders

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01819311
Enrollment
64
Registered
2013-03-27
Start date
2013-04-01
Completion date
2017-06-23
Last updated
2017-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders

Brief summary

This project will test Attention Bias Modification Training (ABMT) among children and adolescents who have completed a full protocol of cognitive behavior therapy (CBT) for anxiety and still meet criteria for a primary diagnosis of an anxiety disorder. The purpose of this project is to determine whether ABMT leads to reductions in anxiety and related impairment, relative to a placebo task condition.

Detailed description

This application proposes a pilot test of Attention Bias Modification Training (ABMT) among children and adolescents who have completed a full protocol of cognitive behavior therapy (CBT) for anxiety and still meet criteria for a primary diagnosis of an anxiety disorder a full year after completion of CBT. There is currently not a single empirical study in the youth anxiety treatment literature that has systematically examined a treatment augment for youth who fail to respond to a full course of CBT. Empirical efforts to address this issue are important because youths who do not respond to CBT continue to suffer emotional distress and impairment associated with anxiety disorders, experience frustration and demoralization by perceived failure, and likely pose a financial burden on the health care system. ABMT is a novel translational treatment for anxiety based on experimental and neuroscience research findings on attention processes. Research demonstrates that ABMT leads to reductions in anxiety and its disorders. Based on recent theory and research demonstrating an attention bias toward threat predicts CBT nonresponse among anxious youth, researchers have postulated that ABMT may hold promise as an augment to CBT because of its specific focus on attention bias that targets both frontal-cortical and subcortical circuitry. This study will recruit an estimated 70 children and adolescents who have completed a 12-14 week CBT trial for anxiety disorders and at the one year follow-up continue to meet criteria for a primary diagnosis of an anxiety disorders. These 70 children and adolescents (ages 8-16 years) will be randomly assigned to complete eight biweekly sessions of either ABMT or a placebo control (PC) task. Clinician ratings on youth anxiety severity will be collected and evaluated as the primary outcome. Youth self ratings on anxiety symptoms and parent ratings on youth anxiety symptoms will be collected and evaluated as secondary outcomes. All measures will be collected before condition assignment (pretreatment), at immediate posttreatment, and at an eight week follow up. The following specific aims will be addressed. Aim 1: Test whether ABMT leads to significantly lower levels of anxiety at posttreatment as compared to a Placebo Control Task. Aim 2: Examine whether ABMT leads to significantly lower levels of anxiety as compared to a Placebo Control Task at a follow up evaluation eight weeks posttreatment. This would suggest the maintenance of ABMT effects after eight weeks of no treatment. Aim 3: Gain perspective on the viability of variables as potential mediators and moderator of ABMT so as to inform decisions about whether to pursue these variables in a future R01. The variables proposed as potential mediators are attention bias toward threat and threat-related interpretation bias. The variable proposed as a potential moderator is attention control. Overall, this project will provide critically needed data on ABMT as a treatment augment for youth with anxiety disorders who do not respond CBT. With these data in hand, the field will be in a better position to determine whether and how ABMT may be used optimally among anxious youth who are likely to need more than CBT.

Interventions

BEHAVIORALAttention 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.

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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Florida International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

* 8-16 years old * completed a 12-14 week cognitive behavioral therapy for anxiety * a primary DSM-IV diagnosis of generalized anxiety disorder, social anxiety disorder, or separation anxiety disorder * if other psychiatric disorders are present, they must be treated with medication and stable

Exclusion criteria

* meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation * a high likelihood of harming self or others * not been living with a primary caregiver for at least 6 months who is legally able to give consent for the child's participation * previously undisclosed abuse requiring investigation or ongoing supervision by the Department of Social Services; * involved currently in another psychosocial/behavioral treatment * a serious vision problem that is not corrected with prescription lenses * a physical disability that interferes with the ability to click a mouse button rapidly and repeatedly

Design outcomes

Primary

MeasureTime frameDescription
Clinician Rating on the Pediatric Anxiety Rating Scalepost-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.

Secondary

MeasureTime frameDescription
Screen for Child Anxiety Related Emotional Disorders - Parent Versionpost-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.
Screen for Child Anxiety Related Emotional Disorders - Child Versionpost-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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
33
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.
31
Total64

Baseline characteristics

CharacteristicAttention Bias ModificationPlacebo Attention TaskTotal
Age, Continuous12.18 years
STANDARD_DEVIATION 2.69
11.26 years
STANDARD_DEVIATION 2.16
11.8 years
STANDARD_DEVIATION 2.6
Ethnicity (NIH/OMB)
Hispanic or Latino
28 Participants27 Participants55 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants4 Participants9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Pediatric Anxiety Rating Scale14.55 units on a scale
STANDARD_DEVIATION 3.63
13.12 units on a scale
STANDARD_DEVIATION 3.9
13.96 units on a scale
STANDARD_DEVIATION 3.84
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
2 Participants3 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants2 Participants
Race (NIH/OMB)
White
28 Participants27 Participants55 Participants
Screen for Child Anxiety and Related Emotional Disorders - Child Version23.03 units on a scale
STANDARD_DEVIATION 12.81
22.87 units on a scale
STANDARD_DEVIATION 15.65
22.99 units on a scale
STANDARD_DEVIATION 14.92
Screen for Child Anxiety and Related Emotional Disorders - Parent Version27.74 units on a scale
STANDARD_DEVIATION 14.57
26.24 units on a scale
STANDARD_DEVIATION 12.46
26.76 units on a scale
STANDARD_DEVIATION 13.68
Sex: Female, Male
Female
18 Participants12 Participants30 Participants
Sex: Female, Male
Male
15 Participants19 Participants34 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 330 / 31
other
Total, other adverse events
0 / 330 / 31
serious
Total, serious adverse events
1 / 330 / 31

Outcome results

Primary

Clinician Rating on the Pediatric Anxiety Rating Scale

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.

Time frame: 8-week follow-up

ArmMeasureValue (MEAN)Dispersion
Attention Bias ModificationClinician Rating on the Pediatric Anxiety Rating Scale9.50 units on a scaleStandard Deviation 6.05
Placebo Attention TaskClinician Rating on the Pediatric Anxiety Rating Scale5.95 units on a scaleStandard Deviation 4.39
Primary

Clinician Rating on the Pediatric Anxiety Rating Scale

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.

Time frame: post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)

ArmMeasureValue (MEAN)Dispersion
Attention Bias ModificationClinician Rating on the Pediatric Anxiety Rating Scale8.88 units on a scaleStandard Deviation 5.64
Placebo Attention TaskClinician Rating on the Pediatric Anxiety Rating Scale8.12 units on a scaleStandard Deviation 5.03
Secondary

Screen for Child Anxiety Related Emotional Disorders - Child Version

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.

Time frame: post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)

ArmMeasureValue (MEAN)Dispersion
Attention Bias ModificationScreen for Child Anxiety Related Emotional Disorders - Child Version14.15 units on a scaleStandard Deviation 12.78
Placebo Attention TaskScreen for Child Anxiety Related Emotional Disorders - Child Version12.83 units on a scaleStandard Deviation 13.6
Secondary

Screen for Child Anxiety Related Emotional Disorders - Child Version

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.

Time frame: 8-week follow-up

ArmMeasureValue (MEAN)Dispersion
Attention Bias ModificationScreen for Child Anxiety Related Emotional Disorders - Child Version17.75 units on a scaleStandard Deviation 16.45
Placebo Attention TaskScreen for Child Anxiety Related Emotional Disorders - Child Version12.09 units on a scaleStandard Deviation 12.18
Secondary

Screen for Child Anxiety Related Emotional Disorders - Parent Version

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.

Time frame: post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)

ArmMeasureValue (MEAN)Dispersion
Attention Bias ModificationScreen for Child Anxiety Related Emotional Disorders - Parent Version22.22 units on a scaleStandard Deviation 14.23
Placebo Attention TaskScreen for Child Anxiety Related Emotional Disorders - Parent Version18.05 units on a scaleStandard Deviation 12.49
Secondary

Screen for Child Anxiety Related Emotional Disorders - Parent Version

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.

Time frame: 8-week follow-up

ArmMeasureValue (MEAN)Dispersion
Attention Bias ModificationScreen for Child Anxiety Related Emotional Disorders - Parent Version21.05 units on a scaleStandard Deviation 14.12
Placebo Attention TaskScreen for Child Anxiety Related Emotional Disorders - Parent Version17.98 units on a scaleStandard Deviation 13.16

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026