Anxiety
Conditions
Brief summary
This study is a pilot test of Attention Bias Modification Training (ABMT) among clinic referred children and adolescents with subthreshold impairing anxiety (i.e., anxiety and related impairment that fails to meet criteria for an anxiety disorder diagnosis). Half of participants will receive 8 sessions of computer administered ABMT and the other half of participants will receive a 8 sessions of a computer administered control task.
Detailed description
This study will collect preliminary data on Attention Bias Modification Training (ABMT) among clinic referred children and adolescents who display subthreshold impairing anxiety (SubImpAnx; anxiety & related impairment that fails to meet diagnostic criteria for an anxiety disorder). Traditional approaches to mental health service delivery cannot meet current demand. The inadequacies of traditional service delivery are magnified when viewed through the lens of impaired but undiagnosed youth. It is an unaddressed empirical question whether a least restrictive treatment can effectively reduce SubImpAnx in youth. Empirical efforts to address this issue are important because youths with SubImpAnx experience substantial impairment, are at high risk of escalation to full syndrome anxiety disorder, and pose a burden on the health care system. This study will enroll 66 clinic referred children and adolescents (ages 8-16 years) who meet criteria for SubImpAnx. Participants will be randomly assigned to complete 8 sessions of either ABMT or a placebo control (PC) task over 4 weeks. Clinician ratings on youth anxiety severity and impairment will be evaluated as the primary outcome. Youth self ratings and parent ratings on youth anxiety symptoms and impairment will be evaluated as secondary outcomes. All measures will be collected before condition assignment (pretreatment), at immediate posttreatment, and at an 8 week follow up. In addition, initial data will be collected to shed light on whether it would be useful to pursue (a) attention bias to threat as a mediator of ABMT's anxiety reduction effects and (b) dose-response issues related to ABMT's anxiety reduction effects in a subsequent, larger study. The specific aims are: Collect pilot data on the effects of ABMT and a PC task on levels of anxiety and impairment at a post evaluation (Aim 1) and at a follow up (FU) evaluation 8 weeks after the post evaluation (Aim 2); Preliminarily examine whether ABMT leads to lower levels of attention bias toward threatening stimuli as compared to a PC Task at post and 8 week FU (Aim 3); Describe the course of anxiety symptoms and impairment during treatment among youth in the ABMT condition (Aim 4). This project will provide critically needed pilot data on ABMT for youth with SubImpAnx. With these data in hand, the field will be in a better position to determine whether ABMT may be used as a least restrictive intervention among anxious youth who are 'impaired but undiagnosed.'
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.
BEHAVIORALPlacebo 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.
Sponsors
Florida International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* 8-16 years old * meet criteria for subthreshold impairing anxiety
Exclusion criteria
* meet diagnostic criteria for Anxiety Disorder, 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
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Anxiety Rating Scale at Posttreatment | 7 days | 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. |
| Pediatric Anxiety Rating Scale at Follow-up | 7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment | 14 days | 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. |
| Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow-up | 14 days | 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. |
| Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment | 14 days | 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. |
| Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-up | 14 days | 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. |
Countries
United States
Participant flow
Pre-assignment details
Trial Period: Treatment Phase (4 Weeks) Total Started: 53 \[Protocol Enrollment: 53\] Trial Period:Follow-up Phase (8 Weeks) Total Started: 48
Participants by arm
| Arm | Count |
|---|---|
| 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. | 27 |
| 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. | 26 |
| Total | 53 |
Baseline characteristics
| Characteristic | Attention Bias Modification | Placebo Attention Task | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 27 Participants | 26 Participants | 53 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.67 years STANDARD_DEVIATION 2.68 | 8.85 years STANDARD_DEVIATION 2.53 | 9.27 years STANDARD_DEVIATION 2.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 16 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 10 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 26 Participants | 21 Participants | 47 Participants |
| Region of Enrollment United States | 27 Participants | 26 Participants | 53 Participants |
| Sex: Female, Male Female | 10 Participants | 14 Participants | 24 Participants |
| Sex: Female, Male Male | 17 Participants | 12 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 26 |
| other Total, other adverse events | 0 / 27 | 0 / 26 |
| serious Total, serious adverse events | 0 / 27 | 0 / 26 |
Outcome results
Primary
Pediatric Anxiety Rating Scale at Follow-up
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.
Time frame: 7 days
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Bias Modification | Pediatric Anxiety Rating Scale at Follow-up | 8.42 units on a scale | Standard Deviation 6.21 |
| Placebo Attention Task | Pediatric Anxiety Rating Scale at Follow-up | 5.69 units on a scale | Standard Deviation 4.42 |
Primary
Pediatric Anxiety Rating Scale at Posttreatment
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.
Time frame: 7 days
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Bias Modification | Pediatric Anxiety Rating Scale at Posttreatment | 7.21 units on a scale | Standard Deviation 5.66 |
| Placebo Attention Task | Pediatric Anxiety Rating Scale at Posttreatment | 7.73 units on a scale | Standard Deviation 4.81 |
Secondary
Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-up
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.
Time frame: 14 days
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Bias Modification | Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-up | 20.41 units on a scale | Standard Deviation 15.66 |
| Placebo Attention Task | Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-up | 11.88 units on a scale | Standard Deviation 10.88 |
Secondary
Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment
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.
Time frame: 14 days
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Bias Modification | Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment | 17.88 units on a scale | Standard Deviation 13.76 |
| Placebo Attention Task | Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment | 14.72 units on a scale | Standard Deviation 10.61 |
Secondary
Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow-up
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.
Time frame: 14 days
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Bias Modification | Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow-up | 21.96 units on a scale | Standard Deviation 16.82 |
| Placebo Attention Task | Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow-up | 17.13 units on a scale | Standard Deviation 10.86 |
Secondary
Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment
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.
Time frame: 14 days
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Bias Modification | Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment | 19.82 units on a scale | Standard Deviation 14.54 |
| Placebo Attention Task | Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment | 20.16 units on a scale | Standard Deviation 11.75 |