AnxietyNCT02410967
Attention Bias Modification Training in Youth With Subthreshold Impairing Anxiety
A study testing Attention Bias Modification in people with Anxiety, run by Florida International University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Attention Bias Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 30 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 8-16 years old
- meet criteria for subthreshold impairing anxiety
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University Center for Children and Families
Miami, Florida, 33199
About this study
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.
Read the 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.'
- Conditions
- Anxiety
- Being tested
- Attention Bias Modification, Placebo Attention Task
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Bias ModificationBehavioural
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 TaskBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Attention Bias Modification | Experimental | Attention Bias Modification is a computer-based attention training program. Receives: Behavioral: Attention Bias Modification |
| Placebo Attention Task | Placebo comparator | 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. Receives: Behavioral: Placebo Attention Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
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.
Measured: 7 days
Secondary outcomes (4)
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.
Measured: 14 days
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.
Measured: 14 days
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.
Measured: 14 days
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startJul 2014
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy Pettit, PhD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410967
- Sponsor's protocol ID
- UH2MH101470
- Status last verified
- May 2018
- First submitted
- 17 Mar 2015
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Bias Modification Training in Youth With Subthreshold Impairing Anxiety
- ClinicalTrials.gov ID
- NCT02410967
- Acronym / sponsor ID
- UH2MH101470
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Posted 19 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.'
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Bias Modification | Experimental | Behavioral: Attention Bias ModificationAttention Bias Modification is a computer-based attention training program. |
| Placebo Attention Task | Placebo comparator | Behavioral: Placebo Attention TaskThe 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. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 8-16 years old
- meet criteria for subthreshold impairing anxiety
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attention Bias ModificationAt 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. | Behavioural | Attention Bias Modification |
| Placebo Attention TaskAt 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. | Behavioural | Placebo Attention Task |
Primary outcome
Pediatric Anxiety Rating Scale at Posttreatment
Time frame: 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
Time frame: 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.
4 secondary outcomes
Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment
Time frame: 14 days
Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow-up
Time frame: 14 days
Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment
Time frame: 14 days
Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-up
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Pettit, PhD principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention Bias Modification in people with Anxiety, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Anxiety Rating Scale at Posttreatment (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.