AnxietyBRAINSNCT02401282
Attention and Social Behavior in Children
A study testing Attention Bias Modification and Dot-probe task in people with Anxiety, run by Penn State University at 1 site in United States.
Trial summary
This study examines the way attention may be linked to temperamental risk for anxiety, social behavior and brain processes. The study aims to see if temperamentally at risk youth display an attention bias towards threat, and if anxiety symptoms can be reduced through attentional bias modification training. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Attention Bias Modification and Dot-probe task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 251 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to 17 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 9-12 year olds who do not meet exclusionary criteria (split into groups based on high and low temperamental shyness)
Who cannot join
- presence or permanent metal orthodontics or implanted metal devices
- severe psychiatric diagnosis
- IQ under 70 as assessed by the WISC
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University Child Study Center
University Park, Pennsylvania, 16801
About this study
This study examines the way attention may be linked to temperamental risk for anxiety, social behavior and brain processes. The study aims to see if temperamentally at risk youth display an attention bias towards threat, and if anxiety symptoms can be reduced through attentional bias modification training.
- Conditions
- Anxiety
- Being tested
- Attention Bias Modification, Dot-probe 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
This is a modification of the dot-probe task (placebo task) designed to train attention away from threat
Dot-probe taskBehavioural
This is the active control placebo condition that simply measures levels of attention to threat
| Study group | Role | What they receive |
|---|---|---|
| ABM | Experimental | Attention bias modification Receives: Behavioral: Attention Bias Modification |
| Placebo | Placebo comparator | Dot-probe task Receives: Behavioral: Dot-probe task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Symptoms
parent and child report of child's anxiety symptoms
Measured: 8 weeks
Attention bias levels
performance on computerized attention task
Measured: 8 weeks
Electrophysiological and neural correlates of attention bias
EEG and fMRI measures
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startDec 2011
- Primary completion17 Dec 2016
- Study completion17 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Koraly E. Perez-Edgar, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401282
- Sponsor's protocol ID
- 5R01MH094633-04
- Other IDs
- 5R01MH094633-04
- Acronym
- BRAINS
- Status last verified
- Jan 2018
- First submitted
- 24 Mar 2015
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
LoBue V, Perez-Edgar K. Sensitivity to social and non-social threats in temperamentally shy children at-risk for anxiety. Dev Sci. 2014 Mar;17(2):239-47. doi: 10.1111/desc.12110. Epub 2013 Nov 28.
PubMed 24283271McDermott JM, Perez-Edgar K, Henderson HA, Chronis-Tuscano A, Pine DS, Fox NA. A history of childhood behavioral inhibition and enhanced response monitoring in adolescence are linked to clinical anxiety. Biol Psychiatry. 2009 Mar 1;65(5):445-8. doi: 10.1016/j.biopsych.2008.10.043. Epub 2008 Dec 24.
PubMed 19108817Perez-Edgar K, McDermott JN, Korelitz K, Degnan KA, Curby TW, Pine DS, Fox NA. Patterns of sustained attention in infancy shape the developmental trajectory of social behavior from toddlerhood through adolescence. Dev Psychol. 2010 Nov;46(6):1723-30. doi: 10.1037/a0021064.
PubMed 20873921Perez-Edgar K, Reeb-Sutherland BC, McDermott JM, White LK, Henderson HA, Degnan KA, Hane AA, Pine DS, Fox NA. Attention biases to threat link behavioral inhibition to social withdrawal over time in very young children. J Abnorm Child Psychol. 2011 Aug;39(6):885-95. doi: 10.1007/s10802-011-9495-5.
PubMed 21318555Perez-Edgar K, Roberson-Nay R, Hardin MG, Poeth K, Guyer AE, Nelson EE, McClure EB, Henderson HA, Fox NA, Pine DS, Ernst M. Attention alters neural responses to evocative faces in behaviorally inhibited adolescents. Neuroimage. 2007 May 1;35(4):1538-46. doi: 10.1016/j.neuroimage.2007.02.006. Epub 2007 Feb 15.
PubMed 17376704Williams LR, Degnan KA, Perez-Edgar KE, Henderson HA, Rubin KH, Pine DS, Steinberg L, Fox NA. Impact of behavioral inhibition and parenting style on internalizing and externalizing problems from early childhood through adolescence. J Abnorm Child Psychol. 2009 Nov;37(8):1063-75. doi: 10.1007/s10802-009-9331-3.
PubMed 19521761Liu P, Taber-Thomas BC, Fu X, Perez-Edgar KE. Biobehavioral Markers of Attention Bias Modification in Temperamental Risk for Anxiety: A Randomized Control Trial. J Am Acad Child Adolesc Psychiatry. 2018 Feb;57(2):103-110. doi: 10.1016/j.jaac.2017.11.016. Epub 2017 Nov 28.
PubMed 29413142
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention and Social Behavior in Children
- ClinicalTrials.gov ID
- NCT02401282
- Acronym / sponsor ID
- BRAINS / 5R01MH094633-04
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2011
- Primary completion
- 17 Dec 2016 (actual)
- Study completion
- 17 Dec 2016 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the way attention may be linked to temperamental risk for anxiety, social behavior and brain processes. The study aims to see if temperamentally at risk youth display an attention bias towards threat, and if anxiety symptoms can be reduced through attentional bias modification training.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABM | Experimental | Behavioral: Attention Bias ModificationAttention bias modification |
| Placebo | Placebo comparator | Behavioral: Dot-probe taskDot-probe task |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 9-12 year olds who do not meet exclusionary criteria (split into groups based on high and low temperamental shyness)
Key exclusion criteria (3 listed)
- presence or permanent metal orthodontics or implanted metal devices
- severe psychiatric diagnosis
- IQ under 70 as assessed by the WISC
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 ModificationThis is a modification of the dot-probe task (placebo task) designed to train attention away from threat | Behavioural | ABM |
| Dot-probe taskThis is the active control placebo condition that simply measures levels of attention to threat | Behavioural | Placebo |
Primary outcome
Anxiety Symptoms
Time frame: 8 weeks
parent and child report of child's anxiety symptoms
Attention bias levels
Time frame: 8 weeks
performance on computerized attention task
Electrophysiological and neural correlates of attention bias
Time frame: 8 weeks
EEG and fMRI measures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Background: PubMed 24283271LoBue V, Perez-Edgar K. Sensitivity to social and non-social threats in temperamentally shy children at-risk for anxiety. Dev Sci. 2014 Mar;17(2):239-47. doi: 10.1111/desc.12110. Epub 2013 Nov 28.
- Background: PubMed 19108817McDermott JM, Perez-Edgar K, Henderson HA, Chronis-Tuscano A, Pine DS, Fox NA. A history of childhood behavioral inhibition and enhanced response monitoring in adolescence are linked to clinical anxiety. Biol Psychiatry. 2009 Mar 1;65(5):445-8. doi: 10.1016/j.biopsych.2008.10.043. Epub 2008 Dec 24.
- Background: PubMed 20873921Perez-Edgar K, McDermott JN, Korelitz K, Degnan KA, Curby TW, Pine DS, Fox NA. Patterns of sustained attention in infancy shape the developmental trajectory of social behavior from toddlerhood through adolescence. Dev Psychol. 2010 Nov;46(6):1723-30. doi: 10.1037/a0021064.
- Background: PubMed 21318555Perez-Edgar K, Reeb-Sutherland BC, McDermott JM, White LK, Henderson HA, Degnan KA, Hane AA, Pine DS, Fox NA. Attention biases to threat link behavioral inhibition to social withdrawal over time in very young children. J Abnorm Child Psychol. 2011 Aug;39(6):885-95. doi: 10.1007/s10802-011-9495-5.
- Background: PubMed 17376704Perez-Edgar K, Roberson-Nay R, Hardin MG, Poeth K, Guyer AE, Nelson EE, McClure EB, Henderson HA, Fox NA, Pine DS, Ernst M. Attention alters neural responses to evocative faces in behaviorally inhibited adolescents. Neuroimage. 2007 May 1;35(4):1538-46. doi: 10.1016/j.neuroimage.2007.02.006. Epub 2007 Feb 15.
- Background: PubMed 19521761Williams LR, Degnan KA, Perez-Edgar KE, Henderson HA, Rubin KH, Pine DS, Steinberg L, Fox NA. Impact of behavioral inhibition and parenting style on internalizing and externalizing problems from early childhood through adolescence. J Abnorm Child Psychol. 2009 Nov;37(8):1063-75. doi: 10.1007/s10802-009-9331-3.
- Derived from this study: PubMed 29413142Liu P, Taber-Thomas BC, Fu X, Perez-Edgar KE. Biobehavioral Markers of Attention Bias Modification in Temperamental Risk for Anxiety: A Randomized Control Trial. J Am Acad Child Adolesc Psychiatry. 2018 Feb;57(2):103-110. doi: 10.1016/j.jaac.2017.11.016. Epub 2017 Nov 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Dot-probe task in people with Anxiety, run by Penn State 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 1 inclusion and 3 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 16 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anxiety Symptoms (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02401282, which also lists 7 linked publications.
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 16 Jan 2018; AzTrials last refreshed its copy on 29 Oct 2026.