Anxiety DisordersNCT03171363
Gaze Contingent Feedback for Anxiety Disorders in Children
A study testing Gaze-contingent feedback in people with Anxiety Disorders, run by Tel Aviv University at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of anxiety disorders in children. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Gaze-contingent feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2017to 1 Apr 2018
- 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Primary diagnosis of GAD, SOP, or SAD.
- Co-morbid attention deficit hyperactivity disorder (ADHD) or depressive disorders must be treated with medication and stable.
- Tics or impulse control problems must be treated with medication, stable and cause minimal or no impairment.
Who cannot join
- meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation.
- show high likelihood of hurting themselves or others.
- have not been living with a primary caregiver who is legally able to give consent for the child's participation.
- be a victim of previously undisclosed abuse requiring investigation or ongoing supervision.
- be involved currently in another psycho-social treatment.
- have a serious vision problem that is not corrected with prescription lenses.
- have a physical disability that interferes with their ability to click a mouse button rapidly and repeatedly.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gaze-Contingent Music Reward Treatment for Anxiety Disorders in Children: A Case Series
The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of anxiety disorders in children.
Read the detailed description
Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. The purpose of this study is to determine whether giving gaze-contingent feedback is an effective treatment for anxiety disorders in clinically anxious 6-10 year-olds children. Participants will be assessed using clinical interviews and parent- and self-rated questionnaires before and after eight training sessions. Outcome measures will be anxiety symptoms and depression as measured by gold standard questionnaires as well as structured clinical interviews with children and their parents. Attentional threat bias and Attentional control will also be measured to explore potential mediators of ABMT's effect on anxiety.
- Conditions
- Anxiety Disorders
- Being tested
- Gaze-contingent feedback
- Keywords
- Attention bias modification treatment, Anxiety disorders, Attention training
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaze-contingent feedbackBehavioural
Participants will receive gaze-contingent feedback according to their viewing patterns
| Study group | Role | What they receive |
|---|---|---|
| Gaze-contingent feedback | Experimental | Participants will receive gaze-contingent feedback according to their viewing patterns Receives: Behavioral: Gaze-contingent feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in anxiety symptoms - the Pediatric Anxiety Rating (PARS)
The PARS assesses global anxiety severity across different anxiety disorders in children
Measured: Post treatment (1 week after treatment completion)
Secondary outcomes (1)
Change from baseline in anxiety related emotional disorders symptoms - Child/Parent (the SCARED 41-item)
The SCARED is a 41-item self and parent-report instrument designed to assess anxiety in children.
Measured: Post treatment (1 week after treatment completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Apr 2017
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yair Bar-Haim, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171363
- Sponsor's protocol ID
- TAUANX
- Status last verified
- Sep 2018
- First submitted
- 28 May 2017
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaze-Contingent Music Reward Treatment for Anxiety Disorders in Children: A Case Series
- ClinicalTrials.gov ID
- NCT03171363
- Acronym / sponsor ID
- TAUANX
- Conditions
- Anxiety Disorders
- Keywords
- Attention bias modification treatment, Anxiety disorders, Attention training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 31 May 2017 (actual)
- 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.
The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of anxiety disorders in children.
Detailed description
Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. The purpose of this study is to determine whether giving gaze-contingent feedback is an effective treatment for anxiety disorders in clinically anxious 6-10 year-olds children. Participants will be assessed using clinical interviews and parent- and self-rated questionnaires before and after eight training sessions. Outcome measures will be anxiety symptoms and depression as measured by gold standard questionnaires as well as structured clinical interviews with children and their parents. Attentional threat bias and Attentional control will also be measured to explore potential mediators of ABMT's effect on anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gaze-contingent feedback | Experimental | Behavioral: Gaze-contingent feedbackParticipants will receive gaze-contingent feedback according to their viewing patterns |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Primary diagnosis of GAD, SOP, or SAD.
- Co-morbid attention deficit hyperactivity disorder (ADHD) or depressive disorders must be treated with medication and stable.
- Tics or impulse control problems must be treated with medication, stable and cause minimal or no impairment.
Key exclusion criteria (7 listed)
- meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation.
- show high likelihood of hurting themselves or others.
- have not been living with a primary caregiver who is legally able to give consent for the child's participation.
- be a victim of previously undisclosed abuse requiring investigation or ongoing supervision.
- be involved currently in another psycho-social 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 |
|---|---|---|
| Gaze-contingent feedbackParticipants will receive gaze-contingent feedback according to their viewing patterns | Behavioural | Gaze-contingent feedback |
Primary outcome
Change from baseline in anxiety symptoms - the Pediatric Anxiety Rating (PARS)
Time frame: Post treatment (1 week after treatment completion)
The PARS assesses global anxiety severity across different anxiety disorders in children
1 secondary outcome
Change from baseline in anxiety related emotional disorders symptoms - Child/Parent (the SCARED 41-item)
Time frame: Post treatment (1 week after treatment completion)
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 18 Sep 2018.
- Individual participant dataSharing planned: No
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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 Gaze-contingent feedback in people with Anxiety Disorders, run by Tel Aviv University at 1 site in Israel.
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 3 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 18 Sep 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 Israel. 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. 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?
Change from baseline in anxiety symptoms - the Pediatric Anxiety Rating (PARS) (time frame: Post treatment (1 week after treatment completion)). 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 18 Sep 2018.