Emotion DysregulationMONRADO2NCT02851810
Oculomotor Markers and Attachment in Adolescents
A study testing oculomotor parameter recording, attachment scale interview (ASI) and psychophysiological recording in people with Emotion Dysregulation, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The study aims to identify specific visual scanning patterns of attachment pictures in adolescent with different attachment style. Read more about this study
- Who is it for?
- Ages 13 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Dysregulation
- What is being tested?
- oculomotor parameter recording, attachment scale interview (ASI) and psychophysiological recording
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2013to 8 Jun 2017
- 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 13 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- non hospitalized child who is going to school
Who cannot join
- not french-speaker vision problem more than 20 cigarettes/day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oculomotor and Neurophysiological Markers of Emotion Regulation and Attachment Styles in Adolescence
The study aims to identify specific visual scanning patterns of attachment pictures in adolescent with different attachment style.
Read the detailed description
Oculomotor parameters will be assessed during visualization of 2 sets of pictures. The first set presents a distress picture and is followed by a slide composed of 3 pictures (one representing comfort, one representing complicity and the last representing a neutral scene).
Psychophysiological parameters (skin conductance reactivity-SCR) is also assess during this visualization.
- Conditions
- Emotion Dysregulation
- Being tested
- oculomotor parameter recording, attachment scale interview (ASI), psychophysiological recording, psychometric assessment, parent interview
- Keywords
- attachment, oculomotor marker, emotion regulation
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oculomotor parameter recordingBehavioural
visual scanning behavior is assessed during visualization of emotional pictures
attachment scale interview (ASI)Behavioural
ASI is used to determine the attachment style of each participant
psychophysiological recordingBehavioural
this consists of the measurement of the skin conductance reactivity (SCR) during the picture visualization
psychometric assessmentBehavioural
self administered questionnaires are used to assess anxiety, depression and alexithymia.
parent interviewBehavioural
an interview of the adolescent parent is performed in order to assess the confusion of the parent-child role and the interaction between the child and its parent.
What is being measured
The primary outcome is the main question the study is designed to answer.
number of entry in distress pictures
these parameters will be compared between the different types of attachment.
Measured: within 1 year after inclusion
saccade duration in distress picture
time spent looking at the distress picture these parameters will be compared between the different types of attachment.
Measured: within 1 year after inclusion
average of the number of entry in comfort picture vs neutral and complicity pictures
these parameters will be compared between the different types of attachment.
Measured: within 1 year after inclusion
average of the saccade duration in comfort picture vs neutral and complicity pictures
these parameters will be compared between the different types of attachment.
Measured: within 1 year after inclusion
Secondary outcomes (3)
Amplitude of SCR
this parameter will be compared between the different types of attachment.
Measured: within 1 year after inclusion
interaction with the parent: score to the GPACS (goal-corrected partnership in adolescence coding system)
the quality of the interaction with the parent and the confusion of the parent-child role will be compared between the different attachment types.
Measured: within 1 year after inclusion
Reaction time in SCR
this parameter will be compared between the different types of attachment.
Measured: within 1 year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study start19 Dec 2013
- Primary completion8 Jun 2017
- Study completion8 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotion DysregulationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauriane Vulliez-Coady, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851810
- Sponsor's protocol ID
- API/2012/35
- Acronym
- MONRADO2
- Status last verified
- Oct 2018
- First submitted
- 26 Jul 2016
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Szymanska M, Monnin J, Tio G, Vidal C, Girard F, Galdon L, Smith CC, Bifulco A, Nezelof S, Vulliez-Coady L. How do adolescents regulate distress according to attachment style? A combined eye-tracking and neurophysiological approach. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Mar 8;89:39-47. doi: 10.1016/j.pnpbp.2018.08.019. Epub 2018 Aug 27.
PubMed 30165119
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oculomotor and Neurophysiological Markers of Emotion Regulation and Attachment Styles in Adolescence
- ClinicalTrials.gov ID
- NCT02851810
- Acronym / sponsor ID
- MONRADO2 / API/2012/35
- Conditions
- Emotion Dysregulation
- Keywords
- attachment, oculomotor marker, emotion regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 19 Dec 2013 (actual)
- Primary completion
- 8 Jun 2017 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 2 Aug 2016 (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.
The study aims to identify specific visual scanning patterns of attachment pictures in adolescent with different attachment style.
Detailed description
Oculomotor parameters will be assessed during visualization of 2 sets of pictures. The first set presents a distress picture and is followed by a slide composed of 3 pictures (one representing comfort, one representing complicity and the last representing a neutral scene).
Psychophysiological parameters (skin conductance reactivity-SCR) is also assess during this visualization.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- non hospitalized child who is going to school
Key exclusion criteria (1 listed)
- not french-speaker vision problem more than 20 cigarettes/day
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 |
|---|---|---|
| oculomotor parameter recordingvisual scanning behavior is assessed during visualization of emotional pictures | Behavioural | – |
| attachment scale interview (ASI)ASI is used to determine the attachment style of each participant | Behavioural | – |
| psychophysiological recordingthis consists of the measurement of the skin conductance reactivity (SCR) during the picture visualization | Behavioural | – |
| psychometric assessmentself administered questionnaires are used to assess anxiety, depression and alexithymia. | Behavioural | – |
| parent interviewan interview of the adolescent parent is performed in order to assess the confusion of the parent-child role and the interaction between the child and its parent. | Behavioural | – |
Primary outcome
number of entry in distress pictures
Time frame: within 1 year after inclusion
these parameters will be compared between the different types of attachment.
saccade duration in distress picture
Time frame: within 1 year after inclusion
time spent looking at the distress picture these parameters will be compared between the different types of attachment.
average of the number of entry in comfort picture vs neutral and complicity pictures
Time frame: within 1 year after inclusion
these parameters will be compared between the different types of attachment.
average of the saccade duration in comfort picture vs neutral and complicity pictures
Time frame: within 1 year after inclusion
these parameters will be compared between the different types of attachment.
3 secondary outcomes
Amplitude of SCR
Time frame: within 1 year after inclusion
interaction with the parent: score to the GPACS (goal-corrected partnership in adolescence coding system)
Time frame: within 1 year after inclusion
Reaction time in SCR
Time frame: within 1 year after inclusion
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 2 Oct 2018.
- Derived from this study: PubMed 30165119Szymanska M, Monnin J, Tio G, Vidal C, Girard F, Galdon L, Smith CC, Bifulco A, Nezelof S, Vulliez-Coady L. How do adolescents regulate distress according to attachment style? A combined eye-tracking and neurophysiological approach. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Mar 8;89:39-47. doi: 10.1016/j.pnpbp.2018.08.019. Epub 2018 Aug 27.
- Individual participant dataSharing planned: Undecided
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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.
Lauriane Vulliez-Coady, MD PhD principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oculomotor parameter recording, attachment scale interview (ASI) and psychophysiological recording in people with Emotion Dysregulation, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 1 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 2 Oct 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 France. 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?
number of entry in distress pictures (time frame: within 1 year after inclusion). The study lists 4 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 NCT02851810, which also lists 1 linked publication.
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 2 Oct 2018.