Emotion DysregulationMONRADO1NCT02851836
Attachment Image Data Set Validation in Adolescent
A study testing image visualization and quotation in people with Emotion Dysregulation, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
this study aims to validate a picture data set that particularly activates the attachment process and that could be used in attachment studies. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Dysregulation
- What is being tested?
- image visualization and quotation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 133 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Nov 2013
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- adolescent going to high school not hospitalized
Who cannot join
- mental retardation non comprehension of french visual deficit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of an Attachment Picture Set in School-adolescent
this study aims to validate a picture data set that particularly activates the attachment process and that could be used in attachment studies.
Read the detailed description
Pictures have been chosen to represent several emotions: distress, comfort, complicity and neutral.
- Conditions
- Emotion Dysregulation
- Being tested
- image visualization and quotation
- Keywords
- attachment, adolescent, picture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
image visualization and quotationBehavioural
two sets of 60 pictures are shown to the adolescents. we ask them to quote for their valence, hedonicity, arousal and to characterize the emotion elicited in each picture.
This evaluation takes approximately 1hour.
What is being measured
The primary outcome is the main question the study is designed to answer.
mean score of valence in the SAM (self assessment manikin system)
the hedonicity is assessed for each picture. The characterization of the set is performed using the mean score of hedonicity for each type of picture (distress, comfort, complicity and neural)
Measured: at inclusion
Secondary outcomes (3)
mean score of arousal in the SAM (self assessment manikin system)
the hedonicity is assessed for each picture. The characterization of the set is performed using the mean score of arousal for each type of picture (distress, comfort, complicity and neural)
Measured: at inclusion
mean score of dominance in the SAM (self assessment manikin system)
the hedonicity is assessed for each picture. The characterization of the set is performed using the mean score of dominance for each type of picture (distress, comfort, complicity and neural)
Measured: at inclusion
emotional categorization of the picture
continuous scales for different emotions (distress, comfort, joy-complicity hate, horror) are presented. Subjects have to quote them for each picture.
Measured: at 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 startOct 2012
- Primary completionMay 2013
- Study completionNov 2013
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 133 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
- NCT02851836
- Sponsor's protocol ID
- P/2012/152
- Acronym
- MONRADO1
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2016
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Szymanska M, Monnin J, Noiret N, Tio G, Galdon L, Laurent E, Nezelof S, Vulliez-Coady L. The Besancon Affective Picture Set-Adolescents (the BAPS-Ado): Development and validation. Psychiatry Res. 2015 Aug 30;228(3):576-84. doi: 10.1016/j.psychres.2015.04.055. Epub 2015 Jun 20.
PubMed 26163722
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Attachment Picture Set in School-adolescent
- ClinicalTrials.gov ID
- NCT02851836
- Acronym / sponsor ID
- MONRADO1 / P/2012/152
- Conditions
- Emotion Dysregulation
- Keywords
- attachment, adolescent, picture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Nov 2013 (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.
this study aims to validate a picture data set that particularly activates the attachment process and that could be used in attachment studies.
Detailed description
Pictures have been chosen to represent several emotions: distress, comfort, complicity and neutral.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- adolescent going to high school not hospitalized
Key exclusion criteria (1 listed)
- mental retardation non comprehension of french visual deficit
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 |
|---|---|---|
| image visualization and quotationtwo sets of 60 pictures are shown to the adolescents. we ask them to quote for their valence, hedonicity, arousal and to characterize the emotion elicited in each picture. This evaluation takes approximately 1hour. | Behavioural | – |
Primary outcome
mean score of valence in the SAM (self assessment manikin system)
Time frame: at inclusion
the hedonicity is assessed for each picture. The characterization of the set is performed using the mean score of hedonicity for each type of picture (distress, comfort, complicity and neural)
3 secondary outcomes
mean score of arousal in the SAM (self assessment manikin system)
Time frame: at inclusion
mean score of dominance in the SAM (self assessment manikin system)
Time frame: at inclusion
emotional categorization of the picture
Time frame: at 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 Aug 2016.
- Results publication: PubMed 26163722Szymanska M, Monnin J, Noiret N, Tio G, Galdon L, Laurent E, Nezelof S, Vulliez-Coady L. The Besancon Affective Picture Set-Adolescents (the BAPS-Ado): Development and validation. Psychiatry Res. 2015 Aug 30;228(3):576-84. doi: 10.1016/j.psychres.2015.04.055. Epub 2015 Jun 20.
- 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.
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 image visualization and quotation 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 Aug 2016. 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?
mean score of valence in the SAM (self assessment manikin system) (time frame: at inclusion). 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 NCT02851836, 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 Aug 2016.