SuicideIPSI2NCT02524535
Alliance With Therapeutic Entourage in Support of Young Suicidal
A study testing Therapeutic alliance in people with Suicide, run by University Hospital, Caen at 1 site in France.
Trial summary
Regardless of age, the quality of hospital care, the confidence that the young can have in the health care team, joining parents are pivotal elements and influence followed. Family support is all the more important as 14% of young people realize a new suicidal act within three months of hospitalization for attempted… Read more about this study
- Who is it for?
- Ages 13 to 40 years
- Conditions the study is for
- Suicide
- What is being tested?
- Therapeutic alliance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2007to Jan 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 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient aged 13-40 years
- From male or female
- Supported the waning of a suicidal gesture.
- speaking and writing fluent French
- living in Upper or Lower Normandy
- signed informed consent form, and at least one of his parents after oral and written information about the study for minors.
Who cannot join
- Age <13 years or > 40 years
- Do not live in the Upper and Lower Normandy regions
- Detained patient
- forced hospitalization
- Patient under guardianship
- Patient with severe somatic pathology (cancer, heart failure, kidney or respiratory, central neurological disorder), scalable, or likely to be life-threatening within a period of less than one year
- Refusal to participate in the study
- Inability to respond
Trial locations and contacts
1 site in 1 country.
About this study
Regardless of age, the quality of hospital care, the confidence that the young can have in the health care team, joining parents are pivotal elements and influence followed. Family support is all the more important as 14% of young people realize a new suicidal act within three months of hospitalization for attempted suicide, and that the essential predictors appear to be the young age and quality of intra-family relationships.
The main objective of this study is to determine, through the construction of an instrument to quantify the therapeutic alliance, defined by the characteristics of the mobilization of the entourage and the mutual commitments in the care of nursing teams and the entourage, the role of early therapeutic alliance with the entourage of suicidal youth 13-40 years, whether primosuicidants or repeat offenders, on short and medium term recurrences and early mortality.
- Conditions
- Suicide
- Being tested
- Therapeutic alliance
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic allianceOther
| Study group | Role | What they receive |
|---|---|---|
| Therapetic alliance | Other | Not described Receives: Other: Therapeutic alliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
characteristics of the mobilization of the entourage evaluated with Family Assessment Device
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startApr 2007
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524535
- Sponsor's protocol ID
- 06-088
- Acronym
- IPSI2
- Status last verified
- Aug 2015
- First submitted
- 13 Aug 2015
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alliance With Therapeutic Entourage in Support of Young Suicidal
- ClinicalTrials.gov ID
- NCT02524535
- Acronym / sponsor ID
- IPSI2 / 06-088
- Conditions
- Suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jan 2013 (actual)
- First posted
- 14 Aug 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.
Regardless of age, the quality of hospital care, the confidence that the young can have in the health care team, joining parents are pivotal elements and influence followed. Family support is all the more important as 14% of young people realize a new suicidal act within three months of hospitalization for attempted suicide, and that the essential predictors appear to be the young age and quality of intra-family relationships.
The main objective of this study is to determine, through the construction of an instrument to quantify the therapeutic alliance, defined by the characteristics of the mobilization of the entourage and the mutual commitments in the care of nursing teams and the entourage, the role of early therapeutic alliance with the entourage of suicidal youth 13-40 years, whether primosuicidants or repeat offenders, on short and medium term recurrences and early mortality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapetic alliance | Other | Other: Therapeutic alliance |
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patient aged 13-40 years
- From male or female
- Supported the waning of a suicidal gesture.
- speaking and writing fluent French
- living in Upper or Lower Normandy
Key exclusion criteria (8 listed)
- Age <13 years or > 40 years
- Do not live in the Upper and Lower Normandy regions
- Detained patient
- forced hospitalization
- Patient under guardianship
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 |
|---|---|---|
| Therapeutic alliance | Other | Therapetic alliance |
Primary outcome
characteristics of the mobilization of the entourage evaluated with Family Assessment Device
Time frame: baseline
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 14 Aug 2015.
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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 Therapeutic alliance in people with Suicide, run by University Hospital, Caen 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 6 inclusion and 8 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 14 Aug 2015. 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?
characteristics of the mobilization of the entourage evaluated with Family Assessment Device (time frame: baseline). 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 14 Aug 2015.