SuicideMEDIACONNEXNCT02762734
Prevention of Recurrence of Suicide Attempt by Adolescent by Sending SMS (MEDIACONNEX)
A study testing MEDIA in people with Suicide, run by Central Hospital, Nancy, France at 5 sites in France.
Trial summary
MEDIACONNEX study propose a new way of connectedness for adolescents after a suicide attempt: it is based on the sending of SMS (or mail or other new media), over a period of 6 months after their suicide attempt (SA), in order to allow them to recourse to the care more easily and so to limit the risk of suicidal… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Suicide
- What is being tested?
- MEDIA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 5 sitesFrance
- Study dates
- 13 Feb 2017to Feb 2021
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- be treated for a suicide attempt
- be 13-17 years old
- Patient living in the inter region or being able to be reorientated in the center of inclusion in case of recurrence of suicide attemps
- have consent of patient and his/her parents to participation in research.
Who cannot join
- The parents or/and patient who will refuse or who won't be able to accept to participate (somatic or understandability reasons),
- Incarcerated patient
- Those without any cell phone.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHRU Besançon
Besançon, 25000
Sylvie NEZELOF, Pr.
- Recruiting
Hôpital de Mercy. CHR de Metz-Thionville
Metz, 57085
Pascal PANNETIER, Dr.
- Recruiting
Chu Reims
Reims, 51092
Romain BOUILLOT, Dr.
- Recruiting
Hopitaux Universitaires de Strasbourg
Strasbourg, 67200
Julie ROLLING, Dr.
- Recruiting
Centre Psychothérapique de Nancy
Vandœuvre-lès-Nancy, 54511
LIGIER MEDIACONNEX, Dr.
About this study
Official title: Multicenter Randomized Prevention Trial of Recurrence of Suicide Attempt by Adolescent by Sending SMS (MEDIACONNEX)
MEDIACONNEX study propose a new way of connectedness for adolescents after a suicide attempt: it is based on the sending of SMS (or mail or other new media), over a period of 6 months after their suicide attempt (SA), in order to allow them to recourse to the care more easily and so to limit the risk of suicidal recurrence. The MEDIACONNEX study will be a multicenter controlled randomized trial (East of France) and there is a funding from the Hospital. The proposal trial will test the hypothesis that adolescent suicide attempters who are receiving SMS (or mail or other new media) from the unit of care in addition to the usual care will do less SA recurrence, than those who are receiving the usual care.
The primary objective is to determine whether the use of SMS (or mail or other new media) to keep in touch with adolescent suicide attempters in addition to the usual care, compare to usual care, will reduce the delay of recurrence of suicide attempt during 6 months after the SA.
Read the detailed description
In industrialised countries, the incidence of SA among adolescents (ages 10-19 years old; 1) is estimated between 7% and 9% (2-3). Thirty percent of adolescents who have made a SA will do it again in the year. It appears that previous SA is "an independent and powerful predictor of futur attempt" (4). Moreover, one of the risk factors to commit suicide is to have made a SA, in particular during year preceding the suicide. To prevent suicide, it is thus important to prevent SA and particularly their recurrence. Research on adolescent suicide attempters focus in general on risk or protective factors (5-7). But despite of the knowledge on these characteristics, the rate of SA recurrence doesn't decrease. So, we have to be creative in the care proposals to limit it. An earlier study concluded that when adolescent suicide attempters were not any more in contact with the care system, they had more risk for SA recurrence (8). These last decades, news ways of care to prevent SA recurrence are developing for adults' suicide attempters on. These news cares may be divided into 2 categories: the "intensive cares" and the "connectedness" care (9). The intensive cares are for example specific therapies as cognitive-behaviour-therapy or dialectical behavior therapy (10-12), partial hospitalizations (13), brief psychological intervention at patients 'home (14)... And with some of these treatments, the rate or recurrence decreased (11-13). The "connectedness cares" are based on the fact of "keeping in touch" with patients and encouraging them to call in case of crises in order to avoid the recurrence. Motto and al. were the pioneer in the field of the connectedness in the 70s through the sending of letters regularly after the suicide attempt (15). It might be also through the sending of postcards (16-17), phone calls (18-19) or SMS (20)… As the intensive cares, these cares may have positive results on the rate of recurrence or on the numbers of recurrences. By the way, these different cares have diverse results depending sex or personality of patients (21). There is so a clinical relevance with the both sorts of cares but the "connectedness" one is easier to use, have a low cost and moreover, seems more appropriate for adolescents. Indeed, the therapeutic alliance with the young patients is not easy to install and an "intensive care" might be prevent them joining the care. Moreover, in another study in Nancy, France, the fact of being lost to follow-up by the caregivers is appeared as a risk factor of recurrence, even in 10-year after the suicide attempt. So, the fact of "keeping in touch" with adolescents after a suicide attempt is very important and they probably could accept easily this idea through one media they often use: short message system (SMS). There are yet some MobilHealth programs for adolescents as for adults in other specialties with good results (22-24).
MEDIACONNEX study also propose to assess the effectiveness of a new way of connectedness for adolescents after a SA : it is based on the sending of SMS (or mail or other new media), over a period of 6 months after their suicide attempt, in order to allow them to recourse to the care more easily and so to limit the risk of suicidal recurrence.
Design The MEDIACONNEX study is a simple blind, parallel group multisite randomized controlled trial which compares a program based on SMS (or mail or other new media) in addition to usual care (group MEDIA) to "only usual care" (group CLASSIC) provided to adolescents who attempted suicide and who were treated in-child and adolescent psychiatry unit at hospitals in the East of France. The comparison is based on rate of the recurrence suicide attempt between the two groups.
The primary objective is to determine whether the use of SMS (or mail or other new media) to keep in touch with adolescent suicide attempters in addition to the usual care, compare to usual care, will reduce the delay of recurrence of suicide attempt during 6 months after the SA.
Secondary objectives:
Determine whether the use of SMS (or mail or other new media) to keep in touch with adolescent suicide attempters in addition to the usual care, compare to usual care, will improve the evolution of their social network during 6 months Determine whether the use of SMS (or mail or other new media) to keep in touch with adolescent suicide attempters in addition to the usual care, compare to usual care, will improve the evolution of depression during 6 months Determine whether the use of SMS (or mail or other new media) to keep in touch with adolescent suicide attempters in addition to the usual care, compare to usual care, will improve the evolution of health-related quality of life during 6 months Determine the delay of recurrence of suicide attempt during 6 months after the end of the intervention by sending SMS (or mail or other new media) to evaluate if the intervention has an effect on the recurrence after stopped Determine the delay of death by suicide during 6 months after the end of the intervention by sending SMS (or mail or other new media) to evaluate if the intervention has an effect on the suicide after stopped Compare number of callphone spent in the unit of care between adolescents of the group Media and those of the group Classic
Participants Adolescent treated after a suicide attempt in a pediatric or psychiatric unit of the participating hospitals: Besançon, Dijon, Metz-Thionville, Nancy, Reims, and Strasbourg, FRANCE. The SA is defined as "a non-fatal act in which the individual liberally causes self-injury or ingests a substance in excess of any prescribed or generally recognised therapeutic dosage" (25). All the patients have a medical examination before the beginning of the research. Adolescent will be recruited during a psychiatric evaluation within 24 hours of admission to pediatric unit of the participating hospitals.
Inclusion Criteria:
To be 13-17 years old To be treated for a suicide attempt To have written consent of patient and his/her parents to participation in research
Non-inclusion Criteria:
The parents or/and patient who will refuse or who won't be able to accept to participate (somatic or understandability reasons), Incarcerated patient Those without any cell phone or any internet connexion or other new media.
Randomization The Zelen randomization will be used for this study (26-28). In each participating hospital, a member of the research team will screen each adolescent suicide attempters and when the adolescent suicide attempter will meet the eligibility criteria, his/her group for the study will be defined by a randomization. This patient will benefit of the usual care with additional SMS (group MEDIA) or of the usual care (group CLASSIC). Then, this member of the research will inform the adolescent 'psychiatrist who will present to the patient and his/her parents the design of the study, only for the group of the patient. The psychiatrist will also give information about the study and will gather an "informed consent".
Intervention The intervention for the group MEDIA is a "keeping in touch" intervention through sending of SMS (or mail or other new media). The patient will receive 6 SMS (or mail or other new media) during 6 months after the SA. The first one 7 days after the SA and the last one after 6 months. The first SMS (or mail or other new media) is sent soon after the SA because studies on adult suicide attempters underline the importance of an early start for the connectedness measures. The text messages are evolving in time, and are adapted to the genre of the adolescent.
The control arm is represented by the group CLASSIC with usual care.
Outcome measures Primary outcome The primary outcome is the delay of recurrence of suicide attempt during 6 months after the inclusion in the study. The recurrence and its date of occurrence will be collected by a member of the research team in each participating hospital.
Secondary outcomes The secondary outcomes include evaluation and evolution in a 6-month period after the SA of adolescent' social network using the Multidimensional Scale of Perceived Social Support (MSPSS), evaluation and evolution in a 6-month period after the SA of adolescent health-related quality of life using Kidscreen-27 and VSP-A, and evolution in a 6-month period after the SA of adolescent' depression using Center for Epidemiologic Studies Depression Scale (CES-D). The scores and their evolution will be compared between the groups CLASSIC and MEDIA.
The delay of recurrence of suicide attempt during 6 months after the end of the intervention by sending SMS (or mail or other new media). The recurrence and its date of occurrence will be collected by a member of the research team in each participating hospital.
The delay of death by suicide during 6 months after the end of the intervention. The suicide and its date of occurrence will be collected by a member of the research team in each participating hospital.
The number of callphone spent in the unit of care between adolescents of the group Media and those of the group Classic. They will be noted in a notebook planned for that purpose.
Instruments The text messages have been worked in focus group of peers and with adolescents. A pilot study has also been carried out in 2015 (MEDIADO) to refine their content. The text messages will be changing over time. They will be personalized with the surname of the patient and the name of the psychiatrist or his/her immediate superior who has met the patient after the SA. The number of the unit will be underlined in the message and the patient will be encouraged to call whenever he/she will feel the need to do it and will specify that someone will be always present for him/her.
The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item self-report with 5 possible answers by item. It assesses perceptions of social support from family members, friends, and significant others. It has been already used in other countries (29-30) and has been translated and validated in French by a team of Toulouse (31). The three subscales, each addressing a different source of support, were identified and found to have strong factorial validity. The MSPSS had also a good internal and test-retest reliability as well as moderate construct validity. High levels of perceived social support are associated with low levels of depression and anxiety.
The Kidscreen-27 is a 27-item self-report developed by an European group (32), validated in 12 European countries. It evaluates physical wellness, psychological wellness, relationships with parents, social network, relationships with friends, and schooling. The internal consistency is good as the discriminating power.
The VSP-A is a 37-item self-report with 10 dimensions, validated in French. This self-report has a good internal consistency as its construct validity and its content validity are also good (33).
The CES-D is a 12-item self report with a good internal consistency, validated in French.
The baseline personal, familial and social characteristics will be collected from medical records in order to explore factors that influence outcomes.
Statistical analyses The primary analyses will be conducted on an intention-to-treat basis using data for all randomized participants, although a per protocol analysis of the primary outcome will also be reported. There will be adjusted on the center. Continuous variables will be described with mean (and standard deviation) or median (and range), and categorical variables with number and percentage, as appropriate. The Chi-square or Fisher exact tests will be used for analysis of qualitative variables and the Student t or Mann-Whitney tests for quantitative variables.
Differences in both primary and secondary outcomes between the two groups of the study will be tested independently.
- Conditions
- Suicide
- Being tested
- MEDIA
- Keywords
- adolescent, suicide
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDIAOther
The intervention for the group MEDIA is a "keeping in touch" intervention through sending of SMS (or mail or other new media). The patient will receive 6 SMS (or mail or other new media) during 6 months after the suicide attempt. The first one 7 days after the suicide attempt and the last one after 6 months. The first SMS (or mail or other new media) is sent soon after the suicide attempt because studies on adult suicide attempters underline the importance of an early start for the connectedness measures. The text message are evolving in time, and are adapted to the genre of the adolescent.
| Study group | Role | What they receive |
|---|---|---|
| MEDIA | Experimental | The patient will benefit of the usual care with additional text message (SMS or mail or other new media). The intervention for the group MEDIA is a "keeping in touch" intervention through sending of SMS (or mail or other new media). The patient will receive 6 SMS (or mail or other new media) during 6 months after the suicide attempt. Receives: Other: MEDIA |
| CLASSIC | No intervention | The patient will benefit of the usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay of recurrence of suicide attempt
The primary outcome is the delay of recurrence of suicide attempt during 6 months after the inclusion in the study. The recurrence and its date of occurrence will be collected by a member of the research team in each participating hospital.
Measured: 6 months
Secondary outcomes (4)
Social Support
Evaluation and evolution in a 6-month period after the suicide attempt of adolescent' social network using the Multidimensional Scale of Perceived Social Support (MSPSS)
Measured: 6 months
Quality of life
Evaluation and evolution in a 6-month period after the suicide attempt of adolescent health-related quality of life using Kidscreen-27 and VSP-A
Measured: 6 months
Depression
Evaluation and evolution in a 6-month period after the suicide attempt of adolescent' depression using Center for Epidemiologic Studies Depression Scale (CES-D)
Measured: 6 months
Delay of recurrence of suicide attempt
Delay of recurrence of suicide attempt during 6 to 12 months after the inclusion in the study. The recurrence and its date of occurrence will be collected by a member of the research team in each participating hospital.
Measured: 6 to 12 months after suicide attempt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study start13 Feb 2017
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne LIGIER, Dr, Study director, Service de Psychiatrie de l'enfant et de l'adolescent, CHRU de NancyCatherine PICHENÉ, Dr, Principal investigator, CPN, Unité d'Accueil des Urgences PsychiatriquesPhilippe CHABERT, Dr, Principal investigator, Unité de psychopathologie de l'adolescent Service Psychothérapique pour enfants et adolescents Pôle de Psychiatrie et Santé Mentale Hôpitaux Universitaires de StrasbourgSylvie NEZELOF, Dr, Principal investigator, Service de Pédopsychiatrie Hôpital Jean Minjoz. CHRU de BesançonPascal PANNETIER, Dr, Principal investigator, Service de Psychiatrie d'Urgence et de Liaison, dans les locaux du CHR Metz-Thionville Hôpital Mercy. CHR Metz-ThionvilleJean-Michel PINOIT, Dr, Principal investigator, Service de Psychiatrie de l'enfant et de l'adolescent Hôpital d'enfants. CHU de DijonAnne-Catherine ROLLAND, Dr, Principal investigator, Service de Psychothérapie de l'enfant et de l'adolescent Hôpital Robert Debré. CHU de Reims
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762734
- Sponsor's protocol ID
- 2015-A00744-45
- Acronym
- MEDIACONNEX
- Status last verified
- Aug 2019
- First submitted
- 3 May 2016
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study results will be restituted to each participant if they ask for it.
Publications
1. World Health Organization WHO. (2011). http://www.who.int/maternal_child_adolescent/topics/adolescence/fr/ Accessed April 2016
Hawton K, Rodham K, Evans E, Weatherall R. Deliberate self harm in adolescents: self report survey in schools in England. BMJ. 2002 Nov 23;325(7374):1207-11. doi: 10.1136/bmj.325.7374.1207.
PubMed 12446536Moran P, Coffey C, Romaniuk H, Olsson C, Borschmann R, Carlin JB, Patton GC. The natural history of self-harm from adolescence to young adulthood: a population-based cohort study. Lancet. 2012 Jan 21;379(9812):236-43. doi: 10.1016/S0140-6736(11)61141-0. Epub 2011 Nov 16.
PubMed 22100201Wong JP, Stewart SM, Claassen C, Lee PW, Rao U, Lam TH. Repeat suicide attempts in Hong Kong community adolescents. Soc Sci Med. 2008 Jan;66(2):232-41. doi: 10.1016/j.socscimed.2007.08.031. Epub 2007 Oct 4.
PubMed 17919796Miranda R, Scott M, Hicks R, Wilcox HC, Harris Munfakh JL, Shaffer D. Suicide attempt characteristics, diagnoses, and future attempts: comparing multiple attempters to single attempters and ideators. J Am Acad Child Adolesc Psychiatry. 2008 Jan;47(1):32-40. doi: 10.1097/chi.0b013e31815a56cb.
PubMed 18174823Thompson MP, Light LS. Examining gender differences in risk factors for suicide attempts made 1 and 7 years later in a nationally representative sample. J Adolesc Health. 2011 Apr;48(4):391-7. doi: 10.1016/j.jadohealth.2010.07.018. Epub 2010 Oct 8.
PubMed 21402269MacDonald R, Taylor J, Clarke D. The relationship between early suicide behaviors and mental health: results from a nine-year panel study. J Adolesc. 2009 Oct;32(5):1159-72. doi: 10.1016/j.adolescence.2009.01.012. Epub 2009 Mar 9.
PubMed 19272640Ligier F, Guillemin F, Angot C, Bourion S, Kabuth B. Recurrence of suicide attempt in adolescents lost to contact early by clinicians: The 10-year REPEATERS cohort of French adolescents. J Adolesc. 2015 Aug;43:111-8. doi: 10.1016/j.adolescence.2015.05.011. Epub 2015 Jun 12.
PubMed 26073674Vaiva G, Jardon V, Vaillant A, Ducrocq F. [What can we do to prevent the suicide re-attempts?]. Rev Prat. 2011 Feb;61(2):202-3, 206-7. French.
PubMed 21618769Davidson K, Norrie J, Tyrer P, Gumley A, Tata P, Murray H, Palmer S. The effectiveness of cognitive behavior therapy for borderline personality disorder: results from the borderline personality disorder study of cognitive therapy (BOSCOT) trial. J Pers Disord. 2006 Oct;20(5):450-65. doi: 10.1521/pedi.2006.20.5.450.
PubMed 17032158Linehan MM, Comtois KA, Murray AM, Brown MZ, Gallop RJ, Heard HL, Korslund KE, Tutek DA, Reynolds SK, Lindenboim N. Two-year randomized controlled trial and follow-up of dialectical behavior therapy vs therapy by experts for suicidal behaviors and borderline personality disorder. Arch Gen Psychiatry. 2006 Jul;63(7):757-66. doi: 10.1001/archpsyc.63.7.757.
PubMed 16818865Weinberg I, Gunderson JG, Hennen J, Cutter CJ Jr. Manual assisted cognitive treatment for deliberate self-harm in borderline personality disorder patients. J Pers Disord. 2006 Oct;20(5):482-92. doi: 10.1521/pedi.2006.20.5.482.
PubMed 17032160Bateman A, Fonagy P. Effectiveness of partial hospitalization in the treatment of borderline personality disorder: a randomized controlled trial. Am J Psychiatry. 1999 Oct;156(10):1563-9. doi: 10.1176/ajp.156.10.1563.
PubMed 10518167Evans K, Tyrer P, Catalan J, Schmidt U, Davidson K, Dent J, Tata P, Thornton S, Barber J, Thompson S. Manual-assisted cognitive-behaviour therapy (MACT): a randomized controlled trial of a brief intervention with bibliotherapy in the treatment of recurrent deliberate self-harm. Psychol Med. 1999 Jan;29(1):19-25. doi: 10.1017/s003329179800765x.
PubMed 10077290Motto JA, Bostrom AG. A randomized controlled trial of postcrisis suicide prevention. Psychiatr Serv. 2001 Jun;52(6):828-33. doi: 10.1176/appi.ps.52.6.828.
PubMed 11376235
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Prevention Trial of Recurrence of Suicide Attempt by Adolescent by Sending SMS (MEDIACONNEX)
- ClinicalTrials.gov ID
- NCT02762734
- Acronym / sponsor ID
- MEDIACONNEX / 2015-A00744-45
- Conditions
- Suicide
- Keywords
- adolescent, suicide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 5 May 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.
MEDIACONNEX study propose a new way of connectedness for adolescents after a suicide attempt: it is based on the sending of SMS (or mail or other new media), over a period of 6 months after their suicide attempt (SA), in order to allow them to recourse to the care more easily and so to limit the risk of suicidal recurrence. The MEDIACONNEX study will be a multicenter controlled randomized trial (East of France) and there is a funding from the Hospital. The proposal trial will test the hypothesis that adolescent suicide attempters who are receiving SMS (or mail or other new media) from the unit of care in addition to the usual care will do less SA recurrence, than those who are receiving the usual care.
The primary objective is to determine whether the use of SMS (or mail or other new media) to keep in touch with adolescent suicide attempters in addition to the usual care, compare to usual care, will reduce the delay of recurrence of suicide attempt during 6 months after the SA.
Detailed description
In industrialised countries, the incidence of SA among adolescents (ages 10-19 years old; 1) is estimated between 7% and 9% (2-3). Thirty percent of adolescents who have made a SA will do it again in the year. It appears that previous SA is "an independent and powerful predictor of futur attempt" (4). Moreover, one of the risk factors to commit suicide is to have made a SA, in particular during year preceding the suicide. To prevent suicide, it is thus important to prevent SA and particularly their recurrence. Research on adolescent suicide attempters focus in general on risk or protective factors (5-7). But despite of the knowledge on these characteristics, the rate of SA recurrence doesn't decrease. So, we have to be creative in the care proposals to limit it. An earlier study concluded that when adolescent suicide attempters were not any more in contact with the care system, they had more risk for SA recurrence (8). These last decades, news ways of care to prevent SA recurrence are developing for adults' suicide attempters on. These news cares may be divided into 2 categories: the "intensive cares" and the "connectedness" care (9). The intensive cares are for example specific therapies as cognitive-behaviour-therapy or dialectical behavior therapy (10-12), partial hospitalizations (13), brief psychological intervention at patients 'home (14)... And with some of these treatments, the rate or recurrence decreased (11-13). The "connectedness cares" are based on the fact of "keeping in touch" with patients and encouraging them to call in case of crises in order to avoid the recurrence. Motto and al. were the pioneer in the field of the connectedness in the 70s through the sending of letters regularly after the suicide attempt (15). It might be also through the sending of postcards (16-17), phone calls (18-19) or SMS (20)… As the intensive cares, these cares may have positive results on the rate of recurrence or on the numbers of recurrences. By the way, these different cares have diverse results depending sex or personality of patients (21). There is so a clinical relevance with the both sorts of cares but the "connectedness" one is easier to use, have a low cost and moreover, seems more appropriate for adolescents. Indeed, the therapeutic alliance with the young patients is not easy to install and an "intensive care" might be prevent them joining the care. Moreover, in another study in Nancy, France, the fact of being lost to follow-up by the caregivers is appeared as a risk factor of recurrence, even in 10-year after the suicide attempt. So, the fact of "keeping in touch" with adolescents after a suicide attempt is very important and they probably could accept easily this idea through one media they often use: short message system (SMS). There are yet some MobilHealth programs for adolescents as for adults in other specialties with good results (22-24).
MEDIACONNEX study also propose to assess the effectiveness of a new way of connectedness for adolescents after a SA : it is based on the sending of SMS (or mail or other new media), over a period of 6 months after their suicide attempt, in order to allow them to recourse to the care more easily and so to limit the risk of suicidal recurrence.
Design The MEDIACONNEX study is a simple blind, parallel group multisite randomized controlled trial which compares a program based on SMS (or mail or other new media) in addition to usual care (group MEDIA) to "only usual care" (group CLASSIC) provided to adolescents who attempted suicide and who were treated in-child and adolescent psychiatry unit at hospitals in the East of France. The comparison is based on rate of the recurrence suicide attempt between the two groups.
The primary objective is to determine whether the use of SMS (or mail or other new media) to keep in touch with adolescent suicide attempters in addition to the usual care, compare to usual care, will reduce the delay of recurrence of suicide attempt during 6 months after the SA.
Secondary objectives:
Determine whether the use of SMS (or mail or other new media) to keep in touch with adolescent suicide attempters in addition to the usual care, compare to usual care, will improve the evolution of their social network during 6 months Determine whether the use of SMS (or mail or other new media) to keep in touch with adolescent suicide attempters in addition to the usual care, compare to usual care, will improve the evolution of depression during 6 months Determine whether the use of SMS (or mail or other new media) to keep in touch with adolescent suicide attempters in addition to the usual care, compare to usual care, will improve the evolution of health-related quality of life during 6 months Determine the delay of recurrence of suicide attempt during 6 months after the end of the intervention by sending SMS (or mail or other new media) to evaluate if the intervention has an effect on the recurrence after stopped Determine the delay of death by suicide during 6 months after the end of the intervention by sending SMS (or mail or other new media) to evaluate if the intervention has an effect on the suicide after stopped Compare number of callphone spent in the unit of care between adolescents of the group Media and those of the group Classic
Participants Adolescent treated after a suicide attempt in a pediatric or psychiatric unit of the participating hospitals: Besançon, Dijon, Metz-Thionville, Nancy, Reims, and Strasbourg, FRANCE. The SA is defined as "a non-fatal act in which the individual liberally causes self-injury or ingests a substance in excess of any prescribed or generally recognised therapeutic dosage" (25). All the patients have a medical examination before the beginning of the research. Adolescent will be recruited during a psychiatric evaluation within 24 hours of admission to pediatric unit of the participating hospitals.
Inclusion Criteria:
To be 13-17 years old To be treated for a suicide attempt To have written consent of patient and his/her parents to participation in research
Non-inclusion Criteria:
The parents or/and patient who will refuse or who won't be able to accept to participate (somatic or understandability reasons), Incarcerated patient Those without any cell phone or any internet connexion or other new media.
Randomization The Zelen randomization will be used for this study (26-28). In each participating hospital, a member of the research team will screen each adolescent suicide attempters and when the adolescent suicide attempter will meet the eligibility criteria, his/her group for the study will be defined by a randomization. This patient will benefit of the usual care with additional SMS (group MEDIA) or of the usual care (group CLASSIC). Then, this member of the research will inform the adolescent 'psychiatrist who will present to the patient and his/her parents the design of the study, only for the group of the patient. The psychiatrist will also give information about the study and will gather an "informed consent".
Intervention The intervention for the group MEDIA is a "keeping in touch" intervention through sending of SMS (or mail or other new media). The patient will receive 6 SMS (or mail or other new media) during 6 months after the SA. The first one 7 days after the SA and the last one after 6 months. The first SMS (or mail or other new media) is sent soon after the SA because studies on adult suicide attempters underline the importance of an early start for the connectedness measures. The text messages are evolving in time, and are adapted to the genre of the adolescent.
The control arm is represented by the group CLASSIC with usual care.
Outcome measures Primary outcome The primary outcome is the delay of recurrence of suicide attempt during 6 months after the inclusion in the study. The recurrence and its date of occurrence will be collected by a member of the research team in each participating hospital.
Secondary outcomes The secondary outcomes include evaluation and evolution in a 6-month period after the SA of adolescent' social network using the Multidimensional Scale of Perceived Social Support (MSPSS), evaluation and evolution in a 6-month period after the SA of adolescent health-related quality of life using Kidscreen-27 and VSP-A, and evolution in a 6-month period after the SA of adolescent' depression using Center for Epidemiologic Studies Depression Scale (CES-D). The scores and their evolution will be compared between the groups CLASSIC and MEDIA.
The delay of recurrence of suicide attempt during 6 months after the end of the intervention by sending SMS (or mail or other new media). The recurrence and its date of occurrence will be collected by a member of the research team in each participating hospital.
The delay of death by suicide during 6 months after the end of the intervention. The suicide and its date of occurrence will be collected by a member of the research team in each participating hospital.
The number of callphone spent in the unit of care between adolescents of the group Media and those of the group Classic. They will be noted in a notebook planned for that purpose.
Instruments The text messages have been worked in focus group of peers and with adolescents. A pilot study has also been carried out in 2015 (MEDIADO) to refine their content. The text messages will be changing over time. They will be personalized with the surname of the patient and the name of the psychiatrist or his/her immediate superior who has met the patient after the SA. The number of the unit will be underlined in the message and the patient will be encouraged to call whenever he/she will feel the need to do it and will specify that someone will be always present for him/her.
The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item self-report with 5 possible answers by item. It assesses perceptions of social support from family members, friends, and significant others. It has been already used in other countries (29-30) and has been translated and validated in French by a team of Toulouse (31). The three subscales, each addressing a different source of support, were identified and found to have strong factorial validity. The MSPSS had also a good internal and test-retest reliability as well as moderate construct validity. High levels of perceived social support are associated with low levels of depression and anxiety.
The Kidscreen-27 is a 27-item self-report developed by an European group (32), validated in 12 European countries. It evaluates physical wellness, psychological wellness, relationships with parents, social network, relationships with friends, and schooling. The internal consistency is good as the discriminating power.
The VSP-A is a 37-item self-report with 10 dimensions, validated in French. This self-report has a good internal consistency as its construct validity and its content validity are also good (33).
The CES-D is a 12-item self report with a good internal consistency, validated in French.
The baseline personal, familial and social characteristics will be collected from medical records in order to explore factors that influence outcomes.
Statistical analyses The primary analyses will be conducted on an intention-to-treat basis using data for all randomized participants, although a per protocol analysis of the primary outcome will also be reported. There will be adjusted on the center. Continuous variables will be described with mean (and standard deviation) or median (and range), and categorical variables with number and percentage, as appropriate. The Chi-square or Fisher exact tests will be used for analysis of qualitative variables and the Student t or Mann-Whitney tests for quantitative variables.
Differences in both primary and secondary outcomes between the two groups of the study will be tested independently.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEDIA | Experimental | Other: MEDIAThe patient will benefit of the usual care with additional text message (SMS or mail or other new media). The intervention for the group MEDIA is a "keeping in touch" intervention through sending of SMS (or mail or other new media). The patient will receive 6 SMS (or mail or other new media) during 6 months after the suicide attempt. |
| CLASSIC | No intervention | –The patient will benefit of the usual care. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- be treated for a suicide attempt
- be 13-17 years old
- Patient living in the inter region or being able to be reorientated in the center of inclusion in case of recurrence of suicide attemps
- have consent of patient and his/her parents to participation in research.
Key exclusion criteria (3 listed)
- The parents or/and patient who will refuse or who won't be able to accept to participate (somatic or understandability reasons),
- Incarcerated patient
- Those without any cell phone.
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 |
|---|---|---|
| MEDIAThe intervention for the group MEDIA is a "keeping in touch" intervention through sending of SMS (or mail or other new media). The patient will receive 6 SMS (or mail or other new media) during 6 months after the suicide attempt. The first one 7 days after the suicide attempt and the last one after 6 months. The first SMS (or mail or other new media) is sent soon after the suicide attempt because studies on adult suicide attempters underline the importance of an early start for the connectedness measures. The text message are evolving in time, and are adapted to the genre of the adolescent. | Other | MEDIA |
Primary outcome
Delay of recurrence of suicide attempt
Time frame: 6 months
The primary outcome is the delay of recurrence of suicide attempt during 6 months after the inclusion in the study. The recurrence and its date of occurrence will be collected by a member of the research team in each participating hospital.
4 secondary outcomes
Social Support
Time frame: 6 months
Quality of life
Time frame: 6 months
Depression
Time frame: 6 months
Delay of recurrence of suicide attempt
Time frame: 6 to 12 months after suicide attempt
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Background1. World Health Organization WHO. (2011). http://www.who.int/maternal_child_adolescent/topics/adolescence/fr/ Accessed April 2016
- Background: PubMed 12446536Hawton K, Rodham K, Evans E, Weatherall R. Deliberate self harm in adolescents: self report survey in schools in England. BMJ. 2002 Nov 23;325(7374):1207-11. doi: 10.1136/bmj.325.7374.1207.
- Background: PubMed 22100201Moran P, Coffey C, Romaniuk H, Olsson C, Borschmann R, Carlin JB, Patton GC. The natural history of self-harm from adolescence to young adulthood: a population-based cohort study. Lancet. 2012 Jan 21;379(9812):236-43. doi: 10.1016/S0140-6736(11)61141-0. Epub 2011 Nov 16.
- Background: PubMed 17919796Wong JP, Stewart SM, Claassen C, Lee PW, Rao U, Lam TH. Repeat suicide attempts in Hong Kong community adolescents. Soc Sci Med. 2008 Jan;66(2):232-41. doi: 10.1016/j.socscimed.2007.08.031. Epub 2007 Oct 4.
- Background: PubMed 18174823Miranda R, Scott M, Hicks R, Wilcox HC, Harris Munfakh JL, Shaffer D. Suicide attempt characteristics, diagnoses, and future attempts: comparing multiple attempters to single attempters and ideators. J Am Acad Child Adolesc Psychiatry. 2008 Jan;47(1):32-40. doi: 10.1097/chi.0b013e31815a56cb.
- Background: PubMed 21402269Thompson MP, Light LS. Examining gender differences in risk factors for suicide attempts made 1 and 7 years later in a nationally representative sample. J Adolesc Health. 2011 Apr;48(4):391-7. doi: 10.1016/j.jadohealth.2010.07.018. Epub 2010 Oct 8.
- Background: PubMed 19272640MacDonald R, Taylor J, Clarke D. The relationship between early suicide behaviors and mental health: results from a nine-year panel study. J Adolesc. 2009 Oct;32(5):1159-72. doi: 10.1016/j.adolescence.2009.01.012. Epub 2009 Mar 9.
- Background: PubMed 26073674Ligier F, Guillemin F, Angot C, Bourion S, Kabuth B. Recurrence of suicide attempt in adolescents lost to contact early by clinicians: The 10-year REPEATERS cohort of French adolescents. J Adolesc. 2015 Aug;43:111-8. doi: 10.1016/j.adolescence.2015.05.011. Epub 2015 Jun 12.
- Background: PubMed 21618769Vaiva G, Jardon V, Vaillant A, Ducrocq F. [What can we do to prevent the suicide re-attempts?]. Rev Prat. 2011 Feb;61(2):202-3, 206-7. French.
- Background: PubMed 17032158Davidson K, Norrie J, Tyrer P, Gumley A, Tata P, Murray H, Palmer S. The effectiveness of cognitive behavior therapy for borderline personality disorder: results from the borderline personality disorder study of cognitive therapy (BOSCOT) trial. J Pers Disord. 2006 Oct;20(5):450-65. doi: 10.1521/pedi.2006.20.5.450.
- Background: PubMed 16818865Linehan MM, Comtois KA, Murray AM, Brown MZ, Gallop RJ, Heard HL, Korslund KE, Tutek DA, Reynolds SK, Lindenboim N. Two-year randomized controlled trial and follow-up of dialectical behavior therapy vs therapy by experts for suicidal behaviors and borderline personality disorder. Arch Gen Psychiatry. 2006 Jul;63(7):757-66. doi: 10.1001/archpsyc.63.7.757.
- Background: PubMed 17032160Weinberg I, Gunderson JG, Hennen J, Cutter CJ Jr. Manual assisted cognitive treatment for deliberate self-harm in borderline personality disorder patients. J Pers Disord. 2006 Oct;20(5):482-92. doi: 10.1521/pedi.2006.20.5.482.
- Individual participant dataSharing planned: No. Study results will be restituted to each participant if they ask for it.
Related trials for Suicide
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
SERENE Low-Intensity Focused Ultrasound for Cognitive Control
Suicidal Ideation, Cognitive Control
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Enrolling by invitation
Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study
Suicidal Ideation, Suicidal Behaviors
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.
Fabienne LIGIER, Dr study director
Service de Psychiatrie de l'enfant et de l'adolescent, CHRU de Nancy
Catherine PICHENÉ, Dr principal investigator
CPN, Unité d'Accueil des Urgences Psychiatriques
Philippe CHABERT, Dr principal investigator
Unité de psychopathologie de l'adolescent Service Psychothérapique pour enfants et adolescents Pôle de Psychiatrie et Santé Mentale Hôpitaux Universitaires de Strasbourg
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEDIA in people with Suicide, run by Central Hospital, Nancy, France at 5 sites 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 4 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: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabienne LIGIER, Dr (+33383154553, fabienne.ligier@cpn-laxou.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay of recurrence of suicide attempt (time frame: 6 months). 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 NCT02762734, which also lists 36 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 28 Aug 2019.