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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Francis GUILLEMIN, Prof contact

+33383852165

francis.guillemin@chru-nancy.fr

5 sites in 1 country

France5 sites, 5 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.

    Recruiting

Other trials in France

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 groups in NCT02762734
Study groupRoleWhat they receive
MEDIAExperimentalThe 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
CLASSICNo interventionThe patient will benefit of the usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted5 May 2016 (estimated)
  2. Study start13 Feb 2017
  3. Primary completionFeb 2020 (estimated)
  4. Study completionFeb 2021 (estimated)

Resources

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)
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 12446536
  • Moran 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 22100201
  • Wong 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 17919796
  • Miranda 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 18174823
  • Thompson 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 21402269
  • MacDonald 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 19272640
  • Ligier 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 26073674
  • Vaiva 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 21618769
  • Davidson 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 17032158
  • Linehan 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 16818865
  • Weinberg 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 17032160
  • Bateman 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 10518167
  • Evans 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 10077290
  • Motto 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

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.

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