Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT02762734 Statut inconnu

Titre

Multicenter Randomized Prevention Trial of Recurrence of Suicide Attempt by Adolescent by Sending SMS (MEDIACONNEX) (MEDIACONNEX)

Type

Interventional

Pathologie

Récidive
Suicide
Tentative de suicide

Phase

N/A

Promoteur

Central Hospital, Nancy, France (Voir sur ClinicalTrials)

Date de début

février 2017

Date de fin

février 2021

Dernière mise à jour

29 juin 2024

Résumé

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.

Détail

Voir le détail 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. Fermer le détail

Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Psychothérapique de Nancy - 54511 - Vandœuvre-lès-Nancy - France	LIGIER MEDIACONNEX, Dr.	En recrutement	Contact (sur clinicalTrials)
CHRU Besançon - 25000 - Besançon - France	Sylvie NEZELOF, Pr.	En recrutement	Contact (sur clinicalTrials)
Hôpital de Mercy. CHR de Metz-Thionville - 57085 - Metz - France	Pascal PANNETIER, Dr.	En recrutement	Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Chu Reims - 51092 - Reims - France	Romain BOUILLOT, Dr.	En recrutement	Contact (sur clinicalTrials)
Hopitaux Universitaires de Strasbourg - 67200 - Strasbourg - France	Julie ROLLING, Dr.	En recrutement	Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- 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.

Critère de non inclusion

- 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.

NCT02762734 - Multicenter Randomized Prevention Trial of Recurrence of Suicide Attempt by Adolescent by Sending SMS (MEDIACONNEX) (MEDIACONNEX)

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