跳至主要内容
临床试验/NCT02762734
NCT02762734Unknown不适用

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

Central Hospital, Nancy, France5 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2017年2月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
225
试验地点
5
主要终点
Delay of recurrence of suicide attempt

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: MEDIA (Other)

CLASSIC

No Intervention

The patient will benefit of the usual care.

结局指标

主要结局

Delay of recurrence of suicide attempt

时间窗: 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.

次要结局

  • Delay of recurrence of suicide attempt(6 to 12 months after suicide attempt)
  • Social Support(6 months)
  • Depression(6 months)
  • Quality of life(6 months)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (5)

Loading locations...

相似试验