NCT02762734

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

February 13, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

May 3, 2016

Last Update Submit

August 22, 2019

Conditions

Keywords

adolescentsuicide

Outcome Measures

Primary Outcomes (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.

    6 months

Secondary Outcomes (4)

  • Social Support

    6 months

  • Quality of life

    6 months

  • Depression

    6 months

  • Delay of recurrence of suicide attempt

    6 to 12 months after suicide attempt

Study Arms (2)

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.

Other: MEDIA

CLASSIC

NO INTERVENTION

The patient will benefit of the usual care.

Interventions

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.

MEDIA

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • be treated for a suicide attempt
  • be 13-17 years old
  • have consent of patient and his/her parents to participation in research.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHRU Besançon

Besançon, 25000, France

RECRUITING

Hôpital de Mercy. CHR de Metz-Thionville

Metz, 57085, France

RECRUITING

Chu Reims

Reims, 51092, France

RECRUITING

Hopitaux Universitaires de Strasbourg

Strasbourg, 67200, France

RECRUITING

Centre Psychothérapique de Nancy

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

Related Publications (36)

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MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Fabienne LIGIER, Dr

    Service de Psychiatrie de l'enfant et de l'adolescent, CHRU de Nancy

    STUDY DIRECTOR
  • Catherine PICHENÉ, Dr

    CPN, Unité d'Accueil des Urgences Psychiatriques

    PRINCIPAL INVESTIGATOR
  • Philippe CHABERT, Dr

    Unité de psychopathologie de l'adolescent Service Psychothérapique pour enfants et adolescents Pôle de Psychiatrie et Santé Mentale Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR
  • Sylvie NEZELOF, Dr

    Service de Pédopsychiatrie Hôpital Jean Minjoz. CHRU de Besançon

    PRINCIPAL INVESTIGATOR
  • Pascal PANNETIER, Dr

    Service de Psychiatrie d'Urgence et de Liaison, dans les locaux du CHR Metz-Thionville Hôpital Mercy. CHR Metz-Thionville

    PRINCIPAL INVESTIGATOR
  • Jean-Michel PINOIT, Dr

    Service de Psychiatrie de l'enfant et de l'adolescent Hôpital d'enfants. CHU de Dijon

    PRINCIPAL INVESTIGATOR
  • Anne-Catherine ROLLAND, Dr

    Service de Psychothérapie de l'enfant et de l'adolescent Hôpital Robert Debré. CHU de Reims

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francis GUILLEMIN, Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 5, 2016

Study Start

February 13, 2017

Primary Completion

February 1, 2020

Study Completion

February 1, 2021

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Study results will be restituted to each participant if they ask for it.

Locations