- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT06576453
Évaluation à méthodes mixtes d'un programme de psychoéducation parentale dans un groupe de prévention du risque de suicide (Pepps_Mix)
The number of emergency consultations for children and adolescents for suicidal ideation and suicide attempts has been rising steadily since 2010, and even more so since 2020. In addition, 30% of children and adolescents who have committed a suicidal act reoffend within the year.
Psycho-education programmes for patients have been shown to be effective in a large number of psychiatric pathologies. The programs of psychoeducation for the caregivers of these patients have them also shown their effectiveness, however to date there is no parental psychoeducation program group, for the prevention of the suicidal risk of children and adolescents, which is validated. The service of child psychiatry at the Robert Debré hospital built a program for this purpose, according to current data from the science and has been offering it for 6 months to parents of patients who consulted for suicidal ideation. Rate this program through the description of its implementation would allow it to be validated, this in a dissemination objective. This validation through a mixed method would also allow us to describe the experience participants in this program and to understand improvements Track.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Implementation study: non-randomized, single-center, quasi-experimental study before - after for the evaluation criteria of intermediate effectiveness (effectiveness). Study mixed qualitative-quantitative method for the evaluation of several judgment criteria.
The main objectives is to Evaluate the implementation of a parental psychoeducation program in a group of suicide prevention through parental support for the entire program.
The secondary objectives are to evaluate:
- reaching the target population (Reach)
- the intermediate effectiveness of the program
- the adoption of the program by health professionals
- the implementation on other dimensions
- the sustainability of the program
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Île-de-France Region
-
Paris, Île-de-France Region, France, 75019
- Robert Debré Hospital, Child and adolescent psychiatry department
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Parents of a child under 15 years 6 months old urgently consulted at the Robert Debré hospital for ideas suicidal or attempted suicide
La description
Inclusion Criteria:
- Parent committing to participate in the 4 sessions of the parental psychoeducation prevention program suicide risk (PEPPS program)
- Parents of children under 15 years and 6 months
- Parents fluent in French
Exclusion Criteria:
- Lack of affiliation with a social security scheme or CMU (universal health coverage)
- Parents under guardianship or curatorship
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: FAMILY_BASED
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
All of the participants
Parents participate in the PEPPS program (Parental psychoeducation program for suicide risk prevention) This is a group family psychoeducation program for parents child under 15 years 6 months having been urgently assessed at Robert University Hospital discharged for suicidal ideation or attempted suicide. This program is built according to a global model based on:
|
Parents must complete the self-questionnaire WHOQOL-bref after the first and the last session of the Pepps program. Parents must complete the self-questionnaire Evaluation Inventory - Parent after the last session of the Pepps program. Parents must complete the quiz of knowledge after the first and the last session of the Pepps program. |
|
Participants - qualitative interview
Semi-structured interviews (qualitative) will be carried out with parents who have followed either all or part of the sessions of the band. The parents interviewed will be chosen based on the wealth of information they will be likely to contribute to the study.The sampling method will follow the "snowball" model, described by Kathy Charmaz. According to this, the characteristics of new participants will be determined according to the results of the analysis of the first interviews until data saturation. We will conclude with the latter when no new information emerges from the data collection. |
Parents must complete the self-questionnaire WHOQOL-bref after the first and the last session of the Pepps program. Parents must complete the self-questionnaire Evaluation Inventory - Parent after the last session of the Pepps program. Parents must complete the quiz of knowledge after the first and the last session of the Pepps program. In the month following the last session of the program, the semi-structured interviews (qualitative) will be carried out with parents who have followed either all or part of the sessions of the band. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
implementation of a program parental psychoeducation in prevention groups suicide (program PEPPS).
Délai: Week 5
|
program membership = Number of parents who have been present at the 4 sessions / Number of parents included (having agreed to participate in the program) |
Week 5
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
reaching the target population
Délai: Week 5
|
number of parents to whom the program has been proposed / number of parents having had a child having consulted for suicidal ideation |
Week 5
|
|
Intermediate program effectiveness by comparison of levels of parents' responses between the start of program and the end of the last session of the program
Délai: Week 5
|
level of knowledge about suicidal behavior: degree of certainty a knowledge quiz built for the program |
Week 5
|
|
Intermediate program effectiveness by comparison of levels of parents' responses between the start of program and the end of the last session of the program
Délai: Week 5
|
parents' quality of life: score WHOQOL-BREF scale |
Week 5
|
|
adoption of the program by health professionals
Délai: Week 5
|
number of emergency professionals offering program for parents / number of emergency professionals treating children having consulted for suicidal ideation |
Week 5
|
|
Implementation on other dimensions
Délai: Week 5
|
Number of parents participating in at least a session |
Week 5
|
|
Implementation on other dimensions
Délai: Week 5
|
Satisfaction of participating parents: Parent Evaluation self-questionnaire Inventory-Parent Treatment |
Week 5
|
|
Implementation on other dimensions
Délai: Week 5
|
Describe the parents' experience participant in the PEPPS program: analysis qualitative (interview) |
Week 5
|
|
sustainability of the program (Maintenance): Interview
Délai: Week 9
|
Identify the brakes and levers implementation of the program, in order to identify avenues for improvement and dissemination of psychoeducation program: analysis qualitative |
Week 9
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- APHP231318
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .