Evaluation of Three School-based Mental Health Preventive Interventions in France

NCT06059092 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-09-28

No results posted yet for this study

Summary

To meet adolescents' needs regarding mental health vulnerability, this study aims to propose and evaluate three original school-based preventive interventions delivered to French 13y-adolescents, with respect to their effects on mental health outcomes, as well as users' experiences of intervention, evaluated through questionnaires. Based on cognitive-behavioral therapies (CBT) techniques, these interventions target three strategic process areas: reactive adaptation, proactive adaptation, and interpersonal adaptation. Their effectiveness will be evaluated through a four-arm randomized controlled trial, conducted in an ecological context. Intra-group and inter-group comparisons will be carried out for our different variables of interest, namely targeted psychological processes, levels of distress, functional impairment, and well-being, and user experience indicators of acceptability, utility, and usability.

Conditions

  • Emotional Distress
  • Functional Impairment
  • Psychosocial Problem
  • Wellbeing
  • User Experience

Interventions

BEHAVIORAL

Adapt Module

In each intervention, participants will be trained selected psychological skills using cognitive-behavioral-inspired techniques related to coping strategies, locus of control, coping metacognition, positive psychology strategies. Activities will involve brainstorming and exercises based on fictional situations, allowing active participation and reflection as well as feedback from animators and peers. Activities and aids have been designed to meet adolescents' developmental level, concerns and capacities and to support effective learning. Participants will be asked to carry out home tasks to practice learned skills. They will also be provided additional resources related to their module's thematic, accessible through a workbook and a website.

BEHAVIORAL

Engage Module

In each intervention, participants will be trained selected psychological skills using cognitive-behavioral-inspired techniques related to goal setting, planning, strengths identification, motivation; goal pursuit metacognition. Activities will involve brainstorming and exercises based on fictional situations, allowing active participation and reflection as well as feedback from animators and peers. Activities and aids have been designed to meet adolescents' developmental level, concerns and capacities and to support effective learning. Participants will be asked to carry out home tasks to practice learned skills. They will also be provided additional resources related to their module's thematic, accessible through a workbook and a website.

BEHAVIORAL

Interact Module

In each intervention, participants will be trained selected psychological skills using cognitive-behavioral-inspired techniques related to social cognition, assertive communication and conflict resolution, proactive prosocial behaviors, interactional metacognition. Activities will involve brainstorming and exercises based on fictional situations, allowing active participation and reflection as well as feedback from animators and peers. Activities and aids have been designed to meet adolescents' developmental level, concerns and capacities and to support effective learning. Participants will be asked to carry out home tasks to practice learned skills. They will also be provided additional resources related to their module's thematic, accessible through a workbook and a website.

BEHAVIORAL

Control Group

Sessions will be devoted to serious game training cognitive and executive functions through individual and group activities based on board games.

Sponsors & Collaborators

  • University of Nimes

    lead OTHER

Principal Investigators

  • Elodie Charbonnier, MCF HDR · UPR APSY-v University of Nîmes

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2023-12-22
Completion
2024-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06059092 on ClinicalTrials.gov