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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2024-03-31

Brief Summary

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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.

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Detailed Description

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The three interventions will be delivered in school facilities, during school time, with 4th-grade middle school students, by one psychologist trained in CBT and one undergraduate student in clinical psychology in CBT. They involve participating in three one-hour weekly sessions, plus one booster sessions one month later. These three programs have been designed based on pre-existing knowledge about adolescents and their cognitive-motivational mechanisms, in order to promote their learning and receptiveness to interventions, and include group and individual activities meant to improve key psychological processes. The control group will consist of the same number of sessions of identical length as experimental conditions, dedicated to serious games meant to work on cognitive functions (attention, memory, logical reasoning).

For all participants, several indicators of mental health and of cognitive-behavioral processes will be measured through validated self- and parent-reported questionnaires, and completed by user experience questionnaires. Mixt linear models or non-parametric equivalent tests will be conducted to test hypotheses (i.e., positive change in all outcomes following interventions in the experimental conditions, not observed in the participants of the control group).

The interventions are preventive and will not target adolescents at risk for psychopathological conditions. Nevertheless, it is possible that at-risk individuals are enrolled in the sample. To meet special needs of some participants, from the beginning of the study, professional mental health resources (phone number, websites, institutions) will be provided to all participants. A clinical psychologist (one of tthe animator) will be available for students who would ask for individual appointments by handling duty periods in school facilities two hours a week during the interventions.

Conditions

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Emotional Distress Functional Impairment Psychosocial Problem Wellbeing User Experience

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A pre-test assessment will precede all interventions (experimental conditions) and control group sessions delivered simultaneously, and followed by a post-test assessment and and follow-up assessment three months after that.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Participants and their parents will not be aware of precise hypotheses. Nevertheless, for ethical reasons, they are informed that the interventions are meant to improve well-being (before random allocation to control or experimental conditions).

Study Groups

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Adapt Module

Module targeting reactive adaptation processes

Group Type EXPERIMENTAL

Adapt Module

Intervention Type BEHAVIORAL

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.

Engage Module

Module targeting proactive adaptation processes

Group Type EXPERIMENTAL

Engage Module

Intervention Type BEHAVIORAL

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.

Interact Module

Module targeting interpersonal adaptation processes

Group Type EXPERIMENTAL

Interact Module

Intervention Type BEHAVIORAL

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.

Control group

Sessions targeting cognitive functions

Group Type PLACEBO_COMPARATOR

Control Group

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Control Group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* being enrolled in one of the middle school involved in the study
* parent and student consent for participation
* parent and student proficiency in French