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

NCT06059092 | Unknown

• 1 other identifier: PrevAdo
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Anxiety; Depression; Psychosocial adjustment; Emotional wellbeing; Social wellbeing; Psychological wellbeing

Outcome Measures

Primary Outcomes (9)

• General distress

  Anxiety and depressive symptoms (Hospital Anxiety and Depression Scale). A high score on each subscale (anxiety symptoms subscale, 7 items, and depression symptoms subscale, 7 items), ranging from 0 to 21, indicates a high level of anxiety or depression. A high composite score (addition of scores yielded by the 2 subscales), ranging from 0 to 42, indicates a high level of general distress.

  Post-test 3 weeks after pre-test, follow-up 3 months after post-test

• Wellbeing

  Psychological, social and emotional well-being (Mental Health Continuum-Short Form). A high score on each emotional, social, and psychological wellbeing subscales, ranging from 3 or 6 to 18 or 36 depending on subscales, indicate a high level of each kind of wellbeing. A high composite score (ranging from 14 to 84) indicates a high level of general wellbeing.

  Post-test 3 weeks after pre-test, follow-up 3 months after post-test

• Functional impairment

  Functional impairment in school, social, personal, domestic areas (Work and Social Adjustment Scale for Youth; WSAS-Y). A high score (ranging from 0 to 40) indicates a high level of functional impairment across these life areas.

  Post-test 3 weeks after pre-test, follow-up 3 months after post-test

• Psychosocial difficulties

  Psychosocial difficulties of various internalized and externalized natures, measured by the Pediatric Symptom Checklist (PSC). A high score (ranging from 0 to 70) indicates a high level of psychosocial difficulties.

  Post-test 3 weeks after pre-test, follow-up 3 months after post-test

• Type of coping strategies

  Brief-COPE. A high score on each of the 14 strategies subscales (e.g., denial, acceptance, planning, disengagement), ranging from 2 to 8, indicates a frequent use of each strategy.

  Post-test 3 weeks after pre-test, follow-up 3 months after post-test

• Coping Flexibility

  Coping Flexibility Scale. A high score (ranging from 7 to 28) indicates a high level of coping flexibility.

  Post-test 3 weeks after pre-test, follow-up 3 months after post-test

• Tendency to engage in committed action

  Willingness and Action Measurement for Children and Adolescents (WAM-C/a), Action subscales. A high score (ranging from 9 to 45) indicate a high tendency do carry out actions related to important personal values despite negative feelings.

  Post-test 3 weeks after pre-test, follow-up 3 months after post-test

• General Self-Efficacy

  General Self Efficacy scale-Short-form (S-GSES). A high score (ranging from 3 to 15) indicates a high level of general self-efficacy.

  Post-test 3 weeks after pre-test, follow-up 3 months after post-test

• Assertiveness in interaction

  Ability to express feelings and opinions to others and to respect others (Assertiveness Formative Questionnaire)

  Post-test 3 weeks after pre-test, follow-up 3 months after post-test

Secondary Outcomes (7)

• User experience questionnaire

  Post-test 3 weeks after pre-test, follow-up 3 months after post-test

• Sociodemographic data 1

  Post-test 3 weeks after pre-test, follow-up 3 months after post-test

• Sociodemographic data 2

  Post-test 3 weeks after pre-test, follow-up 3 months after post-test

• Sociodemographic data 3

  Post-test 3 weeks after pre-test, follow-up 3 months after post-test

• Sociodemographic data 4

  Post-test 3 weeks after pre-test, follow-up 3 months after post-test

Study Arms (4)

Adapt Module

EXPERIMENTAL

Module targeting reactive adaptation processes

Behavioral: Adapt Module

Engage Module

EXPERIMENTAL

Module targeting proactive adaptation processes

Behavioral: Engage Module

Interact Module

EXPERIMENTAL

Module targeting interpersonal adaptation processes

Behavioral: Interact Module

Control group

PLACEBO COMPARATOR

Sessions targeting cognitive functions

Behavioral: Control Group

Interventions

Adapt Module 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.

Adapt Module

Engage Module 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.

Engage Module

Interact Module 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.

Interact Module

Control Group BEHAVIORAL

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

Control group

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• absence or withdrawal of consent (parent or student)
• missing more than 1 in 4 sessions

Sponsors & Collaborators

• University of Nimes: lead

Study Sites (2)

Institut Valsainte

Nîmes, Gard, 30 000, France

Location

Collège Révolution

Nîmes, Gard, 30000, France

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Elodie Charbonnier, MCF HDR

  UPR APSY-v University of Nîmes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugenie Vaillant-Coindard, PhD Student

CONTACT

06 52 63 89 31; eugenie.vaillant-coindard@unimes.fr

Elodie Charbonnier, MCF HDR

CONTACT

elodie.charbonnier@unimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Qualified to Direct Research, Internal Research Unit Director

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: September 28, 2023
• Study Start: November 6, 2023
• Primary Completion: December 22, 2023
• Study Completion: March 31, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

FR (2)