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

September 22, 2023 updated by: elodie charbonnier, University of Nimes

Effects of Three Prophylactic Interventions on French Middle-schoolers' Mental Health: Protocol for a Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adapt Module
Module targeting reactive adaptation processes
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.
Experimental: Engage Module
Module targeting proactive adaptation processes
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.
Experimental: Interact Module
Module targeting interpersonal adaptation processes
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.
Placebo Comparator: Control group
Sessions targeting cognitive functions
Behavioral: Control Group
Sessions will be devoted to serious game training cognitive and executive functions through individual and group activities based on board games.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General distress
Time Frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
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
Time Frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
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
Time Frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
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
Time Frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
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
Time Frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
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
Time Frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
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
Time Frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
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
Time Frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
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
Time Frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
User experience questionnaire
Time Frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Participants' perceived utility, acceptability, usability and general appreciation of the interventions
Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Sociodemographic data 1
Time Frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Adolescents' gender (qualitative questionnaire, unscored)
Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Sociodemographic data 2
Time Frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Adolescents' age (questionnaire, unscored)
Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Sociodemographic data 3
Time Frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Adolescents' current and previous diagnoses and treatments qualitative (qualitative questionnaire, unscored)
Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Sociodemographic data 4
Time Frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Family status (qualitative questionnaire, unscored)
Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Sociodemographic data 5
Time Frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Home income (questionnaire, unscored)
Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Sociodemographic data 6
Time Frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Parents' gender, profession, education level (qualitative questionnaire, unscored)
Post-test 3 weeks after pre-test, follow-up 3 months after post-test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nimes

Investigators

  • Principal Investigator: Elodie Charbonnier, MCF HDR, UPR APSY-v University of Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 6, 2023

Primary Completion (Estimated)

December 22, 2023

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

September 17, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PrevAdo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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