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

Not Applicable

Not yet recruiting

• Conditions: Emotional Distress; Functional Impairment; User Experience; Psychosocial Problem; Wellbeing

• Registration Number: NCT06059092
• Lead Sponsor: University of Nimes

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.

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 Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-17
• Study First Submitted QC: 2023-09-22
• Last Update Submitted: 2023-09-22
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28
• Study Start: 2023-11-06
• Primary Completion: 2023-12-22
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
General distress	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.
Type of coping strategies	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.
Tendency to engage in committed action	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.
Wellbeing	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.
Functional impairment	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.
Psychosocial difficulties	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.
General Self-Efficacy	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.
Assertiveness in interaction	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)
Coping Flexibility	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.

Secondary Outcome Measures

Name	Time	Method
Sociodemographic data 1	Post-test 3 weeks after pre-test, follow-up 3 months after post-test	Adolescents' gender (qualitative questionnaire, unscored)
Sociodemographic data 5	Post-test 3 weeks after pre-test, follow-up 3 months after post-test	Home income (questionnaire, unscored)
Sociodemographic data 2	Post-test 3 weeks after pre-test, follow-up 3 months after post-test	Adolescents' age (questionnaire, unscored)
Sociodemographic data 4	Post-test 3 weeks after pre-test, follow-up 3 months after post-test	Family status (qualitative questionnaire, unscored)
Sociodemographic data 3	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)
Sociodemographic data 6	Post-test 3 weeks after pre-test, follow-up 3 months after post-test	Parents' gender, profession, education level (qualitative questionnaire, unscored)
User experience questionnaire	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

Trial Locations

Locations (2)

Institut Valsainte; 🇫🇷 Nîmes, Gard, France

Collège Révolution; 🇫🇷 Nîmes, Gard, France