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

Emotional Distress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06059092
• Other study ID #: PrevAdo
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 6, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: September 2023
• Source: University of Nimes
• Contact: Eugenie Vaillant-Coindard, PhD Student
• Phone: 06 52 63 89 31
• Email: eugenie.vaillant-coindard[@]unimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 31, 2024
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Collège Révolution	Nîmes	Gard
France	Institut Valsainte	Nîmes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
University of Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	User experience questionnaire	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
Secondary	Sociodemographic data 1	Adolescents' gender (qualitative questionnaire, unscored)	Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Secondary	Sociodemographic data 2	Adolescents' age (questionnaire, unscored)	Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Secondary	Sociodemographic data 3	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
Secondary	Sociodemographic data 4	Family status (qualitative questionnaire, unscored)	Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Secondary	Sociodemographic data 5	Home income (questionnaire, unscored)	Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Secondary	Sociodemographic data 6	Parents' gender, profession, education level (qualitative questionnaire, unscored)	Post-test 3 weeks after pre-test, follow-up 3 months after post-test