Effects of Three Prophylactic Interventions on French Middle-schoolers' Mental Health: Protocol for a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Emotional Distress
- Sponsor
- University of Nimes
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- General distress
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
elodie charbonnier
Lecturer, Qualified to Direct Research, Internal Research Unit Director
University of Nimes
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
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.
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.
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)
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.
Secondary Outcomes
- Sociodemographic data 1(Post-test 3 weeks after pre-test, follow-up 3 months after post-test)
- Sociodemographic data 5(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 4(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 6(Post-test 3 weeks after pre-test, follow-up 3 months after post-test)
- User experience questionnaire(Post-test 3 weeks after pre-test, follow-up 3 months after post-test)