Effects of Three Prophylactic Interventions on French Middle-schoolers' Mental Health: Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- General distress
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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).
入排标准
- 年龄范围
- 12 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •being enrolled in one of the middle school involved in the study
- •parent and student consent for participation
- •parent and student proficiency in French
排除标准
- •absence or withdrawal of consent (parent or student)
- •missing more than 1 in 4 sessions
结局指标
主要结局
General distress
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
elodie charbonnier
Lecturer, Qualified to Direct Research, Internal Research Unit Director
University of Nimes