Clinical trial NCT06059092: Evaluation of Three School-based Mental Health Preventive Interventions in France
Official title: Effects of Three Prophylactic Interventions on French Middle-schoolers' Mental Health: Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emotional Distress
Functional Impairment
Psychosocial Problem
Wellbeing
User Experience
Keywords: Anxiety
Depression
Psychosocial adjustment
Emotional wellbeing
Social wellbeing
Psychological wellbeing
Lead sponsor: University of Nimes
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pre-test assessment will precede all interventions (experimental conditions) and control group sessions delivered simultaneously, and followed by a post-test assessment and and follow-up assessment three months after that.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: General distress
timeFrame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
measure: Wellbeing
timeFrame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
measure: Functional impairment
timeFrame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
measure: Psychosocial difficulties
timeFrame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
measure: Type of coping strategies
timeFrame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
measure: Coping Flexibility
timeFrame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
measure: Tendency to engage in committed action
timeFrame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
measure: General Self-Efficacy
timeFrame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
measure: Assertiveness in interaction
timeFrame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Secondary outcomes:
measure: User experience questionnaire
timeFrame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
measure: Sociodemographic data 1
timeFrame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
measure: Sociodemographic data 2
timeFrame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
measure: Sociodemographic data 3
timeFrame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
measure: Sociodemographic data 4
timeFrame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
measure: Sociodemographic data 5
timeFrame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
measure: Sociodemographic data 6
timeFrame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Institut Valsainte
state: Gard
city: Nîmes
country: France
facility: Collège Révolution
state: Gard
Study officials:
affiliation: UPR APSY-v University of Nîmes
name: Elodie Charbonnier, MCF HDR
role: PRINCIPAL_INVESTIGATOR
References: