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

University of Nimes

Status: Not yet enrolling

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

Treatments: Behavioral: Interact Module; Behavioral: Control Group; Behavioral: Adapt Module; Behavioral: Engage Module

Study type: Interventional

Funder types: Other

Identifiers

NCT06059092

PrevAdo

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 12 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 4 patient groups, including a placebo group

Adapt Module

Experimental group

Description:

Module targeting reactive adaptation processes

Treatment:

Behavioral: Adapt Module

Engage Module

Experimental group

Description:

Module targeting proactive adaptation processes

Treatment:

Behavioral: Engage Module

Interact Module

Experimental group

Description:

Module targeting interpersonal adaptation processes

Treatment:

Behavioral: Interact Module

Control group

Placebo Comparator group

Description:

Sessions targeting cognitive functions

Treatment:

Behavioral: Control Group