Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06059092
Study type Interventional
Source University of Nimes
Contact Eugenie Vaillant-Coindard, PhD Student
Phone 06 52 63 89 31
Email eugenie.vaillant-coindard@unimes.fr
Status Not yet recruiting
Phase N/A
Start date November 6, 2023
Completion date March 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Active, not recruiting NCT06035003 - Mechanism of Mindfulness-Based Online Intervention in Enhancing Cognitive Flexibility N/A
Not yet recruiting NCT06034613 - The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress: Daily Interventions and Daily Assessments N/A
Enrolling by invitation NCT05113706 - Does Bystanders Emotional State Influence Dispatcher-assisted Cardiopulmonary?Resuscitation
Not yet recruiting NCT06056232 - Mechanisms of Mindfulness Intervention: Distress Tolerance Dose Manipulation N/A
Active, not recruiting NCT05600790 - Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress N/A
Not yet recruiting NCT06103149 - The Role of Cognitive Flexibility in Mindfulness Intervention: a Functional Near-infrared Spectroscopy Study N/A
Completed NCT06436521 - The Efficacy of Online Brief Positive Cognitive Behavior Therapy Compared to Traditional Cognitive Behavior Therapy N/A
Not yet recruiting NCT06051929 - Mechanism of Mindfulness Intervention for Emotional Distress: the Role of Cognitive Flexibility N/A
Not yet recruiting NCT06087484 - The Effect of Mindfulness Intervention for Emotional Distress of Insomnia People N/A
Completed NCT05027113 - App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress N/A
Enrolling by invitation NCT04635618 - Psychotherapy Strategies for the Treatment of Professionals and Students From Essential Services With High Levels of Emotional Distress in the Context of COVID-19 N/A
Enrolling by invitation NCT04632082 - Telepsychoeducation for the Prevention of Emotional Distress in Professionals and Students From Essential Services in the Context of COVID-19 N/A
Completed NCT05510635 - The Effectiveness of Bibliotherapy on Emotional Distress, Coping Strategies and Resilience of Adolescents With Cancer N/A
Recruiting NCT05639465 - Intervention to Prevent Behavioral Health Symptoms Among Pandemic Affected Children N/A
Completed NCT04958941 - CUIDA-TE, an APP for the Emotional Management N/A
Not yet recruiting NCT06226467 - Neurobehavioral Affective Control Training N/A
Recruiting NCT05548699 - Precision Mental Health in Diabetes - Subtypes of Mental Health, Trajectories, and Patterns With Glycaemic Control
Completed NCT04816708 - A Self-directed Mobile Mindfulness Intervention to Address Distress and Burnout in Frontline Healthcare Workers N/A
Recruiting NCT05712057 - Neurostimulation Versus Therapy for Problems With Emotions N/A