Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-27 @ 6:13 AM
Study NCT ID:
NCT06059092
Status:
UNKNOWN
Last Update Posted:
2023-09-28
First Post:
2023-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Three School-based Mental Health Preventive Interventions in France
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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).'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2023-09-17', 'studyFirstSubmitQcDate': '2023-09-22', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'General distress', 'timeFrame': 'Post-test 3 weeks after pre-test, follow-up 3 months after post-test', 'description': '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.'}, {'measure': 'Wellbeing', 'timeFrame': 'Post-test 3 weeks after pre-test, follow-up 3 months after post-test', 'description': '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.'}, {'measure': 'Functional impairment', 'timeFrame': 'Post-test 3 weeks after pre-test, follow-up 3 months after post-test', 'description': '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.'}, {'measure': 'Psychosocial difficulties', 'timeFrame': 'Post-test 3 weeks after pre-test, follow-up 3 months after post-test', 'description': '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.'}, {'measure': 'Type of coping strategies', 'timeFrame': 'Post-test 3 weeks after pre-test, follow-up 3 months after post-test', 'description': '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.'}, {'measure': 'Coping Flexibility', 'timeFrame': 'Post-test 3 weeks after pre-test, follow-up 3 months after post-test', 'description': 'Coping Flexibility Scale. A high score (ranging from 7 to 28) indicates a high level of coping flexibility.'}, {'measure': 'Tendency to engage in committed action', 'timeFrame': 'Post-test 3 weeks after pre-test, follow-up 3 months after post-test', 'description': '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.'}, {'measure': 'General Self-Efficacy', 'timeFrame': 'Post-test 3 weeks after pre-test, follow-up 3 months after post-test', 'description': 'General Self Efficacy scale-Short-form (S-GSES). A high score (ranging from 3 to 15) indicates a high level of general self-efficacy.'}, {'measure': 'Assertiveness in interaction', 'timeFrame': 'Post-test 3 weeks after pre-test, follow-up 3 months after post-test', 'description': 'Ability to express feelings and opinions to others and to respect others (Assertiveness Formative Questionnaire)'}], 'secondaryOutcomes': [{'measure': 'User experience questionnaire', 'timeFrame': 'Post-test 3 weeks after pre-test, follow-up 3 months after post-test', 'description': "Participants' perceived utility, acceptability, usability and general appreciation of the interventions"}, {'measure': 'Sociodemographic data 1', 'timeFrame': 'Post-test 3 weeks after pre-test, follow-up 3 months after post-test', 'description': "Adolescents' gender (qualitative questionnaire, unscored)"}, {'measure': 'Sociodemographic data 2', 'timeFrame': 'Post-test 3 weeks after pre-test, follow-up 3 months after post-test', 'description': "Adolescents' age (questionnaire, unscored)"}, {'measure': 'Sociodemographic data 3', 'timeFrame': 'Post-test 3 weeks after pre-test, follow-up 3 months after post-test', 'description': "Adolescents' current and previous diagnoses and treatments qualitative (qualitative questionnaire, unscored)"}, {'measure': 'Sociodemographic data 4', 'timeFrame': 'Post-test 3 weeks after pre-test, follow-up 3 months after post-test', 'description': 'Family status (qualitative questionnaire, unscored)'}, {'measure': 'Sociodemographic data 5', 'timeFrame': 'Post-test 3 weeks after pre-test, follow-up 3 months after post-test', 'description': 'Home income (questionnaire, unscored)'}, {'measure': 'Sociodemographic data 6', 'timeFrame': 'Post-test 3 weeks after pre-test, follow-up 3 months after post-test', 'description': "Parents' gender, profession, education level (qualitative questionnaire, unscored)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety', 'Depression', 'Psychosocial adjustment', 'Emotional wellbeing', 'Social wellbeing', 'Psychological wellbeing'], 'conditions': ['Emotional Distress', 'Functional Impairment', 'Psychosocial Problem', 'Wellbeing', 'User Experience']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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).\n\nFor 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).\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being enrolled in one of the middle school involved in the study\n* parent and student consent for participation\n* parent and student proficiency in French\n\nExclusion Criteria:\n\n* absence or withdrawal of consent (parent or student)\n* missing more than 1 in 4 sessions'}, 'identificationModule': {'nctId': 'NCT06059092', 'briefTitle': 'Evaluation of Three School-based Mental Health Preventive Interventions in France', 'organization': {'class': 'OTHER', 'fullName': 'University of Nimes'}, 'officialTitle': "Effects of Three Prophylactic Interventions on French Middle-schoolers' Mental Health: Protocol for a Randomized Controlled Trial", 'orgStudyIdInfo': {'id': 'PrevAdo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adapt Module', 'description': 'Module targeting reactive adaptation processes', 'interventionNames': ['Behavioral: Adapt Module']}, {'type': 'EXPERIMENTAL', 'label': 'Engage Module', 'description': 'Module targeting proactive adaptation processes', 'interventionNames': ['Behavioral: Engage Module']}, {'type': 'EXPERIMENTAL', 'label': 'Interact Module', 'description': 'Module targeting interpersonal adaptation processes', 'interventionNames': ['Behavioral: Interact Module']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Sessions targeting cognitive functions', 'interventionNames': ['Behavioral: Control Group']}], 'interventions': [{'name': 'Adapt Module', 'type': 'BEHAVIORAL', 'description': "In each intervention, participants will be trained selected psychological skills using cognitive-behavioral-inspired techniques related to coping strategies, locus of control, coping metacognition, positive psychology strategies. Activities will involve brainstorming and exercises based on fictional situations, allowing active participation and reflection as well as feedback from animators and peers. Activities and aids have been designed to meet adolescents' developmental level, concerns and capacities and to support effective learning. Participants will be asked to carry out home tasks to practice learned skills. They will also be provided additional resources related to their module's thematic, accessible through a workbook and a website.", 'armGroupLabels': ['Adapt Module']}, {'name': 'Engage Module', 'type': 'BEHAVIORAL', 'description': "In each intervention, participants will be trained selected psychological skills using cognitive-behavioral-inspired techniques related to goal setting, planning, strengths identification, motivation; goal pursuit metacognition. Activities will involve brainstorming and exercises based on fictional situations, allowing active participation and reflection as well as feedback from animators and peers. Activities and aids have been designed to meet adolescents' developmental level, concerns and capacities and to support effective learning. Participants will be asked to carry out home tasks to practice learned skills. They will also be provided additional resources related to their module's thematic, accessible through a workbook and a website.", 'armGroupLabels': ['Engage Module']}, {'name': 'Interact Module', 'type': 'BEHAVIORAL', 'description': "In each intervention, participants will be trained selected psychological skills using cognitive-behavioral-inspired techniques related to social cognition, assertive communication and conflict resolution, proactive prosocial behaviors, interactional metacognition. Activities will involve brainstorming and exercises based on fictional situations, allowing active participation and reflection as well as feedback from animators and peers. Activities and aids have been designed to meet adolescents' developmental level, concerns and capacities and to support effective learning. Participants will be asked to carry out home tasks to practice learned skills. They will also be provided additional resources related to their module's thematic, accessible through a workbook and a website.", 'armGroupLabels': ['Interact Module']}, {'name': 'Control Group', 'type': 'BEHAVIORAL', 'description': 'Sessions will be devoted to serious game training cognitive and executive functions through individual and group activities based on board games.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30 000', 'city': 'Nîmes', 'state': 'Gard', 'country': 'France', 'contacts': [{'name': 'Claudine Averseng, Director', 'role': 'CONTACT', 'email': 'direction@institut-valsainte.fr'}], 'facility': 'Institut Valsainte', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '30000', 'city': 'Nîmes', 'state': 'Gard', 'country': 'France', 'contacts': [{'name': 'Mathias Garçon, Principal', 'role': 'CONTACT', 'email': 'ce.0300946r@ac-montpellier.fr', 'phone': '04 66 67 49 36'}], 'facility': 'Collège Révolution', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'centralContacts': [{'name': 'Eugenie Vaillant-Coindard, PhD Student', 'role': 'CONTACT', 'email': 'eugenie.vaillant-coindard@unimes.fr', 'phone': '06 52 63 89 31'}, {'name': 'Elodie Charbonnier, MCF HDR', 'role': 'CONTACT', 'email': 'elodie.charbonnier@unimes.fr'}], 'overallOfficials': [{'name': 'Elodie Charbonnier, MCF HDR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UPR APSY-v University of Nîmes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nimes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer, Qualified to Direct Research, Internal Research Unit Director', 'investigatorFullName': 'elodie charbonnier', 'investigatorAffiliation': 'University of Nimes'}}}}