Emotional DistressNCT06059092
Evaluation of Three School-based Mental Health Preventive Interventions in France
A study testing Adapt Module, Engage Module and Interact Module in people with Emotional Distress and Functional Impairment, run by University of Nimes at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Distress, Functional Impairment, Psychosocial Problem
- What is being tested?
- Adapt Module, Engage Module and Interact Module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Nov 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- being enrolled in one of the middle school involved in the study
- parent and student consent for participation
- parent and student proficiency in French
Who cannot join
- absence or withdrawal of consent (parent or student)
- missing more than 1 in 4 sessions
Trial locations and contacts
2 sites in 1 country.
Elodie Charbonnier, MCF HDR contact
France2 sites
Institut Valsainte
Nîmes, Gard, 30 000
Claudine Averseng, Director, direction@institut-valsainte.fr
Collège Révolution
Nîmes, Gard, 30000
Mathias Garçon, Principal, 04 66 67 49 36, ce.0300946r@ac-montpellier.fr
About this study
Official title: Effects of Three Prophylactic Interventions on French Middle-schoolers' Mental Health: Protocol for a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Emotional Distress, Functional Impairment, Psychosocial Problem, Wellbeing, User Experience
- Being tested
- Adapt Module, Engage Module, Interact Module, Control Group
- Keywords
- Anxiety, Depression, Psychosocial adjustment, Emotional wellbeing, Social wellbeing, Psychological wellbeing
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapt ModuleBehavioural
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.
Engage ModuleBehavioural
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.
Interact ModuleBehavioural
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.
Control GroupBehavioural
Sessions will be devoted to serious game training cognitive and executive functions through individual and group activities based on board games.
| Study group | Role | What they receive |
|---|---|---|
| Adapt Module | Experimental | Module targeting reactive adaptation processes Receives: Behavioral: Adapt Module |
| Engage Module | Experimental | Module targeting proactive adaptation processes Receives: Behavioral: Engage Module |
| Interact Module | Experimental | Module targeting interpersonal adaptation processes Receives: Behavioral: Interact Module |
| Control group | Placebo comparator | Sessions targeting cognitive functions Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
General distress
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.
Measured: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Wellbeing
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.
Measured: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Functional impairment
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.
Measured: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Psychosocial difficulties
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.
Measured: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Type of coping strategies
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.
Measured: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Coping Flexibility
Coping Flexibility Scale. A high score (ranging from 7 to 28) indicates a high level of coping flexibility.
Measured: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Tendency to engage in committed action
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.
Measured: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
General Self-Efficacy
General Self Efficacy scale-Short-form (S-GSES). A high score (ranging from 3 to 15) indicates a high level of general self-efficacy.
Measured: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Assertiveness in interaction
Ability to express feelings and opinions to others and to respect others (Assertiveness Formative Questionnaire)
Measured: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Secondary outcomes (7)
User experience questionnaire
Participants' perceived utility, acceptability, usability and general appreciation of the interventions
Measured: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Sociodemographic data 1
Adolescents' gender (qualitative questionnaire, unscored)
Measured: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Sociodemographic data 2
Adolescents' age (questionnaire, unscored)
Measured: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Sociodemographic data 3
Adolescents' current and previous diagnoses and treatments qualitative (qualitative questionnaire, unscored)
Measured: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Sociodemographic data 4
Family status (qualitative questionnaire, unscored)
Measured: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Sociodemographic data 5
Home income (questionnaire, unscored)
Measured: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Sociodemographic data 6
Parents' gender, profession, education level (qualitative questionnaire, unscored)
Measured: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start6 Nov 2023 (estimated)
- Primary completion22 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nimes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, elodie charbonnier, University of Nimes
- Investigators
- Elodie Charbonnier, MCF HDR, Principal investigator, UPR APSY-v University of Nîmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059092
- Sponsor's protocol ID
- PrevAdo
- Status last verified
- Sep 2023
- First submitted
- 17 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Three Prophylactic Interventions on French Middle-schoolers' Mental Health: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06059092
- Acronym / sponsor ID
- PrevAdo
- Conditions
- Emotional Distress, Functional Impairment, Psychosocial Problem, Wellbeing, User Experience
- Keywords
- Anxiety, Depression, Psychosocial adjustment, Emotional wellbeing, Social wellbeing, Psychological wellbeing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of NimesUniversity, hospital or other
- Study start
- 6 Nov 2023 (estimated)
- Primary completion
- 22 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Adapt Module | Experimental | Behavioral: Adapt ModuleModule targeting reactive adaptation processes |
| Engage Module | Experimental | Behavioral: Engage ModuleModule targeting proactive adaptation processes |
| Interact Module | Experimental | Behavioral: Interact ModuleModule targeting interpersonal adaptation processes |
| Control group | Placebo comparator | Behavioral: Control GroupSessions targeting cognitive functions |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- being enrolled in one of the middle school involved in the study
- parent and student consent for participation
- parent and student proficiency in French
Key exclusion criteria (2 listed)
- absence or withdrawal of consent (parent or student)
- missing more than 1 in 4 sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapt ModuleIn 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. | Behavioural | Adapt Module |
| Engage ModuleIn 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. | Behavioural | Engage Module |
| Interact ModuleIn 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. | Behavioural | Interact Module |
| Control GroupSessions will be devoted to serious game training cognitive and executive functions through individual and group activities based on board games. | Behavioural | Control group |
Primary outcome
General distress
Time frame: 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.
Wellbeing
Time frame: 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
Time frame: 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
Time frame: 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.
Type of coping strategies
Time frame: 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.
Coping Flexibility
Time frame: 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.
Tendency to engage in committed action
Time frame: 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.
General Self-Efficacy
Time frame: 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
Time frame: 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)
7 secondary outcomes
User experience questionnaire
Time frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Sociodemographic data 1
Time frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Sociodemographic data 2
Time frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Sociodemographic data 3
Time frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Sociodemographic data 4
Time frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Sociodemographic data 5
Time frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Sociodemographic data 6
Time frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elodie Charbonnier, MCF HDR contact
Elodie Charbonnier, MCF HDR principal investigator
UPR APSY-v University of Nîmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapt Module, Engage Module and Interact Module in people with Emotional Distress and Functional Impairment, run by University of Nimes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eugenie Vaillant-Coindard, PhD Student (06 52 63 89 31, eugenie.vaillant-coindard@unimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General distress (time frame: Post-test 3 weeks after pre-test, follow-up 3 months after post-test). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.