EspaiJove.Net- a School-based Intervention Program to Promote Mental Health in Adolescent Population

Study Overview
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Brief Summary
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Objective: To evaluate the efficacy of 3 sensitivity and mental health literacy programs for young students in the increase of mental health knowledge, to help seeking and reducing the stigma in order to prevent mental disorders and to reduce symptoms. Design: Multicenter randomized clinical trial school-based during 12 months follow up. Setting: Educational centers of secondary education (E.S.O) (public or private) of Barcelona. Subjects: 408 students between 13 and 18 years old who attend 3rt ESO in 8 randomized schools of Barcelona. Interventions: 3 intervention groups of ascending intensity: 1) Sensitivity Program Mental Health (SP)(1h); 2) Mental Health Literacy Program (MHLP) (6h); 3) MHLP more Stigma Reduction (ER) ( MHLP+RE)(7h).Control group: waiting List. Measures of results:1) Mental Health Literacy; 2) Stigma associated with mental health; 3) Mental Symptoms and Positive Mental Health (SDQ); 4) Bullying and Ciberbullying; 5) Quality of life (E-5D); 6) Intent to change; 7) Help Seeking (AHSQ); 8) Use of Health Services and Treatment and 9) Satisfaction.

Official Title
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EspaiJove.Net- a School-based Intervention Program to Promote Mental Health and Eradicating Stigma in Adolescent Population: a Randomised Controlled Trial

Conditions
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Mental Health, Stigma, Social

Intervention / Treatment
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* Other: EspaiJove.net mental health literacy program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescents students who are currently attending the 3rd grade of E.S.O (corresponding to 9th grade in U.S.) in Barcelona, Spain; Sign the informed consent Exclusion Criteria: Attending any special education school; Students with special educational needs who attend any school; Not understanding Spanish and Catalan language.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sensitization Program (SP)<br>Include the concepts of mental health and mental disorder, healthy and risky behaviors of mental health, and use of health services. Duration 1 hour. | Other: EspaiJove.net mental health literacy program<br>* The EspaiJove.net: a space for mental health (EspaiJove.net) project is a MHL program which aims the promotion of mental health, the prevention of mental disorders, the facilitation of help-seeking behaviors and the eradication of stigma among secoundary students into the Spanish context.<br>|
| Experimental: Mental Health Literacy Program (MHL)<br>MHL module contents are: 1) Our emotions. Definitions of mental health and mental disorders. Mental health multidisciplinary team network; 2) Healthy and risky behaviors of mental health; 3) Social skills and antisocial behavior, bullying and cyberbullying; 4) Anxiety, depression, self-harm, and suicidal behaviors; 5) Eating and behavioral disorders; 6) Substance abuse (alcohol and cannabis), an psychotic disorder. Duration 6 hours. | Other: EspaiJove.net mental health literacy program<br>* The EspaiJove.net: a space for mental health (EspaiJove.net) project is a MHL program which aims the promotion of mental health, the prevention of mental disorders, the facilitation of help-seeking behaviors and the eradication of stigma among secoundary students into the Spanish context.<br>|
| Experimental: MHL more Stigma Reduction (ER)<br>Includes the six teaching units of MHL and a first contact presentation with lived experience of any mental disorder, who will be delivered by a voluntary member of Activament Catalunya Associació (http://www.activament.org/es), a non-profit group specialized in reducing stigma. Duration 7 hours. | Other: EspaiJove.net mental health literacy program<br>* The EspaiJove.net: a space for mental health (EspaiJove.net) project is a MHL program which aims the promotion of mental health, the prevention of mental disorders, the facilitation of help-seeking behaviors and the eradication of stigma among secoundary students into the Spanish context.<br>|
| No Intervention: Control group<br>Control group will be a waiting list condition and they will receive the full program of 7h at the next year of academic course | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Mental Health knowledge | This questionnaire is divided by two sections: (a) an identification list of mental disorders from a list of several diseases; (b) 20 questions with 4 possible answer choices which only one is correct. | Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention. | 
| Change in the Scaling Community Attitudes toward the Mentally Ill (CAMI). | Behaviour and Attitudes towards Mental health ( stigma) | Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Mental health symptoms and emotional well-being | The Strengths and Difficulties Scale (SDQ) will assess mental health symptoms and emotional well-being. | Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention. | 
| Change in the Bullying and Cyberbullying questionnaire | We developed four yes/no questions to ask whether he/she has been a victim or perpetrator of a bullying and/or a cyberbullying experience. | Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention. | 
| Change in the Quality of life | We will use a Spanish validated version of the EuroQol 5D-5L questionnaire (EQ-5D-5L) | Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention. | 
| Change in the Intentions to Change | We will use the adapted Spanish version of the States of Change Scale (SCS). This is based on the Transtheoretical Change Model developed by J. Prochaska and C. DiClemente to assess the degree intention, disposition or attitude towards change. | Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention. | 
| Change in the Help-seeking | We selected and adapted the first item from the Spanish version of the General Help-Seeking Questionnaire (GHSQ) for measuring help-seeking behaviour in adolescents. | Change from Baseline to 6 months and 12 months after the intervention. | 
| Change in the Use of Health Services and Treatment | We developed a 8- ítems questionnaire to evaluate the use of health services and treatment | Change from Baseline to 6 months and 12 months after the intervention. | 
| Health Benefits Questionnaire | We developed a 17-items questionnaire to evaluate family, academic and general health benefits. | Baseline | 
| Acceptability and satisfaction of the intervention | We developed a short questionnaire for assessing acceptability and satisfaction to measure the degree of receptivity of the people to the interventions proposed. | 2 weeks after the intervention | 
| Change in the Reported and Intended Behaviour Scale (RIBS) | Behaviour and Attitudes towards Mental health ( stigma) | Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mental health, promotion, prevention, adolescence, school programs, intervention