Mental Health Clinical Trial
Official title:
"EspaiJove.Net"- a School-based Intervention Program to Promote Mental Health and Eradicating Stigma in Adolescent Population: a Randomised Controlled Trial
Verified date | July 2019 |
Source | Centre d'Higiene Mental Les Corts |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 432 |
Est. completion date | March 22, 2019 |
Est. primary completion date | March 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 18 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Centre Higiene Mental Les Corts | Barcelona | |
Spain | Rocio Casañas | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Centre d'Higiene Mental Les Corts |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | Health Benefits Questionnaire | We developed a 17-items questionnaire to evaluate family, academic and general health benefits. | Baseline | |
Secondary | 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 | |
Secondary | 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. |
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