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

Not Applicable

Completed

• Conditions: Stigma, Social; Mental Health

• Registration Number: NCT03215654
• Lead Sponsor: Centre d'Higiene Mental Les Corts

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-12
• Study Start: 2017-10-02
• Primary Completion: 2018-03-15
• Study Completion: 2019-03-22
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 432

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in the Mental Health knowledge	Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.	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 in the Scaling Community Attitudes toward the Mentally Ill (CAMI).	Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.	Behaviour and Attitudes towards Mental health ( stigma)

Secondary Outcome Measures

Name	Time	Method
Change in the Use of Health Services and Treatment	Change from Baseline to 6 months and 12 months after the intervention.	We developed a 8- ítems questionnaire to evaluate the use of health services and treatment
Change in the Intentions to Change	Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.	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 in the Help-seeking	Change from Baseline to 6 months and 12 months after the intervention.	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 in the Reported and Intended Behaviour Scale (RIBS)	Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.	Behaviour and Attitudes towards Mental health ( stigma)
Change in the Quality of life	Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.	We will use a Spanish validated version of the EuroQol 5D-5L questionnaire (EQ-5D-5L)
Health Benefits Questionnaire	Baseline	We developed a 17-items questionnaire to evaluate family, academic and general health benefits.
Acceptability and satisfaction of the intervention	2 weeks after 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.
Change in the Mental health symptoms and emotional well-being	Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.	The Strengths and Difficulties Scale (SDQ) will assess mental health symptoms and emotional well-being.
Change in the Bullying and Cyberbullying questionnaire	Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.	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.

Trial Locations

Locations (2)

Centre Higiene Mental Les Corts; 🇪🇸 Barcelona, Spain

Rocio Casañas; 🇪🇸 Barcelona, Spain