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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03215654
• Other study ID #: PI15/01613
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: March 22, 2019

Study information

• Verified date: July 2019
• Source: Centre d'Higiene Mental Les Corts
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Mental Health
• Stigma, Social

Intervention

Other:
• "EspaiJove.net" mental health literacy program
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.

Locations

Country	Name	City	State
Spain	Centre Higiene Mental Les Corts	Barcelona
Spain	Rocio Casañas	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Higiene Mental Les Corts

Country where clinical trial is conducted

Spain, 

Outcome

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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