Clinical trial NCT03215654: "EspaiJove.Net"- a School-based Intervention Program to Promote Mental Health in Adolescent Population
Official title: "EspaiJove.Net"- a School-based Intervention Program to Promote Mental Health and Eradicating Stigma in Adolescent Population: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Stigma, Social
Keywords: mental health
promotion
prevention
adolescence
school programs
intervention
Lead sponsor: Centre d'Higiene Mental Les Corts
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 432
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in the Mental Health knowledge
timeFrame: Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.
measure: Change in the Scaling Community Attitudes toward the Mentally Ill (CAMI).
timeFrame: Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.
Secondary outcomes:
measure: Change in the Mental health symptoms and emotional well-being
timeFrame: Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.
measure: Change in the Bullying and Cyberbullying questionnaire
timeFrame: Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.
measure: Change in the Quality of life
timeFrame: Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.
measure: Change in the Intentions to Change
timeFrame: Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.
measure: Change in the Help-seeking
timeFrame: Change from Baseline to 6 months and 12 months after the intervention.
measure: Change in the Use of Health Services and Treatment
timeFrame: Change from Baseline to 6 months and 12 months after the intervention.
measure: Health Benefits Questionnaire
timeFrame: Baseline
measure: Acceptability and satisfaction of the intervention
timeFrame: 2 weeks after the intervention
measure: Change in the Reported and Intended Behaviour Scale (RIBS)
timeFrame: Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centre Higiene Mental Les Corts
city: Barcelona
country: Spain
facility: Rocio Casañas
Study officials:
affiliation: Centre Higiene Mental Les Corts
name: Lluis Lalucat
role: PRINCIPAL_INVESTIGATOR
References:
citation: Casanas R, Arfuch VM, Castellvi P, Gil JJ, Torres M, Pujol A, Castells G, Teixido M, San-Emeterio MT, Sampietro HM, Caussa A, Alonso J, Lalucat-Jo L. "EspaiJove.net"- a school-based intervention programme to promote mental health and eradicate stigma in the adolescent population: study protocol for a cluster randomised controlled trial. BMC Public Health. 2018 Jul 31;18(1):939. doi: 10.1186/s12889-018-5855-1.