NCT03215654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
432

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 2, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2019

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

July 4, 2017

Last Update Submit

July 24, 2019

Conditions

Mental HealthStigma, Social

Keywords

mental healthpromotionpreventionadolescenceschool programsintervention

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • 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.

  • Change in the Bullying and Cyberbullying questionnaire

    Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.

  • Change in the Quality of life

    Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.

  • Change in the Intentions to Change

    Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.

  • Change in the Help-seeking

    Change from Baseline to 6 months and 12 months after the intervention.

  • +4 more secondary outcomes

Study Arms (4)

Sensitization Program (SP)

EXPERIMENTAL

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

Mental Health Literacy Program (MHL)

EXPERIMENTAL

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

MHL more Stigma Reduction (ER)

EXPERIMENTAL

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

Control group

NO INTERVENTION

Control group will be a waiting list condition and they will receive the full program of 7h at the next year of academic course

Interventions

"EspaiJove.net" mental health literacy programOTHER

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.

MHL more Stigma Reduction (ER)Mental Health Literacy Program (MHL)Sensitization Program (SP)

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Attending any special education school;
  • Students with special educational needs who attend any school;
  • Not understanding Spanish and Catalan language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Higiene Mental Les Corts

Barcelona, 08029, Spain

Location

Rocio Casañas

Barcelona, 08029, Spain

Location

Related Publications (2)

  • Casanas R, Castellvi P, Gil JJ, Torres-Torres M, Baron J, Teixido M, Sampietro HM, Diez M, Fernandez R, Sorli R, Sinol P, Jurado F, Carreras-Salvador R, Vazquez D, Gonzalez S, Martin MIF, Raya-Tena A, Alvarez R, Amado-Rodriguez I, Lopez LMM, Alonso J, Lalucat-Jo L. The effectiveness of a "EspaiJove.net"- a school-based intervention programme in increasing mental health knowledge, help seeking and reducing stigma attitudes in the adolescent population: a cluster randomised controlled trial. BMC Public Health. 2022 Dec 24;22(1):2425. doi: 10.1186/s12889-022-14558-y.

    PMID: 36566192DERIVED

  • 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.

    PMID: 30064404DERIVED

Related Links

MeSH Terms

Conditions

Psychological Well-BeingSocial Stigma

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorSocial Behavior

Study Officials

  • Lluis Lalucat

    Centre Higiene Mental Les Corts

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2017

First Posted

July 12, 2017

Study Start

October 2, 2017

Primary Completion

March 15, 2018

Study Completion

March 22, 2019

Last Updated

July 25, 2019

Record last verified: 2019-07

Locations

ES(2)