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Clinical Trials/NCT03215654
NCT03215654CompletedNot Applicable

"EspaiJove.Net"- a School-based Intervention Program to Promote Mental Health and Eradicating Stigma in Adolescent Population: a Randomised Controlled Trial

Centre d'Higiene Mental Les Corts4 sites in 1 country432 target enrollmentStarted: October 2, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
432
Locations
4
Primary Endpoint
Change in the Mental Health knowledge

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
13 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Intervention: "EspaiJove.net" mental health literacy program (Other)

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.

Intervention: "EspaiJove.net" mental health literacy program (Other)

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.

Intervention: "EspaiJove.net" mental health literacy program (Other)

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

Outcomes

Primary Outcomes

Change in the Mental Health knowledge

Time Frame: 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).

Time Frame: 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 Outcomes

  • Change in the Use of Health Services and Treatment(Change from Baseline to 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.)
  • 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.)
  • Change in the Quality of life(Change from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.)
  • Health Benefits Questionnaire(Baseline)
  • Acceptability and satisfaction of the intervention(2 weeks after the intervention)
  • 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.)

Investigators

Sponsor
Centre d'Higiene Mental Les Corts
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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