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

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ClinicalTrials.gov Identifier: NCT03215654
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Mental Health Stigma, Social Other: "EspaiJove.net" mental health literacy program Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: "EspaiJove.Net"- a School-based Intervention Program to Promote Mental Health and Eradicating Stigma in Adolescent Population: a Randomised Controlled Trial
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sensitization Program (SP)
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
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.
Experimental: Mental Health Literacy Program (MHL)
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
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.
Experimental: MHL more Stigma Reduction (ER)
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
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.
No Intervention: Control group
Control group will be a waiting list condition and they will receive the full program of 7h at the next year of academic course



Primary Outcome Measures :
  1. 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.

  2. Change in the Reported and Intended Behaviour Scale (RIBS) [ 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)

  3. 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 Outcome Measures :
  1. Change in the Mental health symptoms and emotional well-being [ Time Frame: 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.

  2. Change in the Bullying and Cyberbullying questionnaire [ Time Frame: 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.

  3. Change in the Quality of life [ Time Frame: 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)

  4. Change in the Intentions to Change [ Time Frame: 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.

  5. Change in the Help-seeking [ Time Frame: 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.

  6. Change in the Use of Health Services and Treatment [ Time Frame: 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

  7. Health Benefits Questionnaire [ Time Frame: Baseline ]
    We developed a 17-items questionnaire to evaluate family, academic and general health benefits.

  8. Acceptability and satisfaction of the intervention [ Time Frame: 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.



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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215654


Contacts
Contact: Rocio Casañas, PhD 0034 934198611 rocio.casanas@chmcorts.com

Locations
Spain
Centre Higiene Mental Les Corts Recruiting
Barcelona, Spain, 08029
Contact: Rocio Casañas, PhD    0034 934198611    rocio.casanas@chmcorts.com   
Principal Investigator: Lluis Lalucat         
Rocio Casañas Recruiting
Barcelona, Spain, 08029
Contact: Rocio Casañas, PhD    0034 934198611    rocio.casanas@chmcorts.com   
Principal Investigator: LLuis Lalucat         
Sub-Investigator: Rocio Casañas, PhD         
Sub-Investigator: Pere Castellvi, PhD         
Sub-Investigator: Aleix Caussa         
Sub-Investigator: Mercè Teixidó         
Sub-Investigator: Maite San Emeterio         
Sub-Investigator: Gemma Castells         
Sub-Investigator: Angels Pujol         
Sub-Investigator: Juan José Gil         
Sub-Investigator: Victoria M Arfuch         
Sponsors and Collaborators
Centre d'Higiene Mental Les Corts
Investigators
Principal Investigator: Lluis Lalucat Centre Higiene Mental Les Corts

Additional Information:
Responsible Party: Centre d'Higiene Mental Les Corts
ClinicalTrials.gov Identifier: NCT03215654     History of Changes
Other Study ID Numbers: PI15/01613
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre d'Higiene Mental Les Corts:
mental health
promotion
prevention
adolescence
school programs
intervention