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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 : Active, not recruiting
First Posted : July 12, 2017
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Centre d'Higiene Mental Les Corts

July 4, 2017
July 12, 2017
June 6, 2018
October 2, 2017
March 15, 2018   (Final data collection date for primary outcome measure)
  • 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)
  • 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 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)
  • 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)
Complete list of historical versions of study NCT03215654 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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)
  • 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.
  • 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.
  • 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
  • Health Benefits Questionnaire [ Time Frame: Baseline ]
    We developed a 17-items questionnaire to evaluate family, academic and general health benefits.
  • 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.
  • 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)
  • 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.
  • 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.
  • 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)
  • 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.
  • 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.
  • 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
  • Health Benefits Questionnaire [ Time Frame: Baseline ]
    We developed a 17-items questionnaire to evaluate family, academic and general health benefits.
  • 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.
Not Provided
Not Provided
 
"EspaiJove.Net"- a School-based Intervention Program to Promote Mental Health in Adolescent Population
"EspaiJove.Net"- a School-based Intervention Program to Promote Mental Health and Eradicating Stigma in Adolescent Population: a Randomised Controlled Trial

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Mental Health
  • Stigma, Social
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: 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.
    Intervention: Other: "EspaiJove.net" mental health literacy program
  • 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.
    Intervention: Other: "EspaiJove.net" mental health literacy program
  • 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.
    Intervention: Other: "EspaiJove.net" mental health literacy program
  • 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
Casañas R, Arfuch VM, Castellví P, Gil JJ, Torres M, Pujol A, Castells G, Teixidó 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
432
408
March 12, 2019
March 15, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
13 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT03215654
PI15/01613
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Centre d'Higiene Mental Les Corts
Centre d'Higiene Mental Les Corts
Not Provided
Principal Investigator: Lluis Lalucat Centre Higiene Mental Les Corts
Centre d'Higiene Mental Les Corts
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP