- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03215654
"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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08029
- Centre Higiene Mental Les Corts
-
Barcelona, Spain, 08029
- Rocio Casañas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 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).
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 from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.
|
|
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 from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.
|
|
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 from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.
|
|
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 from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.
|
|
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 from Baseline to 6 months and 12 months after the intervention.
|
|
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
|
Change from Baseline to 6 months and 12 months after the intervention.
|
|
Health Benefits Questionnaire
Time Frame: Baseline
|
We developed a 17-items questionnaire to evaluate family, academic and general health benefits.
|
Baseline
|
|
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.
|
2 weeks after the intervention
|
|
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 from Baseline to 2 weeks after the intervention, 6 months and 12 months after the intervention.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lluis Lalucat, Centre Higiene Mental Les Corts
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PI15/01613
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mental Health
-
Sanctuary Mental Health MinistriesExcellence in Giving InsightsNot yet recruitingMental Health | Mental Health Help-Seeking | Mental Health LiteracyUnited States
-
Neslihan LokCompletedAdolescent | Mental Health | Mental Health Care | Mental Health ConditionsTurkey
-
GCS-CCOMSINSERM ECEVE 1123; L'Assistance Publique - Hopitaux de Paris (AP-HP)Active, not recruitingRecovery | Organization of Health Service | Mental Health Services | Mental Health CareFrance
-
King's College LondonCompletedMental Health Wellness 1 | Mental Health IssueUnited Kingdom
-
Universidad Metropolitana de Ciencias de la EducacionNot yet recruitingMental Health | Physical Inactivity | Cardiovascular Health | Mental Health Care | Sedentary BehaviorsChile
-
VA Office of Research and DevelopmentCompletedMental Health | Veterans Health | Rural HealthUnited States
-
Cambridge Health AllianceNot yet recruitingMental Health | Adolescent Health | Minority Health | Community Health Services
-
Chapin Hall at the University of ChicagoUniversity of ConnecticutCompletedMental Health | Physical Health
-
Chinese University of Hong KongRecruitingMental Health Wellness 1 | Mental Well-being | Mental Health Issue | Precision Mental HealthHong Kong
-
Chinese University of Hong KongThe University of Hong Kong; The Hong Kong Polytechnic University; The Hong Kong... and other collaboratorsRecruitingMental Well-being | Adolescent Health | Mental Health Help-Seeking | Mental Health Literacy | School Difficulties Associated With Mental Health ProblemsHong Kong
Clinical Trials on "EspaiJove.net" mental health literacy program
-
Chinese University of Hong KongNot yet recruitingMental Health IssueHong Kong
-
Universidad de ValparaisoCompletedChild Mental HealthChile
-
Universidad de ValparaisoRecruitingMental Health LiteracyChile, Ecuador
-
Tokyo UniversityCompletedHelp-Seeking Behavior | Mental Health Literacy | Stigma of Mental IllnessJapan
-
University of CoimbraNot yet recruitingChronic Pain | Mental Health | Health LiteracyPortugal
-
Assiut UniversityNot yet recruitingMental Health | Help-Seeking Behavior | Mental Health Literacy | Stigma of Mental Illness | Adolescent Mental Health
-
Norwegian School of Sport SciencesNorwegian association for youth mental health; Østfold University CollegeCompletedBody Weight | Mental Health | Coping Behavior | Depression, Anxiety | Perfectionism | Body Image | Mental Health Impairment | Eating Disorders | Self EsteemNorway
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, FranceNot yet recruiting
-
Nereida Canosa RodríguezRecruiting
-
Abant Izzet Baysal UniversityNot yet recruitingEducation | Nurse's Role | Mental Health LiteracyTurkey