AzTrials
AzTrials

Mental HealthNCT03215654

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

A study testing "EspaiJove.net" mental health literacy program in people with Mental Health and Stigma, Social, run by Centre d'Higiene Mental Les Corts at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 13 to 18 years
Conditions the study is for
Mental Health, Stigma, Social
What is being tested?
"EspaiJove.net" mental health literacy program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
432 participants
Where
2 sitesSpain
Study dates
2 Oct 2017to 22 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Centre Higiene Mental Les Corts

    Barcelona, 08029

  • Rocio Casañas

    Barcelona, 08029

Other trials in Spain

About this study

Official title: "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.

Read more

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.

Being tested
"EspaiJove.net" mental health literacy program
Keywords
mental health, promotion, prevention, adolescence, school programs, intervention
Medical subject headings
Psychological Well-Being, Social Stigma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "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.

Study groups in NCT03215654
Study groupRoleWhat they receive
Sensitization Program (SP)ExperimentalInclude the concepts of mental health and mental disorder, healthy and risky behaviors of mental health, and use of health services. Duration 1 hour.
Receives: Other: "EspaiJove.net" mental health literacy program
Mental Health Literacy Program (MHL)ExperimentalMHL 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.
Receives: Other: "EspaiJove.net" mental health literacy program
MHL more Stigma Reduction (ER)ExperimentalIncludes 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.
Receives: Other: "EspaiJove.net" mental health literacy program
Control groupNo interventionControl 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Change in the Scaling Community Attitudes toward the Mentally Ill (CAMI).

    Behaviour and Attitudes towards Mental health ( stigma)

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

Secondary outcomes (9)

  1. Change in the Mental health symptoms and emotional well-being

    The Strengths and Difficulties Scale (SDQ) will assess mental health symptoms and emotional well-being.

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

  2. Change in the Bullying and Cyberbullying questionnaire

    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.

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

  3. Change in the Quality of life

    We will use a Spanish validated version of the EuroQol 5D-5L questionnaire (EQ-5D-5L)

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

  4. Change in the Intentions to Change

    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.

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

  5. Change in the Help-seeking

    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.

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

  6. Change in the Use of Health Services and Treatment

    We developed a 8- ítems questionnaire to evaluate the use of health services and treatment

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

  7. Health Benefits Questionnaire

    We developed a 17-items questionnaire to evaluate family, academic and general health benefits.

    Measured: Baseline

  8. Acceptability and satisfaction of 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.

    Measured: 2 weeks after the intervention

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

    Behaviour and Attitudes towards Mental health ( stigma)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2017
  2. Study start2 Oct 2017
  3. Primary completion15 Mar 2018
  4. Study completion22 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
432 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03215654
Sponsor's protocol ID
PI15/01613
Status last verified
Jul 2019
First submitted
4 Jul 2017
Last updated
25 Jul 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36566192

  • 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.

    PubMed 30064404

Questions about this trial

What is this clinical trial studying?

A study testing "EspaiJove.net" mental health literacy program in people with Mental Health and Stigma, Social, run by Centre d'Higiene Mental Les Corts at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03215654, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in