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Health LiteracyNCT03872817

Psychoeducational Intervention to Promote Adolescents' Mental Health Literacy in a School Context

A study testing Intervention ProLiSMentAl in people with Health Literacy, run by Escola Superior de Enfermagem de Coimbra.

Completed

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

Official record
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Trial summary

Mental Health Literacy was defined as knowledge and beliefs about mental disorders that aid in its recognition, management or prevention. Portugal is the European country with the highest prevalence of mental illness in the population (22.9%) and anxiety disorders are the most common (16.5%). Read more about this study

Who is it for?
Ages 14 to 17 years
Conditions the study is for
Health Literacy
What is being tested?
Intervention ProLiSMentAl
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
No sites listed yet
Study dates
2 Feb 2016to 31 May 2016
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 14 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • All adolescents', students from 9th grade with informed consent.

Who cannot join

  • students with special needs;
  • students of other years of schooling
  • students without informed consent.

About this study

Official title: Development and Piloting of a Psychoeducational Intervention to Promote Mental Health Literacy in Adolescents in a School Context

Mental Health Literacy was defined as knowledge and beliefs about mental disorders that aid in its recognition, management or prevention. Portugal is the European country with the highest prevalence of mental illness in the population (22.9%) and anxiety disorders are the most common (16.5%). Approximately 20% of children and adolescents suffer from some mental disorder and about 8% of adolescents aged 13 to 18 years have some anxiety disorders. Portugal School Health Program 2015 evidences the promotion of health literacy and anxiety as areas of intervention in adolescence. The investigators intend to know the feasibility of a psychoeducational intervention to promote adolescents' mental health literacy (MHL) about anxiety in a school context.

Read the detailed description

Mental Health Literacy (MHL) was defined as knowledge and beliefs about mental disorders that aid in its recognition, management or prevention and include several components: recognition of disorders to facilitate help-seeking; knowledge of professional help and treatments available; knowledge of effective self-help strategies; knowledge and skills to give first aid and support to others, and knowledge of how to prevent mental disorders. MHL is not simply knowledge of mental health problems, it is knowledge linked to action which can benefit one's own mental health or that of others. Portugal is the European country with the highest prevalence of mental illness in the population (22.9%) and anxiety disorders are the most common (16.5%). Approximately 20% of children and adolescents suffer from some mental disorder and about 8% of adolescents aged 13 to 18 years have some anxiety disorders. In a Portugal recent study, anxiety predominated in 66.3% (930) adolescents between the ages of 13 and 17 who used the urgency of a pediatric hospital from 2011 to 2014. Portugal School Health Program (2015) evidences the promotion of health literacy and anxiety as areas of intervention in adolescence.

The objectives of this study are: identify adolescents' MHL about anxiety in school setting; design an psychoeducational intervention to promote adolescents' MHL about anxiety in school setting; validate the content of that intervention and evaluate its feasibility.

Research Method(s): Medical Research Council's (MRC) framework and CReDECI Checklist were applied on the development and evaluation of complex interventions using quantitative, qualitative and mixed methods. Ethical considerations have taken place.

Implementation Strategies for Findings: Development of psychoeducational intervention to promote adolescents' MHL about anxiety in school setting supported by Health Promotion Model of Pender; Conceptual Model of Health Literacy and Integrative Model of Behavioral Prediction. Systematic reviews about adolescents' MHL and about MHL interventions showed reduced mental health literacy of adolescents and suggest some methods and pedagogical techniques. We designed a mental health literacy psychoeducational intervention about anxiety on adolescents in a school context called "ProLiSMentAl" using different methods and pedagogical techniques, consist of 4 sessions of 90 minutes: 1) Improvement social anxiety recognition; 2) prevention strategies; 3) self-help strategies; 4) knowledge of first aid strategies and 5) knowledge of professionals and treatments available. Contextual factors and determinants of the setting in the modelling of the intervention were given by a focus group with 6 health and education experts and a focus group with 6 adolescents and an e-delphi with 25 experts. After nurses' training and preparation meetings, mixed studies were carried out to model the final intervention and determine feasibility, acceptability and practicability of this complex intervention: 1) feasibility study: pre-experimental, before and after, without control group with 11 adolescents; 2) adolescents', health and education professionals' evaluation; 3) pilot study: quasi-experimental, before, after and 1month follow-up (n=21) with an equivalent control group (n=17).

Conditions
Health Literacy
Being tested
Intervention ProLiSMentAl
Keywords
Mental Health, Health Literacy, Adolescent, Schools
Medical subject headings
Psychological Well-Being

What participants receive

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

  • Intervention ProLiSMentAlOther

    Using different methods and pedagogical techniques, mental health literacy psychoeducational intervention called "ProLiSMentAl" consist of 4 sessions of 90 minutes: 1) improvement social anxiety recognition; 2) prevention strategies; 3) self-help strategies; 4) knowledge of first aid strategies and 5) knowledge of professionals and treatments available.

Study groups in NCT03872817
Study groupRoleWhat they receive
Intervention ProLiSMentAlExperimentalExperimental Group receive mental health literacy psychoeducational intervention called "ProLiSMentAl" that consist of 4 sessions of 90 minutes.
Receives: Other: Intervention ProLiSMentAl
Control GroupNo interventionControl Group receive usual approach.

What is being measured

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

  1. Feasibility of a psychoeducational intervention to promote adolescents' mental health literacy about anxiety in school setting using mental health literacy questionnaires.

    Improvement and change of adolescents' mental health literacy from baseline, measured before, immediately following the psychoeducational intervention and 1 month follow-up.

    Measuring instruments: Mental Health Literacy Questionnaire.

    Treatment and analysis of data: content analysis and IBM SPSS Statistics 24.0

    Measured: Before, immediately following the psychoeducational intervention and 1 month follow-up

Timeline

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

  1. First posted13 Mar 2019
  2. Study start2 Feb 2016
  3. Primary completion13 Mar 2016
  4. Study completion31 May 2016

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
Non-randomised
Intervention model
Parallel groups
Model description
Participants are assigned in two groups, an experimental group who will receive the psychoeducational intervention "ProLiSMentAl" and a control group who have usual intervention
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03872817
Sponsor's protocol ID
71/2015
Status last verified
Mar 2019
First submitted
11 Feb 2019
Last updated
13 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jorm AF, Korten AE, Jacomb PA, Christensen H, Rodgers B, Pollitt P. "Mental health literacy": a survey of the public's ability to recognise mental disorders and their beliefs about the effectiveness of treatment. Med J Aust. 1997 Feb 17;166(4):182-6. doi: 10.5694/j.1326-5377.1997.tb140071.x.

    PubMed 9066546

  • Jorm AF. Improving the mental health of the population: where to next? Med J Aust. 2014 Jul 7;201(1):23-4. doi: 10.5694/mja14.00509. No abstract available.

    PubMed 24999880

  • Jorm AF. Mental health literacy: empowering the community to take action for better mental health. Am Psychol. 2012 Apr;67(3):231-43. doi: 10.1037/a0025957. Epub 2011 Oct 31.

    PubMed 22040221

  • Jorm AF. Mental health literacy. Public knowledge and beliefs about mental disorders. Br J Psychiatry. 2000 Nov;177:396-401. doi: 10.1192/bjp.177.5.396.

    PubMed 11059991

  • Loureiro LM. Questionnaire for Assessment of Mental Health Literacy - QuALiSMental: study of psychometric properties. Revista de Enfermagem Referência serIV(4): 79-88, 2015. https://dx.doi.org/10.12707/RIV14031

  • Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013 May;50(5):587-92. doi: 10.1016/j.ijnurstu.2012.09.010. Epub 2012 Nov 15. No abstract available.

    PubMed 23159157

  • Morgado T, Loureiro L, Rebelo Botelho MA, Marques MI, Martinez-Riera JR, Melo P. Adolescents' Empowerment for Mental Health Literacy in School: A Pilot Study on ProLiSMental Psychoeducational Intervention. Int J Environ Res Public Health. 2021 Jul 29;18(15):8022. doi: 10.3390/ijerph18158022.

    PubMed 34360315

Questions about this trial

What is this clinical trial studying?

A study testing Intervention ProLiSMentAl in people with Health Literacy, run by Escola Superior de Enfermagem de Coimbra.

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 1 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 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Feasibility of a psychoeducational intervention to promote adolescents' mental health literacy about anxiety in school setting using mental health literacy questionnaires. (time frame: Before, immediately following the psychoeducational intervention and 1 month follow-up). 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 NCT03872817, which also lists 7 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 13 Mar 2019.

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