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Mental HealthNCT07796867

HENKA: Growing in Emotional Well-being

A study testing Henka program in people with Mental Health and Resilience, Psychological, run by Fundació Sant Joan de Déu at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

HENKA is a universal, whole-community, school-based program that aims to promote emotional well-being and prevent mental health problems among adolescents enrolled in 1st to 3rd year of Secondary Education (ESO) in Catalonia, Spain (approximately 12 to 16 years old), through the development of resilience. Read more about this study

Who is it for?
Ages 11 years and olderHealthy volunteers can take part
What is being tested?
Henka program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,084 participants
Where
1 siteSpain
Study dates
1 Jan 2024to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 11 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Enrolled in Compulsory Secondary Education (ESO) in Catalonia, Spain.
  • Adolescents enrolled in 1st, 2nd or 3rd year of ESO.
  • Adolescents under 18 provide assent to participate; parents/guardians provide written informed consent.
  • Parents/guardians and teachers who sign informed consent participate in the program evaluation.
  • Representatives from the Wellbeing for Being Well Program (BxB), Community Emotional Well-being Representatives (RBEC), or Health and School Program (PSiE) who have collaborated with the HENKA program in Catalonia and sign informed consent (qualitative phase only).

Who cannot join

  • Parents/guardians who do not sign informed consent for minors under 18.
  • Adolescents who do not assent to participate.
  • Parents/guardians who do not sign their own informed consent.
  • Teachers who do not sign their informed consent.
  • Representatives or professionals from any of the three programs (BxB, RBEC, or PSiE) who do not sign informed consent (qualitative phase only).

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Sant Joan de Déu Barcelona / Institut de Recerca Sant Joan de Déu

    Esplugues de Llobregat, Barcelona, 08950

Other trials in Spain

About this study

Official title: Evaluation of the Effectiveness of a Promotion and Prevention Project in Child and Youth Mental Health. HENKA: Growing in Emotional Well-being

HENKA is a universal, whole-community, school-based program that aims to promote emotional well-being and prevent mental health problems among adolescents enrolled in 1st to 3rd year of Secondary Education (ESO) in Catalonia, Spain (approximately 12 to 16 years old), through the development of resilience. The programme's name takes its origin from the Japanese term Henka, meaning a positive and transformative change, reflecting its focus on fostering sustainable improvements in adolescents' socioemotional functioning.The program targets adolescents, their families and school professionals. Its effectiveness is being evaluated through a non-randomized, two-arm, cluster-controlled quantitative phase (intervention schools compared to control schools), combined with a qualitative phase using focus groups. The study builds on the HENKA Pilot study (Ethics Committee code PIC-85-22), which assessed the feasibility of the evaluation process, including the validity of the assessment instruments and participants' viability and acceptability, before scaling up the program to a larger population.

Read the detailed description

The quantitative phase uses school-level cluster sampling: recruitment was coordinated with the Department of Education and the Department of Health of the Government of Catalonia, and schools voluntarily enrolled in either the HENKA intervention group (target at least 100 schools) or the control group (target at least 25 schools), depending on whether they formalized full participation in the program or chose to take part in the evaluation component only. The first-year secondary school cohort served as the sampling cluster, with additional cohorts progressively enrolled across successive academic years, starting in 2023-2024, until the target sample size was reached; each cohort was followed longitudinally until the third year of secondary school. The intervention comprises student training, consisting of eight approximately 55-minute classroom sessions covering self-efficacy/self-esteem, emotional self-regulation, assertiveness, interpersonal skills, and mindfulness. This training is delivered by teachers during school hours, and the teachers have previously received training from specialist staff (train-the-trainer program). In some sessions, teachers are accompanied by Community Emotional Well-being Representatives (RBEC), health professionals provided by the Department of Health who support classroom delivery and help identify and manage mental-health-related situations among students. Families attend parent workshops. Control schools continue with their usual mental health talks and resources and are offered the HENKA materials after the study ends. Results are assessed through validated online questionnaires (Research Electronic Data Capture, REDCap) at up to six time points over three academic years. A sample size calculation performed a priori with G*Power 3.1.9.7 (effect size 0.2, alpha 0.05, power 0.95) indicated a minimum of 1,084 participants (542 per control and intervention group). In addition, a qualitative phase is conducted through focus groups with each participant segment (adolescents, families, educational professionals, and key regional well-being stakeholders from the Wellbeing for Being Well Program (BxB), the Community Emotional Well-being Representatives program (RBEC), and the Health and School Program (PSiE), held during the second and third trimesters of the 2024-2025 and 2025-2026 academic years, to explore participants' experiences and perspectives on the HENKA program.

Being tested
Henka program
Keywords
adolescents, resilience, school-based prevention, universal prevention program, mental health promotion, families, teachers, non-randomized cluster-controlled trial, mixed-methods, qualitative research, focus groups
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.

  • Henka programBehavioural

    A universal, whole-community, school-based program to promote resilience and prevent mental health problems among adolescents. The program comprises eight approximately 55-minute classroom sessions covering self-efficacy/self-esteem, emotional self-regulation, assertiveness, interpersonal skills and mindfulness, delivered by teachers previously trained through the HENKA train-the-trainer program. In some sessions, teachers are accompanied by Community Emotional Well-being Representatives (RBEC), health professionals provided by the Department of Health who support classroom delivery and help identify and manage mental-health-related situations among students. Families are offered a parent workshop.

Study groups in NCT07796867
Study groupRoleWhat they receive
HENKA Intervention GroupExperimentalSchools that formalize participation in HENKA (~100 schools). Students receive 8 classroom sessions (55 min each) on self-efficacy, emotional self-regulation, assertiveness, interpersonal skills and mindfulness; teachers receive HENKA training; families are offered a 90-minute workshop.
Receives: Behavioral: Henka program
Control GroupNo interventionSchools that agree to participate in the evaluation only (~25 schools), continuing their usual mental-health-related talks and resources; they receive the HENKA materials to implement independently after the study ends.

What is being measured

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

  1. Change in Resilience - adolescents

    Resilience Scale for Adolescents (READ), 28 items, mean item score, theoretical range 1- 5. Higher scores indicate greater resilience.

    Measured: From baseline (T0) to 3-month and 12-month follow-up

  2. Change in Resilience - families

    Resilience Scale for Adults (RSA-33), 33 items, mean item score, theoretical range 1- 5. Higher scores indicate greater resilience.

    Measured: From baseline (T0) to 3-month and 12-month follow-up

  3. Change in school resilience - educational professionals

    School Resilience Scale (SRS), 20 items, mean item score, theoretical range 1- 5. Higher scores indicate greater school resilience.

    Measured: From baseline (T0) to 3-month and 12-month follow-up

Secondary outcomes (20)
  1. Change in coping strategies - adolescents

    Coping Strategies Scale for Adolescents (EA-A), 13 items (3 subscales: positive thinking/problem-solving 7 items, family support-seeking 3 items, peer support-seeking 3 items), mean item score, theoretical range 1- 5. Higher scores indicate greater use of adaptive coping strategies.

    Measured: From baseline (T0) to 3-month and 12-month follow-up

  2. Change in assertiveness - adolescents

    Assertive Interpersonal Schema Questionnaire (AISQ), 21 items, sum score, theoretical range 21- 115. Higher scores indicate greater assertiveness.

    Measured: From baseline (T0) to 3-month and 12-month follow-up

  3. Change in perceived self-efficacy - adolescents

    General Self-Efficacy Scale (EAG), 10 items, mean item score, theoretical range 1- 5. Higher scores indicate greater perceived self-efficacy.

    Measured: From baseline (T0) to 3-month and 12-month follow-up

  4. Change in empathy - adolescents

    Basic Empathy Scale, brief version (BES-B), 9 items, mean item score, theoretical range 1- 5. Higher scores indicate greater empathy.

    Measured: From baseline (T0) to 3-month and 12-month follow-up

  5. Change in emotional repair - adolescents

    Trait Meta-Mood Scale, emotional repair subscale (TMMS-24), 8 items, mean item score, theoretical range 1- 5. Higher scores indicate better emotional repair.

    Measured: From baseline (T0) to 3-month and 12-month follow-up

  6. Change in psychological well-being/distress - adolescents

    General Health Questionnaire (GHQ-12), 12 items, sum score (binary scoring method), theoretical range 0- 12. Higher scores indicate greater psychological distress (worse outcome).

    Measured: From baseline (T0) to 3-month and 12-month follow-up

  7. Change in generalized anxiety - adolescents

    Generalized Anxiety Disorder scale (GAD-7), 7 items, sum score, theoretical range 0-21. Higher scores indicate greater severity of generalized anxiety symptoms (worse outcome).

    Measured: From baseline (T0) to 3-month and 12-month follow-up

  8. Change in depression - adolescents

    Patient Health Questionnaire for adolescents (PHQ-9), 9 items, sum score, theoretical range 0- 27. Higher scores indicate greater severity of depressive symptoms (worse outcome).

    Measured: From baseline (T0) to 3-month and 12-month follow-up

  9. Change in school resilience - adolescents

    School Resilience Scale (SRS), 20 items,mean item score, theoretical range 1- 5. Higher scores indicate greater school resilience.

    Measured: From baseline (T0) to 3-month and 12-month follow-up

  10. Change in positive parenting functioning - families

    Parental Functioning Scale (EFP), 12 items, 3 subscales (communication-interaction, affective bond, co-parenting agreement), sum score, theoretical range 0- 6. Higher scores indicate better positive parenting functioning.

    Measured: From baseline (T0) to 3-month and 12-month follow-up

  11. Change in family climate - families

    Family Environment Scale (FES), 27 items, 3 subscales (cohesion, expressiveness, conflict), sum score, theoretical range 0- 27. Higher scores indicate better family climate.

    Measured: From baseline (T0) to 3-month and 12-month follow-up

  12. Change in psychological well-being/distress - families

    General Health Questionnaire (GHQ-12), 12 items, sum score (binary scoring method), theoretical range 0- 12. Higher scores indicate greater psychological distress (worse outcome).

    Measured: From baseline (T0) to 3-month and 12-month follow-up

  13. Change in perceived stress - families

    Perceived Stress Scale (PSS-10), 10 items, sum score, theoretical range 0- 40. Higher scores indicate greater perceived stress (worse outcome).

    Measured: From baseline (T0) to 3-month and 12-month follow-up

  14. Change in perception of student adjustment - educational professionals

    Teacher's Perception of Students Scale (PROF-A), 14 items, mean item score, theoretical range 1- 10. Higher scores indicate more positive teacher-perceived student adjustment.

    Measured: From baseline (T0) to 3-month and 12-month follow-up

  15. Change in psychological well-being/distress - educational professionals

    General Health Questionnaire (GHQ-12), 12 items, sum score (binary scoring method), theoretical range 0-12. Higher scores indicate greater psychological distress (worse outcome).

    Measured: From baseline (T0) to 3-month and 12-month follow-up

  16. Change in perceived stress - educational professionals

    Perceived Stress Scale (PSS-10), 10 items, sum score, theoretical range 0 - 40. Higher scores indicate greater perceived stress (worse outcome).

    Measured: From baseline (T0) to 3-month and 12-month follow-up

  17. Adolescents' experiences and perspectives on the HENKA program

    Themes identified from semi-structured focus group discussions with adolescents, analyzed using thematic analysis within a phenomenological framework.

    Measured: Second and third trimesters of the 2024-2025 and 2025-2026 academic years

  18. Families' experiences and perspectives on the HENKA program

    Themes identified from semi-structured focus group discussions with families, analyzed using thematic analysis within a phenomenological framework.

    Measured: Second and third trimesters of the 2024-2025 and 2025-2026 academic years

  19. Educational professionals' experiences and perspectives on the HENKA program

    Themes identified from semi-structured focus group discussions with educational professionals, analyzed using thematic analysis within a phenomenological framework.

    Measured: Second and third trimesters of the 2024-2025 and 2025-2026 academic years

  20. Key regional well-being stakeholders' experiences and perspectives on the HENKA program

    Themes identified from semi-structured focus group discussions with representatives of the Wellbeing for Being Well Program (BxB), the Community Emotional Well-being Representatives program (RBEC), and the Health and School Program (PSiE), analyzed using thematic analysis within a phenomenological framework.

    Measured: Second and third trimesters of the 2024-2025 and 2025-2026 academic years

Timeline

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

  1. First posted1 Sep 2026
  2. Study start1 Jan 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

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
Non-randomized, cluster-controlled, two-arm study, with the school as the unit of allocation. Recruitment was coordinated with the Department of Education and the Department of Health of the Government of Catalonia. Schools voluntarily enrolled in either the HENKA intervention group or the control group, depending on whether they formalized full participation in the program or chose to take part in the evaluation component only. Allocation was based on convenience (schools' willingness and capacity to implement the program), not randomization. All schools that requested to join the intervention group were accepted, without a cap on the number of participating schools. Baseline characteristics of control schools were reviewed for descriptive comparability with the intervention group, without a formal matching procedure. All eligible students, families and teachers within a participating school are exposed to the same condition (intervention or control). Qualitative phase has no arms.
Masking
None (open label)
Enrolment
1,084 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07796867
Sponsor's protocol ID
PIC-187-23
Status last verified
Sep 2026
First submitted
27 Aug 2026
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data sharing with external researchers has not been established as part of the current study protocol. Individual participant data include sensitive information on minors' mental health and are subject to strict confidentiality safeguards under Spanish data protection law (Ley Orgánica 3/2018). The research team may consider data sharing requests on a case-by-case basis in the future, subject to institutional and ethics committee approval.

Questions about this trial

What is this clinical trial studying?

A study testing Henka program in people with Mental Health and Resilience, Psychological, run by Fundació Sant Joan de Déu at 1 site 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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 Resilience - adolescents (time frame: From baseline (T0) to 3-month and 12-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 14 Sep 2026.

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