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NCT Number: NCT07796867

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Mental Health Behavior Emotional Well-being Personal Satisfaction Psychological Well-Being Resilience, Psychological

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sant Joan de Déu Barcelona / Institut de Recerca Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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).

Treatment and study plan

Henka program

Behavioral

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.

Primary outcomes

  1. Change in Resilience - adolescents

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

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

  2. Change in Resilience - families

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

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

  3. Change in school resilience - educational professionals

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

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

Secondary outcomes

  1. Change in coping strategies - adolescents

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

    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.

  2. Change in assertiveness - adolescents

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

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

  3. Change in perceived self-efficacy - adolescents

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

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

  4. Change in empathy - adolescents

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

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

  5. Change in emotional repair - adolescents

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

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

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

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

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

  7. Change in generalized anxiety - adolescents

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

    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).

  8. Change in depression - adolescents

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

    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).

  9. Change in school resilience - adolescents

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

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

  10. Change in positive parenting functioning - families

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

    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.

  11. Change in family climate - families

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

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

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

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

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

  13. Change in perceived stress - families

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

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

  14. Change in perception of student adjustment - educational professionals

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

    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.

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

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

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

  16. Change in perceived stress - educational professionals

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

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

  17. Adolescents' experiences and perspectives on the HENKA program

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

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

  18. Families' experiences and perspectives on the HENKA program

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

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

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

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

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

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

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

    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.

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Collaborators

  • Education Department (Catalonia)
  • Health Department (Catalonia)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 1, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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