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Active, not recruiting

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 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

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 (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 BxB, RBEC and PSiE programs), 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: No

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

Inclusion criteria

  • Enrolled in a lower secondary school (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.

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.

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

  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

  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

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)

  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

  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

  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

  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

  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

  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

  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

  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

  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)

  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)

  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

  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

  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

  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

  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

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Collaborators

  • Education Department (Catalonia)
  • Health Departament (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.

Acronym: Henka

Important dates

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