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HENKA: Growing in Emotional Well-being

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07796867
Enrollment
1084
Registered
2026-09-01
Start date
2024-01-01
Completion date
2026-12-30
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotional Well-being, Mental Health, Resilience, Psychological

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

Brief 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. 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.

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.

Interventions

BEHAVIORALHenka program

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.

Sponsors

Fundació Sant Joan de Déu
Lead SponsorOTHER
Education Department (Catalonia)
CollaboratorUNKNOWN
Health Department (Catalonia)
CollaboratorUNKNOWN

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in Resilience - adolescentsFrom baseline (T0) to 3-month and 12-month follow-upResilience Scale for Adolescents (READ), 28 items, mean item score, theoretical range 1- 5. Higher scores indicate greater resilience.
Change in Resilience - familiesFrom baseline (T0) to 3-month and 12-month follow-upResilience Scale for Adults (RSA-33), 33 items, mean item score, theoretical range 1- 5. Higher scores indicate greater resilience.
Change in school resilience - educational professionalsFrom baseline (T0) to 3-month and 12-month follow-upSchool Resilience Scale (SRS), 20 items, mean item score, theoretical range 1- 5. Higher scores indicate greater school resilience.

Secondary

MeasureTime frameDescription
Change in coping strategies - adolescentsFrom baseline (T0) to 3-month and 12-month follow-upCoping 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.
Change in assertiveness - adolescentsFrom baseline (T0) to 3-month and 12-month follow-upAssertive Interpersonal Schema Questionnaire (AISQ), 21 items, sum score, theoretical range 21- 115. Higher scores indicate greater assertiveness.
Change in perceived self-efficacy - adolescentsFrom baseline (T0) to 3-month and 12-month follow-upGeneral Self-Efficacy Scale (EAG), 10 items, mean item score, theoretical range 1- 5. Higher scores indicate greater perceived self-efficacy.
Change in empathy - adolescentsFrom baseline (T0) to 3-month and 12-month follow-upBasic Empathy Scale, brief version (BES-B), 9 items, mean item score, theoretical range 1- 5. Higher scores indicate greater empathy.
Change in emotional repair - adolescentsFrom baseline (T0) to 3-month and 12-month follow-upTrait Meta-Mood Scale, emotional repair subscale (TMMS-24), 8 items, mean item score, theoretical range 1- 5. Higher scores indicate better emotional repair.
Change in psychological well-being/distress - adolescentsFrom baseline (T0) to 3-month and 12-month follow-upGeneral Health Questionnaire (GHQ-12), 12 items, sum score (binary scoring method), theoretical range 0- 12. Higher scores indicate greater psychological distress (worse outcome).
Change in generalized anxiety - adolescentsFrom baseline (T0) to 3-month and 12-month follow-upGeneralized Anxiety Disorder scale (GAD-7), 7 items, sum score, theoretical range 0-21. Higher scores indicate greater severity of generalized anxiety symptoms (worse outcome).
Change in depression - adolescentsFrom baseline (T0) to 3-month and 12-month follow-upPatient Health Questionnaire for adolescents (PHQ-9), 9 items, sum score, theoretical range 0- 27. Higher scores indicate greater severity of depressive symptoms (worse outcome).
Change in school resilience - adolescentsFrom baseline (T0) to 3-month and 12-month follow-upSchool Resilience Scale (SRS), 20 items,mean item score, theoretical range 1- 5. Higher scores indicate greater school resilience.
Change in positive parenting functioning - familiesFrom baseline (T0) to 3-month and 12-month follow-upParental 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.
Change in family climate - familiesFrom baseline (T0) to 3-month and 12-month follow-upFamily Environment Scale (FES), 27 items, 3 subscales (cohesion, expressiveness, conflict), sum score, theoretical range 0- 27. Higher scores indicate better family climate.
Change in psychological well-being/distress - familiesFrom baseline (T0) to 3-month and 12-month follow-upGeneral Health Questionnaire (GHQ-12), 12 items, sum score (binary scoring method), theoretical range 0- 12. Higher scores indicate greater psychological distress (worse outcome).
Change in perceived stress - familiesFrom baseline (T0) to 3-month and 12-month follow-upPerceived Stress Scale (PSS-10), 10 items, sum score, theoretical range 0- 40. Higher scores indicate greater perceived stress (worse outcome).
Change in perception of student adjustment - educational professionalsFrom baseline (T0) to 3-month and 12-month follow-upTeacher'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.
Change in psychological well-being/distress - educational professionalsFrom baseline (T0) to 3-month and 12-month follow-upGeneral Health Questionnaire (GHQ-12), 12 items, sum score (binary scoring method), theoretical range 0-12. Higher scores indicate greater psychological distress (worse outcome).
Change in perceived stress - educational professionalsFrom baseline (T0) to 3-month and 12-month follow-upPerceived Stress Scale (PSS-10), 10 items, sum score, theoretical range 0 - 40. Higher scores indicate greater perceived stress (worse outcome).
Adolescents' experiences and perspectives on the HENKA programSecond and third trimesters of the 2024-2025 and 2025-2026 academic yearsThemes identified from semi-structured focus group discussions with adolescents, analyzed using thematic analysis within a phenomenological framework.
Families' experiences and perspectives on the HENKA programSecond and third trimesters of the 2024-2025 and 2025-2026 academic yearsThemes identified from semi-structured focus group discussions with families, analyzed using thematic analysis within a phenomenological framework.
Educational professionals' experiences and perspectives on the HENKA programSecond and third trimesters of the 2024-2025 and 2025-2026 academic yearsThemes identified from semi-structured focus group discussions with educational professionals, analyzed using thematic analysis within a phenomenological framework.
Key regional well-being stakeholders' experiences and perspectives on the HENKA programSecond and third trimesters of the 2024-2025 and 2025-2026 academic yearsThemes 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.

Countries

Spain

Contacts

STUDY_DIRECTORClaudia Palma-Vasquez, PhD

PRISMA Research Group, Institut de Recerca Sant Joan de Déu (IRSJD)

PRINCIPAL_INVESTIGATOREster Camprodon Rosanas, PhD

Hospital Sant Joan de Déu Barcelona

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026