NCT07796867

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,084

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jan 2024Dec 2026

Study Start

First participant enrolled

January 1, 2024

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

September 14, 2026

Status Verified

September 1, 2026

Enrollment Period

3 years

First QC Date

August 27, 2026

Last Update Submit

September 9, 2026

Conditions

Keywords

adolescentsresilienceschool-based preventionuniversal prevention programmental health promotionfamiliesteachersnon-randomized cluster-controlled trialmixed-methodsqualitative researchfocus groups

Outcome Measures

Primary Outcomes (3)

  • Change in Resilience - adolescents

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

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

  • Change in Resilience - families

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

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

  • 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.

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

Secondary Outcomes (20)

  • Change in coping strategies - adolescents

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

  • Change in assertiveness - adolescents

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

  • Change in perceived self-efficacy - adolescents

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

  • Change in empathy - adolescents

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

  • Change in emotional repair - adolescents

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

  • +15 more secondary outcomes

Study Arms (2)

HENKA Intervention Group

EXPERIMENTAL

Schools 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.

Behavioral: Henka program

Control Group

NO INTERVENTION

Schools 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.

Interventions

Henka programBEHAVIORAL

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.

HENKA Intervention Group

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Related Links

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Claudia Palma-Vasquez, PhD

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

    STUDY DIRECTOR
  • Ester Camprodon Rosanas, PhD

    Hospital Sant Joan de Déu Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Medical Director; HENKA Strategy Director

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 1, 2026

Study Start

January 1, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

September 14, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations