Hospital Sant Joan de Déu Barcelona / Institut de Recerca Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 08950, Spain
NCT Number: NCT07796867
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.
This study is active but is not currently recruiting participants.
Notify Me11 year and older
All sexes
Interventional
Not applicable
Esplugues de Llobregat, Barcelona, 08950, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Resilience Scale for Adolescents (READ), 28 items
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Resilience Scale for Adults (RSA-33), 33 items
Time frame: From baseline (T0) to 3-month and 12-month follow-up
School Resilience Scale (SRS), 20 items
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)
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Assertive Interpersonal Schema Questionnaire (AISQ), 21 items
Time frame: From baseline (T0) to 3-month and 12-month follow-up
General Self-Efficacy Scale (EAG), 10 items
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Basic Empathy Scale, brief version (BES-B), 9 items
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Trait Meta-Mood Scale, emotional repair subscale (TMMS-24), 8 items
Time frame: From baseline (T0) to 3-month and 12-month follow-up
General Health Questionnaire (GHQ-12), 12 items
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Generalized Anxiety Disorder scale (GAD-7), 7 items
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Patient Health Questionnaire for adolescents (PHQ-9), 9 items
Time frame: From baseline (T0) to 3-month and 12-month follow-up
School Resilience Scale (SRS), 20 items
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)
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Family Environment Scale (FES), 27 items, 3 subscales (cohesion, expressiveness, conflict)
Time frame: From baseline (T0) to 3-month and 12-month follow-up
General Health Questionnaire (GHQ-12), 12 items
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Perceived Stress Scale (PSS-10), 10 items
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Teacher's Perception of Students Scale (PROF-A), 14 items
Time frame: From baseline (T0) to 3-month and 12-month follow-up
General Health Questionnaire (GHQ-12), 12 items
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Perceived Stress Scale (PSS-10), 10 items
Fundació Sant Joan de Déu
Other
Evaluation of the Effectiveness of a Promotion and Prevention Project in Child and Youth Mental Health. HENKA: Growing in Emotional Well-being.
Acronym: Henka
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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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