EmoTIChealth: Promoting Adolescent Health Through a Serious Game.

NCT07212530 | Not Yet Recruiting

• 1 other identifier: EmoTIChealth
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The intervention program targets adolescents between 12 and 16 years of age. The intervention program is designed for adolescents during a critical developmental stage marked by significant life transitions, where building strong personal resources and receiving psychological support is essential to foster socioemotional skills and overall well-being. The serious game aims to promote psycho-emotional health in the general adolescent population, supporting healthy development and preventing future emotional difficulties. At the same time, it incorporates specific modules for adolescents living with chronic conditions such as asthma, food allergy, type 1 diabetes, and allergic rhinitis, who may face additional risks of psychological challenges that can complicate treatment and prognosis. By combining universal health promotion with tailored support, the program addresses both the needs of healthy adolescents and those with chronic illnesses. The platform integrates digital and technological tools for dynamic and personalized intervention. Artificial intelligence adapts activities and feedback to each participant's socio-demographic profile and evolving needs, this supports directly in participants' daily lives and natural environments, making the experience more relevant and impactful. The serious game, proven effective in engaging young people, goes beyond traditional psychoeducation by creating an interactive environment where adolescents develop socio-emotional competencies, resilience, and health-related knowledge. Through its six thematic areas, the game promotes overall well-being and healthy habits, while its condition-specific modules provide targeted guidance and coping strategies for asthma, food allergies, type 1 diabetes, and allergic rhinitis.

Conditions

Type 1 Diabetes; Asthma; Allergic Rhinitis; Food Allergy; Adolescent Development

Keywords

Type 1 Diabetes; Asthma; Allergic Rhinitis; Food allergy; Serious Game; Technology platform; Psychological intervention; Adolescence; Quality of life; chronic organic illnesses; Socioemotional Education; Health Promotion

Outcome Measures

Primary Outcomes (6)

• Change Quality of Life (Baseline-Pre-Post)

  KIDSCREEN-27. This scale consists of 27 items in 5 subscales. Physical well-being, mood, family life, school life, peer relations. Scores range from 27 to 135. Higher scores indicate a higher quality of life in general and in each of the subscales. First measurement: After the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: PRE- Up to 4 weeks after the first measurement, the second measurement of the same variable was carried out. Third measurement: POST Up to 4 weeks after the second measurement, the third measurement of the same variable was carried out. \[Time Frame: Baseline up to 8 weeks\]

  Baseline up to 8 weeks

• Change Emotional and Behavioral Problems (Baseline-Pre-Post)

  SDQ: This questionnaire is used to assess the possible presence of psychopathology and the emotional and behavioral adjustment of adolescents. It is a 25-item Likert-type (1-3) questionnaire. The items of this questionnaire are divided into 5 subscales: emotional symptomatology, conduct problems, hyperactivity, peer problems and prosocial behavior. Higher scores on each scale indicate greater difficulties. First measurement: After the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: PRE- Up to 4 weeks after the first measurement, the second measurement of the same variable was carried out. Third measurement: POST Up to 4 weeks after the second measurement, the third measurement of the same variable was carried out.

  Baseline up to 8 weeks

• Change Emotional Competences (Baseline-Pre-Post)

  EAQ-30: This questionnaire consists of 30 Likert-style items (1-False to 3-True), and aims to identify how adolescents think about their feelings, as well as the degree to which they feel them and the ability to express them. In addition to an overall score, this tool is composed of 6 subscales that attempt to describe different aspects of emotional functioning. Higher scores indicate greater use of emotional awareness and regulation strategies. First measurement: After the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: PRE- Up to 4 weeks after the first measurement, the second measurement of the same variable was carried out. Third measurement: POST Up to 4 weeks after the second measurement, the third measurement of the same variable was carried out.

  Baseline up to 8 weeks

• Change Self-concept (Baseline-Pre-Post)

  CAG: This questionnaire aims to measure self-concept in adolescents from a multidimensional perspective. It consists of 48 Likert-type response items ranging from 1 to 5, providing a score range of 48 to 240. Physical Self-Concept, Social Acceptance, Family Self-Concept, Intellectual Self-Concept, Personal Self-Assessment, and Sense of Control. The questionnaire provides an overall self-concept score, as well as scores for 6 subdimensions: Higher scores indicate higher self-concept. This is the first measurement. After obtaining the participant's informed consent, we assessed the initial score for this outcome. The second measurement, labeled PRE, was conducted up to 4 weeks after the first measurement of the same variable. The third measurement, labeled POST, was carried out up to 4 weeks after the second measurement.

  Baseline up to 8 weeks

• Change Coping (Baseline-Pre-Post)

  Social Problem-Solving Inventory- Revised (SPSI-R). This questionnaire attempts to reflect the cognitive, affective and behavioral responses to the problems of daily life or the different difficulties we try to solve. This reduced version consists of 25 Likert-type items, grouped into the following 5 dimensions: Rational problem solving, Avoidant style, Impulsive style, Positive problem orientation and Negative problem orientation. Higher scores on each dimension signify the coping style used by the adolescent. First measurement: After the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: PRE- Up to 4 weeks after the first measurement, the second measurement of the same variable was carried out. Third measurement: POST Up to 4 weeks after the second measurement, the third measurement of the same variable was carried out.

  Baseline up to 8 weeks

• Change Social Skills (Baseline-Pre-Post)

  CHASO: It consists of 40 Likert-type response items ranging from 1 to 5 (1 - Very uncharacteristic of me; 5 - Very characteristic of me) and assesses a total of 10 skills: 1. Interacting with strangers; 2. Dealing with criticism; 4. Interacting with people I am attracted to; 5. Staying calm in the face of criticism; 6. Public speaking/interacting with superiors; 7. The scores for each of these skills are calculated from the sum of the items that make them up. Higher scores indicate higher social skills. First measurement: After the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: PRE- Up to 4 weeks after the first measurement, the second measurement of the same variable was carried out. Third measurement: POST Up to 4 weeks after the second measurement, the third measurement of the same variablewas carried out.

  Baseline up to 8 weeks

Secondary Outcomes (5)

• Change in Perception of Threat of disease(Baseline-Pre-Post)

  Baseline up to 8 weeks

• Change Psychoeducation Diabetes

  Start of the intervetion and during it.

• Change Resilience (Baseline-Pre-Post)

  Baseline up to 8 weeks

• Outcome Measure: Change in Perceived Importance of Health Habits (Baseline-Pre-Post)

  Baseline up to 8 weeks

• Outcome Measure: Assessment of the intervention and change in the emotional state of the participants

  Baseline up to 8 weeks

Study Arms (1)

Experimental group

EXPERIMENTAL

Adolescents who receive the treatment program will previously constitute their own control group (waiting list control group). Thus, diagnostic measures will be obtained in all of them in an initial evaluation (T1), and after 4 weeks of this assessment the treatment program will be started. In the first contact session, 4 weeks after T1, all adolescents will be reassessed (T2), and after this, the treatment program will be started (within an estimated time of 10 days maximum from this second pre-treatment evaluation, the estimated duration of play/treatment being 4 weeks). After the completion of the serious game, a new asssesment pass will be performed (T3) in order to review the post-treatment change. Thus, the estimated time between T2 and T3 will be equivalent to that between T1 and T2, being 4 weeks.

Behavioral: EmoTIChealth

Interventions

EmoTIChealth BEHAVIORAL

The EmoTIChealth technological platform intervenes in users through a "serious game", i.e. a video game whose main purpose is to teach or provide the player with certain skills that serve to achieve a higher purpose than the game itself. The game is composed of 6 areas, each of which refers to one of the variables that are analyzed or considered important in promoting health related quality of life and adaptation to chronic illness: Area 1. Psychoeducation; 2. Emotional awareness and expression; 3. Emotional regulation; 4. Problem solving; 5. Self-esteem and identity;6. Social skills and communication.

Experimental group

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Informed consent by parents/guardians and participants.
• Aged between 12 and 16 years old

You may not qualify if:

• No access to internet or new technologies
• Not a Spanish speaker.

Sponsors & Collaborators

• University of Valencia: lead
• Universitat Politècnica de València: collaborator

Study Sites (1)

Facultat de Psicología

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Asthma; Rhinitis, Allergic; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Study Officials

• Marián Pérez-Marín, PHD

  Universitat de Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marián Pérez-Marín, PHD

CONTACT

0034 9639; marian.perez@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)