"Promoting Health in Adolescents With and Without Chronic Diseases Through Emotional Development: Design and Implementation of a Serious Game Technology Platform (EmoTIChealth)"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Change Quality of Life (Baseline-Pre-Post)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent by parents/guardians and participants.
- •Aged between 12 and 16 years old
排除标准
- •No access to internet or new technologies
- •Not a Spanish speaker.
研究组 & 干预措施
Experimental group
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.
干预措施: EmoTIChealth (Behavioral)
结局指标
主要结局
Change Quality of Life (Baseline-Pre-Post)
时间窗: Baseline up to 8 weeks
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. \[Time Frame: Baseline up to 8 weeks\]
Change Emotional and Behavioral Problems (Baseline-Pre-Post)
时间窗: Baseline up to 8 weeks
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.
Change Emotional Competences (Baseline-Pre-Post)
时间窗: Baseline up to 8 weeks
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.
Change Self-concept (Baseline-Pre-Post)
时间窗: Baseline up to 8 weeks
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.
Change Coping (Baseline-Pre-Post)
时间窗: Baseline up to 8 weeks
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.
Change Social Skills (Baseline-Pre-Post)
时间窗: Baseline up to 8 weeks
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.
次要结局
- 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)
研究者
M. Antonia Pérez-Marín
Associate Professor
University of Valencia