An interventional study of EmoTIChealth in Type 1 Diabetes, Asthma and Allergic Rhinitis, sponsored by University of Valencia. Recruiting at 1 site in Spain. Open to participants aged 12 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by University of Valencia · Not applicable, Interventional, and Prevention
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 600 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University of Valencia is the lead sponsor of 357 studies on the registry; 75 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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. \[Time Frame: Baseline up to 8 weeks\]
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to 8 weeks
Change in Perception of Threat of disease(Baseline-Pre-Post)
The Brief Illness Threat Questionnaire (BIP-Q) is used, which consists of 5 items with a Likert scale from 0 to 10. This questionnaire mainly assesses consequences of the illness, duration of the illness, identity, worry about the illness and emotional impact of the illness. The scale is interpreted so that the higher the score, the greater the sense of perceived threat. 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 6 weeks after the second measurement, the third measurement of the same variable was carried out.
Time frame: Baseline up to 8 weeks
Change Psychoeducation Diabetes
Psychoeducation of the disease: the ECODI Diabetes knowledge scale will be used to assess this variable. This scale consists of 25 items and four dimensions: basic knowledge and self-care, laboratory values, diet and physical exercise. It is a scale that is corrected by the number of hits and misses. Psychoeducation about the disease: The ECODI diabetes knowledge scale is used to assess this variable. This scale consists of 25 items and four dimensions: basic knowledge and self-care, laboratory values, diet and exercise. It is a scale that is corrected by the number of hits and misses.
Time frame: Start of the intervetion and during it.
Change Resilience (Baseline-Pre-Post)
Connor-Davidson Resilience Scale to assess the ability to cope with stress and adversity. The resilience scale is made up of 10 items, with a range of scores from 0 to 40, with higher scores indicating greater resilience. First measurement: Once 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
Outcome Measure: Change in Perceived Importance of Health Habits (Baseline-Pre-Post)
A self-report questionnaire specifically developed for this study will be used to assess adolescents' perceived importance of maintaining healthy habits. The instrument consists of 16 Likert-type items (1 = Not important at all to 5 = Extremely important) that evaluate three domains: 1. Nutrition (e.g., balanced diet, regular meal patterns). 2. Hygiene (e.g., daily personal hygiene routines). 3. Physical exercise (e.g., regular engagement in physical activity). 4. Healthy sleep habits (e.g. sleeping at least 8 hours, having a defined schedule.) Higher scores indicate greater perceived importance attributed to healthy behaviors across the three domains, with a total score ranging from 16 to 80. Subscale scores will also be calculated for each domain. First measurement (T1): Baseline, after informed consent. Second measurement (T2): Approximately 4 weeks after baseline (pre-intervention re-assessment). Third measurement (T3): Approximately 4 weeks after T2 (post-intervention assessment)
Time frame: Baseline up to 8 weeks
Outcome Measure: Assessment of the intervention and change in the emotional state of the participants
These items aim to assess the intervention from the perspective of adolescents, specifically in terms of the extent to which it has helped them in different areas of their daily lives. There will be a total of 13 Likert-type items ranging from 0 (it has not helped me at all) to 10 (it has helped me a lot). These items will only be collected at the final time point (T3), i.e. after the intervention has been completed. The degree of difficulty experienced in their lives and their emotional state will also be evaluated using six Likert scale items ranging from 0 to 10. Information on these difficulties and emotional state assessments will be collected at the three assessment points (T1, T2 and T3). First measurement (T1): Baseline, after informed consent. Second measurement (T2): Approximately 4 weeks after baseline (pre-intervention re-assessment). Third measurement (T3): Approximately 4 weeks after T2 (post-intervention assessment).
Time frame: Baseline up to 8 weeks
Plan to share: No
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Started Dec 2025 (actual). Primary completion is estimated for Aug 2027, 20 months after the start.
Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 20 months is close to that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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