Clinical trial NCT06331429: Emoticare: Serious Game for the Adaptation to the Disease of Adolescents With Type 1 Diabetes Mellitus.
Official title: Smart Technology Platform for Socio-emotional Development and Health Promotion: Implementation and Validation of a Serious Game in Adolescentes With DM1
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 1 Diabetes
Adolescent Development
Keywords: Type 1 Diabetes
Serious Game
Technology platform
Psychological intervention
Adolescence
Quality of life
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Universitat Politècnica de València
First posted: 2024-03-26
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The intervention program targets adolescents with chronic Type 1 Diabetes Mellitus. Given the critical developmental stage and life transitions, necessitating robust personal resources, psychological support becomes imperative. To foster socioemotional skills and overall well-being, particularly crucial for averting future emotional issues and promoting a healthier, more fulfilling life, this support is especially vital for those dealing with chronic illnesses. Such conditions pose a risk for psychological problems, potentially complicating treatment and prognosis. Presently, digital and technological platforms are integrating psychological interventions for patients with chronic diseases, showcasing an innovative approach to address psychological challenges.

The platform integrates new technologies for assessment and intervention. Ecological Momentary Assessment enables real-time evaluation, with data transferred to the technological platform. Artificial intelligence personalizes interventions based on participants' socio-demographic characteristics and assessment results. Ecological Momentary Intervention is employed for in-context treatments in participants' daily lives and natural environments. A serious game method, proven effective in various interventions, is used to engage adolescents and young people intrinsically. The game encompasses six main areas aligning with theoretical models, facilitating the development of socio-emotional competencies, and promoting physical and psychological health. It addresses different aspects of psychological and subjective well-being, reinforcing resources needed to navigate vital changes in these developmental stages, especially when living with a chronic illness.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Diabetes mellitus type 1 (6 months from diagnosis)
* Informed consent by parents/guardians and participants

Exclusion Criteria:

* Diagnosis other than type 1 diabetes mellitus
* No access to internet or new technologies
* Not speaking Spanish

Primary outcomes:
measure: Change Quality of Life (Baseline-Pre-Post)
timeFrame: Baseline up to 12 weeks
measure: Change Emotional and Behavioral Problems (Baseline-Pre-Post)
timeFrame: Baseline up to 12 weeks
measure: Change Emotional Competences (Baseline-Pre-Post)
timeFrame: Baseline up to 12 weeks
measure: Change Self-concept (Baseline-Pre-Post)
timeFrame: Baseline up to 12 weeks
measure: Change Coping (Baseline-Pre-Post)
timeFrame: Baseline up to 12 weeks
measure: Change Social Skills (Baseline-Pre-Post)
timeFrame: Baseline up to 12 weeks
Secondary outcomes:
measure: Change Threat of disease(Baseline-Pre-Post)
timeFrame: Baseline up to 12 weeks
measure: Change Psychoeducation Diabetes
timeFrame: Start of the game and during the game
measure: Change Resilience (Baseline-Pre-Post)
timeFrame: Baseline up to 12 weeks
Other outcomes:
measure: Glycaemic control (Baseline-Pre-Post)
timeFrame: Baseline up to 12 weeks
Locations:
city: Valencia
country: Spain
facility: Universitat de València
Study officials:
affiliation: University of Valencia
name: Marián Pérez-Marín, PhD
role: PRINCIPAL_INVESTIGATOR
References: