Emoticare: Serious Game for the Adaptation to the Disease of Adolescents with Type 1 Diabetes Mellitus.

University of Valencia

Status: Invitation-only

Conditions: Adolescent Development; Type 1 Diabetes

Treatments: Behavioral: EmoTiCare

Study type: Interventional

Funder types: Other

Identifiers

NCT06331429

EmoTiCare

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 12 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Control Group

No Intervention group

Description:

Patients who receive the treatment program, will previously constitute their own control group (waiting list control group).

Experimental group

Experimental group

Description:

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 6 weeks of this assessment the treatment program will be started. In the first contact session at 6 weeks after T1 all adolescents will be re-assessed (T2) and after this the treatment program will be started (within an estimated time of 15 days maximum from this second pre-treatment evaluation, the estimated duration of treatment being 6 weeks). After the completion of the serious game, a new asssesment pass will be performed (T3) in order to assess the post-treatment change. Thus, the estimated time between T2 and T3 will be equivalent to that between T1 and T2, being 6 weeks.

Treatment:

Behavioral: EmoTiCare