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

Smart Technology Platform for Socio-emotional Development and Health Promotion: Implementation and Validation of a Serious Game in Adolescentes With DM1

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 1 Diabetes; Adolescent Development
• Intervention / Treatment: Behavioral: EmoTiCare

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marián Pérez-Marín, PhD; Phone Number: 83392 0034 9639; Email: marian.perez@uv.es

Study Locations

• Spain
  • Valencia, Spain
    • Universitat de Valencia
    • Contact: Marián Pérez-Marín, PhD; Phone Number: 963983392; Email: marian.perez@uv.es
    • Sub-Investigator: Inmaculada Montoya-Castilla, PhD
    • Sub-Investigator: Selene Valero Moreno, PhD
    • Sub-Investigator: Javier Martín Ávila, MsC
    • Sub-Investigator: Esther Rodríguez-Jiménez, MsC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Patients who receive the treatment program, will previously constitute their own control group (waiting list control group).
Experimental: 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 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.	Behavioral: EmoTiCare; The EMOTICARE 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 works in 6 areas, each of which refers to one of the variables that are analysed or considered important in the adaptation to the disease: Area 1. Psychoeducation of DM1; 2. Emotional awareness and expression; 3. Emotional regulation; 4. Problem solving; 5. Self-esteem and identity;6. Social skills and communication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 6 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.	Baseline up to 12 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 behavioural 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 behaviour. 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 6 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.	Baseline up to 12 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 6 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.	Baseline up to 12 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 6 weeks after the first measurement of the same variable. The third measurement, labeled POST, was carried out up to 6 weeks after the second measurement.	Baseline up to 12 weeks
Change Coping (Baseline-Pre-Post)	Social Problem Solving Inventory- Revised (SPSI-R). This questionnaire attempts to reflect the cognitive, affective and behavioural 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 6 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.	Baseline up to 12 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 6 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.	Baseline up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change 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 6 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.	Baseline up to 12 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.	Start of the game and during the game
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 6 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.	Baseline up to 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycaemic control (Baseline-Pre-Post)	HbA1c: It will be used to evaluate the glycemic control of the diabetic patient in endocrinology diseases	Baseline up to 12 weeks

Collaborators and Investigators

• Sponsor: University of Valencia
• Collaborators: Universitat Politècnica de València
• Investigators: Principal Investigator: Marián Pérez-Marín, PhD, University of Valencia

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Type 1 Diabetes; Adolescence; Psychological intervention; Serious Game; Technology platform
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: EmoTiCare

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No