SAEM: A Serious Game for Emotional Regulation Problems in Adolescents

Study Overview
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Brief Summary
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This study aims to assess the effects of an intervention to improve emotional regulation skills in adolescents with affective (anxiety and/or depression) and behavioral problems.

Detailed Description
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Emotional regulation skills and strategies are a protective factor against various problems and psychopathologies. The development and maintenance of affective symptoms are usually very harmful to the adolescent and for his/her family and social environment and can lead to other more serious psychological problems (depression, anxiety, adaptive disorders, etc.) or problems of socio-educational maladjustment. This study aims to improve the emotional regulation of adolescents who present affective symptoms related to anxiety, depression, or behavioral problems, such as difficulties in their interpersonal relationships, impulsivity, anxiety, anger attacks, low tolerance to frustration, apathy, or sadness. The intervention program, applied through a video game, is an intervention protocol for emotional well-being that has been tested and validated in an adolescent population with emotional and behavioral problems.

Official Title
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A Serious Game for Psychological Assessment and Intervention in Adolescents With Emotional Regulation Problems

Conditions
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Adolescents

Intervention / Treatment
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* Behavioral: Serious Game: Emotional Health Island (SAEM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 12 and 16 years old Show affective symptoms associated with depression and anxiety or behavior problems Show willingness to participate in the research study Understand written and spoken Spanish Show stability in treatment dosage, if taking medication. Exclusion Criteria: Exhibit incapacitating neurological and/or intellectual impairment Have a diagnosis of severe mental disorder Substance abuse addiction or dependence

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Clinical Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eHealth Emotion Regulation Skills<br>The intervention aims to develop competencies for emotional regulation through exposure and acceptance strategies for coping with circumstances that produce stress or emotional discomfort. The application has a series of mini-games that the user will overcome throughout a narrative, with different challenges and rewards | Behavioral: Serious Game: Emotional Health Island (SAEM)<br>* This intervention aims to aim to develop competencies for emotional regulation through exposure and acceptance strategies. This intervention is applied through a serious game developed for this purpose. the adolescent will complete a series of missions aimed at developing skills related to psychological flexibility, namely, greater psychological acceptance, mindfulness in the present moment, and committed actions in the direction of personal values. This serious game is guided by a therapist.<br>* Other names: Isla de SAEM (Salud Emocional) (ES);|
| No Intervention: Waiting List<br>He or she will not be exposed to the intervention but will remain on the waiting list and will complete the pre and post-measures. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Difficulties in Emotional Regulation Scale (DERS; Hervás & Jódar, 2008) | Consists of 28 items that make up 6 dimensions of emotional dysregulation: attention, acceptance, impulsivity, clarity, goals and strategies. The reliability index is between .87 and .93. | Change from baseline at immediately after the intervention, and at 3 months | 
| Revised Child Anxiety and Depression Scale (RCADS-30; Pineda et al., 2018) | it is a 30-item scale to assess the presence of symptoms associated or compatible with depression and anxiety in children and adolescents. Internal consistency between .78 and .93. | Change from baseline at immediately after the intervention, and at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Avoidance and Fusion Questionnaire for Young People (AFQ-Y; Valdivia-Salas, Martín-Albo, Zaldívar, Lombas, & Jiménez, 2016) | that assesses the level of avoidance and cognitive fusion present when faced with distressing situations. This scale presents a Cronbach's alpha between .76 and 87. | Change from baseline at immediately after the intervention, and at 3 months | 
| . Willingness and Action Scale for Children and Adolescents (WAM; Cobos, Flujas-Contreras, & Gomez, 2020) | ) to assess levels of acceptance and behavioral activation (action) in the direction of valued life areas. This scale shows an internal consistency between .76 and .81. | Change from baseline at immediately after the intervention, and at 3 months | 
| Mood and coping | At the start and close of the App, a series of questions will appear that measure mood of the users by means of a visual face scale (5-point Likert) and a coping question by means of a 5-point Likert scale. | Change from baseline at immediately after the intervention, and at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emotion Regulation, Adolescents, Serious Game, Anxiety, Behavior problems