SAEM: A Serious Game for Emotional Regulation Problems in Adolescents (SAEMGame)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Adolescents
• Intervention / Treatment: Behavioral: Serious Game: Emotional Health Island (SAEM)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Inmaculada Gómez-Becerra, Prof.; Phone Number: +34 950 214414; Email: igomez@ual.es
• Study Contact Backup: Name: Juan M Flujas-Contreras, PhD; Email: jm.flujas@ual.es

Study Locations

• Spain
  • Andalucia
    • Almeria, Andalucia, Spain, 04009
      • Torrecárdenas Hospital
    • Almería, Andalucia, Spain, 04120
      • University of Almeria
  • Castellón
    • Castellón De La Plana, Castellón, Spain, 12071
      • University Jaume I

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eHealth Emotion Regulation Skills; 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); 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.; Other Names: Isla de SAEM (Salud Emocional) (ES)
No Intervention: Waiting List; 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?

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

Collaborators and Investigators

• Sponsor: Universidad de Almeria
• Collaborators: Universitat Jaume I; Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
• Investigators: Principal Investigator: Inmaculada Gómez Becerra, Prof PhD, Universidad de Almeria

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Actual): December 13, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Adolescents; Anxiety; Emotion Regulation; Behavior problems; Serious Game
• Other Study ID Numbers: UALPsy002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data will be published in a data repository and in the publications that are necessary. The data related to the responses will be published in the self-reported evaluation systems, mainly, pre, post and follow-up that have an impact on the evaluation of the effectiveness of the treatment.
• IPD Sharing Time Frame: At the end of the RCT. For a period of 1 year.
• IPD Sharing Access Criteria: Open access in data repository or under request to authors.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

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