SAEM: A Serious Game for Emotional Regulation Problems in Adolescents

Adolescents Clinical Trial

— SAEMGame  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05154292
• Other study ID #: UALPsy002
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2021
• Source: Universidad de Almeria
• Contact: Inmaculada Gómez-Becerra, Prof.
• Phone: +34 950 214414
• Email: igomez[@]ual.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescents

Intervention

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.

Locations

Country	Name	City	State
Spain	Torrecardenas Hospital	Almeria	Andalucia
Spain	University of Almería	Almería	Andalucia
Spain	University Jaume I	Castellón De La Plana	Castellón

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Almeria	Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental, Universitat Jaume I

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	. 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
Secondary	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