Clinical trial NCT05154292: SAEM: A Serious Game for Emotional Regulation Problems in Adolescents
Official title: A Serious Game for Psychological Assessment and Intervention in Adolescents With Emotional Regulation Problems
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adolescents
Keywords: Emotion Regulation
Adolescents
Serious Game
Anxiety
Behavior problems
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
Collaborators: name: Universitat Jaume I
name: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
First posted: 2021-12-13
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical Trial
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Difficulties in Emotional Regulation Scale (DERS; Hervás & Jódar, 2008)
timeFrame: Change from baseline at immediately after the intervention, and at 3 months
measure: Revised Child Anxiety and Depression Scale (RCADS-30; Pineda et al., 2018)
timeFrame: Change from baseline at immediately after the intervention, and at 3 months
Secondary outcomes:
measure: Avoidance and Fusion Questionnaire for Young People (AFQ-Y; Valdivia-Salas, Martín-Albo, Zaldívar, Lombas, & Jiménez, 2016)
timeFrame: Change from baseline at immediately after the intervention, and at 3 months
measure: . Willingness and Action Scale for Children and Adolescents (WAM; Cobos, Flujas-Contreras, & Gomez, 2020)
timeFrame: Change from baseline at immediately after the intervention, and at 3 months
measure: Mood and coping
timeFrame: Change from baseline at immediately after the intervention, and at 3 months
Other outcomes:
Locations:
city: Almeria
country: Spain
facility: Torrecardenas Hospital
state: Andalucia
city: Almería
country: Spain
facility: University of Almería
state: Andalucia
city: Castellón De La Plana
country: Spain
facility: University Jaume I
state: Castellón
Study officials:
affiliation: Universidad de Almeria
name: Inmaculada Gómez Becerra, Prof PhD
role: PRINCIPAL_INVESTIGATOR
References: