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Clinical Trials/NCT05154292
NCT05154292
Unknown
Not Applicable

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

Universidad de Almeria3 sites in 1 country120 target enrollmentJanuary 1, 2022
ConditionsAdolescents

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adolescents
Sponsor
Universidad de Almeria
Enrollment
120
Locations
3
Primary Endpoint
Revised Child Anxiety and Depression Scale (RCADS-30; Pineda et al., 2018)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
December 30, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Juan Miguel Flujas

PhD

Universidad de Almeria

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

Outcomes

Primary Outcomes

Revised Child Anxiety and Depression Scale (RCADS-30; Pineda et al., 2018)

Time Frame: Change from baseline at immediately after the intervention, and at 3 months

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.

The Difficulties in Emotional Regulation Scale (DERS; Hervás & Jódar, 2008)

Time Frame: Change from baseline at immediately after the intervention, and at 3 months

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.

Secondary Outcomes

  • Avoidance and Fusion Questionnaire for Young People (AFQ-Y; Valdivia-Salas, Martín-Albo, Zaldívar, Lombas, & Jiménez, 2016)(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)(Change from baseline at immediately after the intervention, and at 3 months)
  • Mood and coping(Change from baseline at immediately after the intervention, and at 3 months)

Study Sites (3)

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