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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05154292
Other study ID # UALPsy002
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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