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
1 other identifier
interventional
120
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2021
CompletedFirst Posted
Study publicly available on registry
December 13, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedDecember 13, 2021
November 1, 2021
7 months
November 29, 2021
November 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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 Arms (2)
eHealth Emotion Regulation Skills
EXPERIMENTALThe 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
Waiting List
NO INTERVENTIONHe or she will not be exposed to the intervention but will remain on the waiting list and will complete the pre and post-measures.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Exhibit incapacitating neurological and/or intellectual impairment
- Have a diagnosis of severe mental disorder
- Substance abuse addiction or dependence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Torrecardenas Hospital
Almería, Andalusia, 04009, Spain
University of Almería
Almería, Andalusia, 04120, Spain
University Jaume I
Castellon, Castellón, 12071, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Inmaculada Gómez Becerra, Prof PhD
Universidad de Almeria
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
November 29, 2021
First Posted
December 13, 2021
Study Start
January 1, 2022
Primary Completion
July 30, 2022
Study Completion
December 30, 2022
Last Updated
December 13, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- At the end of the RCT. For a period of 1 year.
- Access Criteria
- Open access in data repository or under request to authors.
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.