AdolescentsSAEMGameNCT05154292
SAEM: A Serious Game for Emotional Regulation Problems in Adolescents
A study testing Serious Game: Emotional Health Island (SAEM) in people with Adolescents, run by Universidad de Almeria at 3 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescents
- What is being tested?
- Serious Game: Emotional Health Island (SAEM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Jan 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Exhibit incapacitating neurological and/or intellectual impairment
- Have a diagnosis of severe mental disorder
- Substance abuse addiction or dependence
Trial locations and contacts
3 sites in 1 country.
Juan M Flujas-Contreras, PhD contact
Spain3 sites
Torrecardenas Hospital
Almería, Andalusia, 04009
University of Almería
Almería, Andalusia, 04120
University Jaume I
Castellon, Castellón, 12071
About this study
Official title: A Serious Game for Psychological Assessment and Intervention in Adolescents With Emotional Regulation Problems
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.
Read the 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.
- Conditions
- Adolescents
- Being tested
- Serious Game: Emotional Health Island (SAEM)
- Keywords
- Emotion Regulation, Adolescents, Serious Game, Anxiety, Behavior problems
- Medical subject headings
- Emotional Regulation, Anxiety Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious Game: Emotional Health Island (SAEM)Behavioural
Also called Isla de SAEM (Salud Emocional) (ES)
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.
| Study group | Role | What they receive |
|---|---|---|
| eHealth Emotion Regulation Skills | Experimental | The 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 Receives: Behavioral: Serious Game: Emotional Health Island (SAEM) |
| Waiting List | No intervention | He or she will not be exposed to the intervention but will remain on the waiting list and will complete the pre and post-measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 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)
) 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.
Measured: Change from baseline at immediately after the intervention, and at 3 months
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.
Measured: Change from baseline at immediately after the intervention, and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start1 Jan 2022 (estimated)
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdolescentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical Trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Jaume I, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
- Responsible party
- Principal investigator, Juan Miguel Flujas, Universidad de Almeria
- Investigators
- Inmaculada Gómez Becerra, Prof PhD, Principal investigator, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154292
- Sponsor's protocol ID
- UALPsy002
- Acronym
- SAEMGame
- Status last verified
- Nov 2021
- First submitted
- 29 Nov 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Serious Game for Psychological Assessment and Intervention in Adolescents With Emotional Regulation Problems
- ClinicalTrials.gov ID
- NCT05154292
- Acronym / sponsor ID
- SAEMGame / UALPsy002
- Conditions
- Adolescents
- Keywords
- Emotion Regulation, Adolescents, Serious Game, Anxiety, Behavior problems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Collaborators
- Universitat Jaume I, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| eHealth Emotion Regulation Skills | Experimental | Behavioral: Serious Game: Emotional Health Island (SAEM)The 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 intervention | –He or she will not be exposed to the intervention but will remain on the waiting list and will complete the pre and post-measures. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Exhibit incapacitating neurological and/or intellectual impairment
- Have a diagnosis of severe mental disorder
- Substance abuse addiction or dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serious Game: Emotional Health Island (SAEM)Also: Isla de SAEM (Salud Emocional) (ES)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. | Behavioural | eHealth Emotion Regulation Skills |
Primary outcome
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.
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.
3 secondary outcomes
Avoidance and Fusion Questionnaire for Young People (AFQ-Y; Valdivia-Salas, Martín-Albo, Zaldívar, Lombas, & Jiménez, 2016)
Time frame: 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)
Time frame: Change from baseline at immediately after the intervention, and at 3 months
Mood and coping
Time frame: Change from baseline at immediately after the intervention, and at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan M Flujas-Contreras, PhD contact
Inmaculada Gómez Becerra, Prof PhD principal investigator
Universidad de Almeria
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serious Game: Emotional Health Island (SAEM) in people with Adolescents, run by Universidad de Almeria at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inmaculada Gómez-Becerra, Prof. (+34 950 214414, igomez@ual.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Difficulties in Emotional Regulation Scale (DERS; Hervás & Jódar, 2008) (time frame: Change from baseline at immediately after the intervention, and at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.