UnknownNot Applicable

SAEM: A Serious Game for Emotional Regulation Problems in Adolescents

Spain120 participantsStarted 2022-01-01

Plain-language 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.

Who can participate

Age range

12 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

Trial details

NCT IDNCT05154292

SponsorUniversidad de Almeria

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-30

Contact for this trial

Inmaculada Gómez-Becerra, Prof.

+34 950 214414 igomez@ual.es

View on ClinicalTrials.gov More Adolescents trials

Who can participate

Age range

12 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

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