Substance Use DisorderNCT06737744
Active Games for Increasing Social and Emotional Competencies of Young Adults in Probation System: a One-Sample Trial Study in Izmir City in Turkiye
A study testing Active Games for Change (AG4C) and Active Games for Change Group Working in people with Substance Use Disorder and Sports, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The goal of this one-sample clinical trial is to implement active games, including physical activities, that support the social and emotional competencies of individuals in probation sentence. Methods: The study was carried out with 50 young adult offenders. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Substance Use Disorder, Sports, Competency Based Education
- What is being tested?
- Active Games for Change (AG4C) and Active Games for Change Group Working
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jan 2021to 9 Feb 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- being between 18 and 30 years old
- having any kind of criminal background under probation supervision
- having at least four months left on their probation sentence.
Who cannot join
- having physical health issues
- severe mental disorders such as schizophrenia, borderline personality disorder, and antisocial personality disorder.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Institute on Drug Abuse, Toxicology and Pharmaceutical Science
Izmir, 35100
About this study
Objective: The goal of this one-sample clinical trial is to implement active games, including physical activities, that support the social and emotional competencies of individuals in probation sentence.
Methods: The study was carried out with 50 young adult offenders. The Collaborative for Academic, Social, and Emotional Learning (CASEL) model, which defines five social and emotional skills (self-awareness, self-management, responsible decision making, relationship skills, social awareness), was used to support observation and game design. The present study involved the codesign of a total of 18 active games to develop these five competencies. The primary outcomes of the research were increased mental well-being and increased social emotional skills in participants receiving the AG4C program. The secondary outcome of the research was the regular participation of the participants in the program. In this study, two hypotheses were tested: "The ActiveGames4Change programme increases the psychological wellbeing of young adults on probation" and "The ActiveGames4Change programme increases the 5 basic skills of young adults on probation. This study was carried out with 50 young adult offender individuals (48 male and 2 female) who received probation measures in accordance with the court or prosecutor's decision for different crimes. The CASEL model, which defines social and emotional skills, was used to support observation and game design because it determines the characteristics of young people who are in the execution process. The skill set proposed by the CASEL model included skills such as "self-awareness", "self-management", "social awareness", "relationship skills" and "responsible decision-making".
The Wilcoxon signed-rank test was employed to examine the impact of the intervention on participants' progression of competency levels before and after the intervention.
Read the detailed description
This work involved the codesign of 18 active games to develop five core competencies. Each game was designed with three levels: Level 1 games require less complex social and emotional competencies; Level 2 acts as a bridge to cement and develop those established in Level 1; and Level 3 requires either more competencies or competencies used at a higher level of difficulty. Nine of them were applied to 38 participants during 4 sessions at different times in the present study between 14/12/2021 and 09/02/2022.
Nine of the 18 games could not be played due to the limitations of the COVID-19 pandemic. It was carried out by 10 trainers with 50 (including 12 dropouts) young individuals at the Izmir Probation Directorate in Turkiye. Since the current physical conditions of the institution were not suitable, a full-fledged sports hall affiliated with the municipality was implemented as a result of cooperation with a local governmental institution. The Turkish version of the Warwick-Edinburgh Well-being Scale (WEMWBS) was used by the participants before and at the end of the AG4C Program, which evaluated the five SECs mentioned above. All measurements were obtained by asking the participant by the instructor/educator or researcher instead of self-reporting.
Thus, the biases caused by the participants were minimized by ensuring that the participants perceived the questions correctly.
Eighteen games were designed within the CASEL framework, and each game had three levels, which means that there were six games at each level. The game cards were developed, which included instructions about how to implement the game for educators and learners (probationers). All games were also available on the specially designed AG4C App (www.activegames4change.org/ag4c-app.html), where progress data could also be captured.
After the games were designed, 10 educators in a probation service were trained by two master trainers to enable them to test the games program with young people as well as to gather both pre- and post-intervention data. Additionally, the educators (n=10) conducted evaluations of the games that they had implemented for the participants.
A comprehensive training package was provided to the educators of the Izmir Probation Directorate. The package consisted of 18 games and online theoretical and practical training with video tutorials. The games were collaboratively developed in English by experts through expert panels and 2 validation workshops, all of which involved AG4C project partners, before they were adapted for usage. Subsequently, the researcher translated all the materials from English into Turkish in preparation for use in the pilot program in Turkiye.
- Conditions
- Substance Use Disorder, Sports, Competency Based Education, Psychological Well Being, Addiction
- Being tested
- Active Games for Change (AG4C), Active Games for Change Group Working
- Keywords
- substance use disorder, physical activity, youth justice, probation service, education, mental health well being, addiction
- Medical subject headings
- Substance-Related Disorders, Psychological Well-Being, Behavior, Addictive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Games for Change (AG4C)Other
This intervention was carried out in Turkiye within the Erasmus+ Key Action 3 project titled Active Games for Change (AG4C). The programme included a series of innovative, face-to-face active games with a non-formal approach that prioritised physical activity, specifically designed to support the development of social and emotional competencies identified for the first time in the field in a probation directorate serving young adult offenders.
Active Games for Change Group WorkingBehavioural
Also called "Active Games for Change, AG4C
The Active Games for Change intervention program was implemented in Izmir, Türkiye within the Erasmus+ Key Action 3 project titled Active Games for Change (AG4C). The AG4C intervention program included a series of innovative, face-to-face active games with a non-formal approach that prioritised support for developing social and emotional competencies of young adults with substance use problems, for the first time in the field.
| Study group | Role | What they receive |
|---|---|---|
| AG4C intervention group | Experimental | Not described Receives: Other: Active Games for Change (AG4C); Behavioral: Active Games for Change Group Working |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total score of the mental well-being
The total score for mental well-being was obtained from the Warwick Edinburgh Mental Well-being Scale (WEMWBS) in Turkish, completed by participants verbally with the assistance of educators, before and at the end of the "Active Games 4 Change" intervention. WEMWBS was developed and validated for multicultural use and is available in Turkish. The scale consists of 14 positive items and has a 5-point Likert-type answer key. The lowest score is 14 points and the highest score is 70 points. High scores obtained from the scale indicate high mental (psychological) well-being. The Turkish version of WEMWBS retains the single-factor structure of the original scale and demonstrates robust validity and reliability. The queries were cross-referenced with CASEL's core social-emotional competencies to ensure each was covered by at least one question.
Measured: From enrollment to the end of intervention at 8 weeks
Social Emotional Skills
Collaborative for Academic, Social and Emotional Learning(CASEL) defines 5 social emotional skills:Self-Awareness(SA1), Social Awareness(SA2), Self-Management(SM) Relationship skills(R) and Responsible Decision-making(RD) which guided the design of 18 games to develop these skills.To observe the five CASEL social emotional skills of the participants,Warwick-Edinburgh Well-being Scale (WEMWBS) items were evaluated, and the team of this research determined which items best described each skill.The queries WEMWBS were cross-referenced with CASEL's skills to ensure each was covered by at least one item in WEMWBS.A matching process aligned CASEL skills with WEMWBS scoring,generating sub-scores to assess each skill's progress.Higher scores indicated greater progress.The matched items with points:SA1-items 2,3,8,10(min:4,max:20);SA2-item 4(min:1,max:5);SM-items 1,5,13(min:3,max:15);R-items 9,12(min:2,max:10);RD-items 6,7,11(min:3,max:15).Each response was scored on a scale of 1 to 5 points.
Measured: From enrollment to the end of intervention at 8 weeks
Secondary outcomes (1)
Regular participation of the participants in the program
Regular participation is defined as attending at least 2 out of 4 sessions during the 8-week intervention. Participation rates were recorded by educators using a participant registration form which was created by the researcher team.
Unit of Measure: Percentage of participants meeting the attendance criteria (%).
Measured: From enrollment to the end of intervention at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start14 Jan 2021
- Primary completion9 Feb 2022
- Study completion9 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisorderStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The recruitment of this study was conducted in accordance with a pre-established plan, which entailed the selection of a total of 50 participants who met the established inclusion and exclusion criteria. These participants were divided into groups of 7-10 individuals. Each participant was required to attend a minimum of 2 and a maximum of 4 different sessions. In each session, the participants were exposed to games with varying levels of difficulty and content, which were designed to develop the specified competencies and skills outlined in the CASEL model at different levels. The majority of these games were group games that involved low or moderate physical activity.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Principal investigator, Inci Derya YUCEL, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737744
- Sponsor's protocol ID
- REC.20.16.1
- Other IDs
- 604730EPP120181UKEPPKA3IPISOC-
- Status last verified
- Dec 2024
- First submitted
- 28 Nov 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wigelsworth M. SPECTRUM': Social, psychological, emotional, concepts of self, and resilience: Understanding and measurement. 2017
Keldal G. Warwick-Edinburgh Turkish Version of the Warwick-Edinburgh Mental Well-Being Scale: A validity and reliability study. The Journal of Happiness & Well-Being. 2015; 3(1), 103-115.
World Health Organization. WHO guidelines on physical activity and sedentary behaviour. Online from https://apps.who.int/iris/bitstream/handle/10665/336656/9789240015128-eng.pdf?sequence=1&isAllowed=y - retrieved 18.05.2023. 2020.
Moyles, J. EBOOK: The Excellence of Play. McGraw-Hill Education (UK). 2014
Yucel ID, Yararbas G. Active games for increasing social and emotional competencies of young adults in probation system: a one-sample trial study in Izmir city in Turkiye. BMC Psychol. 2024 Dec 31;12(1):797. doi: 10.1186/s40359-024-02309-0.
PubMed 39741356
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Games for Increasing Social and Emotional Competencies of Young Adults in Probation System: a One-Sample Trial Study in Izmir City in Turkiye
- ClinicalTrials.gov ID
- NCT06737744
- Acronym / sponsor ID
- REC.20.16.1
- Conditions
- Substance Use Disorder, Sports, Competency Based Education, Psychological Well Being, Addiction
- Keywords
- substance use disorder, physical activity, youth justice, probation service, education, mental health well being, addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 17 Dec 2024 (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.
Objective: The goal of this one-sample clinical trial is to implement active games, including physical activities, that support the social and emotional competencies of individuals in probation sentence.
Methods: The study was carried out with 50 young adult offenders. The Collaborative for Academic, Social, and Emotional Learning (CASEL) model, which defines five social and emotional skills (self-awareness, self-management, responsible decision making, relationship skills, social awareness), was used to support observation and game design. The present study involved the codesign of a total of 18 active games to develop these five competencies. The primary outcomes of the research were increased mental well-being and increased social emotional skills in participants receiving the AG4C program. The secondary outcome of the research was the regular participation of the participants in the program. In this study, two hypotheses were tested: "The ActiveGames4Change programme increases the psychological wellbeing of young adults on probation" and "The ActiveGames4Change programme increases the 5 basic skills of young adults on probation. This study was carried out with 50 young adult offender individuals (48 male and 2 female) who received probation measures in accordance with the court or prosecutor's decision for different crimes. The CASEL model, which defines social and emotional skills, was used to support observation and game design because it determines the characteristics of young people who are in the execution process. The skill set proposed by the CASEL model included skills such as "self-awareness", "self-management", "social awareness", "relationship skills" and "responsible decision-making".
The Wilcoxon signed-rank test was employed to examine the impact of the intervention on participants' progression of competency levels before and after the intervention.
Detailed description
This work involved the codesign of 18 active games to develop five core competencies. Each game was designed with three levels: Level 1 games require less complex social and emotional competencies; Level 2 acts as a bridge to cement and develop those established in Level 1; and Level 3 requires either more competencies or competencies used at a higher level of difficulty. Nine of them were applied to 38 participants during 4 sessions at different times in the present study between 14/12/2021 and 09/02/2022.
Nine of the 18 games could not be played due to the limitations of the COVID-19 pandemic. It was carried out by 10 trainers with 50 (including 12 dropouts) young individuals at the Izmir Probation Directorate in Turkiye. Since the current physical conditions of the institution were not suitable, a full-fledged sports hall affiliated with the municipality was implemented as a result of cooperation with a local governmental institution. The Turkish version of the Warwick-Edinburgh Well-being Scale (WEMWBS) was used by the participants before and at the end of the AG4C Program, which evaluated the five SECs mentioned above. All measurements were obtained by asking the participant by the instructor/educator or researcher instead of self-reporting.
Thus, the biases caused by the participants were minimized by ensuring that the participants perceived the questions correctly.
Eighteen games were designed within the CASEL framework, and each game had three levels, which means that there were six games at each level. The game cards were developed, which included instructions about how to implement the game for educators and learners (probationers). All games were also available on the specially designed AG4C App (www.activegames4change.org/ag4c-app.html), where progress data could also be captured.
After the games were designed, 10 educators in a probation service were trained by two master trainers to enable them to test the games program with young people as well as to gather both pre- and post-intervention data. Additionally, the educators (n=10) conducted evaluations of the games that they had implemented for the participants.
A comprehensive training package was provided to the educators of the Izmir Probation Directorate. The package consisted of 18 games and online theoretical and practical training with video tutorials. The games were collaboratively developed in English by experts through expert panels and 2 validation workshops, all of which involved AG4C project partners, before they were adapted for usage. Subsequently, the researcher translated all the materials from English into Turkish in preparation for use in the pilot program in Turkiye.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The recruitment of this study was conducted in accordance with a pre-established plan, which entailed the selection of a total of 50 participants who met the established inclusion and exclusion criteria. These participants were divided into groups of 7-10 individuals. Each participant was required to attend a minimum of 2 and a maximum of 4 different sessions. In each session, the participants were exposed to games with varying levels of difficulty and content, which were designed to develop the specified competencies and skills outlined in the CASEL model at different levels. The majority of these games were group games that involved low or moderate physical activity.
| Arm | Type | Receives |
|---|---|---|
| AG4C intervention group | Experimental | Other: Active Games for Change (AG4C), Behavioral: Active Games for Change Group Working |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- being between 18 and 30 years old
- having any kind of criminal background under probation supervision
- having at least four months left on their probation sentence.
Key exclusion criteria (2 listed)
- having physical health issues
- severe mental disorders such as schizophrenia, borderline personality disorder, and antisocial personality disorder.
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 |
|---|---|---|
| Active Games for Change (AG4C)This intervention was carried out in Turkiye within the Erasmus+ Key Action 3 project titled Active Games for Change (AG4C). The programme included a series of innovative, face-to-face active games with a non-formal approach that prioritised physical activity, specifically designed to support the development of social and emotional competencies identified for the first time in the field in a probation directorate serving young adult offenders. | Other | AG4C intervention group |
| Active Games for Change Group WorkingAlso: "Active Games for Change, AG4CThe Active Games for Change intervention program was implemented in Izmir, Türkiye within the Erasmus+ Key Action 3 project titled Active Games for Change (AG4C). The AG4C intervention program included a series of innovative, face-to-face active games with a non-formal approach that prioritised support for developing social and emotional competencies of young adults with substance use problems, for the first time in the field. | Behavioural | AG4C intervention group |
Primary outcome
The total score of the mental well-being
Time frame: From enrollment to the end of intervention at 8 weeks
The total score for mental well-being was obtained from the Warwick Edinburgh Mental Well-being Scale (WEMWBS) in Turkish, completed by participants verbally with the assistance of educators, before and at the end of the "Active Games 4 Change" intervention. WEMWBS was developed and validated for multicultural use and is available in Turkish. The scale consists of 14 positive items and has a 5-point Likert-type answer key. The lowest score is 14 points and the highest score is 70 points. High scores obtained from the scale indicate high mental (psychological) well-being. The Turkish version of WEMWBS retains the single-factor structure of the original scale and demonstrates robust validity and reliability. The queries were cross-referenced with CASEL's core social-emotional competencies to ensure each was covered by at least one question.
Social Emotional Skills
Time frame: From enrollment to the end of intervention at 8 weeks
Collaborative for Academic, Social and Emotional Learning(CASEL) defines 5 social emotional skills:Self-Awareness(SA1), Social Awareness(SA2), Self-Management(SM) Relationship skills(R) and Responsible Decision-making(RD) which guided the design of 18 games to develop these skills.To observe the five CASEL social emotional skills of the participants,Warwick-Edinburgh Well-being Scale (WEMWBS) items were evaluated, and the team of this research determined which items best described each skill.The queries WEMWBS were cross-referenced with CASEL's skills to ensure each was covered by at least one item in WEMWBS.A matching process aligned CASEL skills with WEMWBS scoring,generating sub-scores to assess each skill's progress.Higher scores indicated greater progress.The matched items with points:SA1-items 2,3,8,10(min:4,max:20);SA2-item 4(min:1,max:5);SM-items 1,5,13(min:3,max:15);R-items 9,12(min:2,max:10);RD-items 6,7,11(min:3,max:15).Each response was scored on a scale of 1 to 5 points.
1 secondary outcome
Regular participation of the participants in the program
Time frame: From enrollment to the end of intervention at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- BackgroundWigelsworth M. SPECTRUM': Social, psychological, emotional, concepts of self, and resilience: Understanding and measurement. 2017
- BackgroundKeldal G. Warwick-Edinburgh Turkish Version of the Warwick-Edinburgh Mental Well-Being Scale: A validity and reliability study. The Journal of Happiness & Well-Being. 2015; 3(1), 103-115.
- BackgroundWorld Health Organization. WHO guidelines on physical activity and sedentary behaviour. Online from https://apps.who.int/iris/bitstream/handle/10665/336656/9789240015128-eng.pdf?sequence=1&isAllowed=y - retrieved 18.05.2023. 2020.
- BackgroundMoyles, J. EBOOK: The Excellence of Play. McGraw-Hill Education (UK). 2014
- Derived from this study: PubMed 39741356Yucel ID, Yararbas G. Active games for increasing social and emotional competencies of young adults in probation system: a one-sample trial study in Izmir city in Turkiye. BMC Psychol. 2024 Dec 31;12(1):797. doi: 10.1186/s40359-024-02309-0.
- Leading Change Through Activity \& Sports - A Handbook for Leaders about the AG4C MethodologyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Games for Change (AG4C) and Active Games for Change Group Working in people with Substance Use Disorder and Sports, run by Ege University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total score of the mental well-being (time frame: From enrollment to the end of intervention at 8 weeks). 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?
On the ClinicalTrials.gov record for NCT06737744, which also lists 5 linked publications.
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 17 Dec 2024.