Specific Learning DisorderSENNCT06112483
SWELE Program: An Unstructured Outdoor Play With Mindfulness-based Interventions to Promote Mental Health Among Students With Special Education Needs
An observational study of Specific Learning Disorder and Intellectual Disability, Mild to Moderate, run by Chinese University of Hong Kong.
Trial summary
This is an observational study with the aim of SWELE Programme is to raise mental health knowledge and awareness by implementing a play-based approach on Supporting Wellness in E-Child Learning Environments (SWELE) programme combining unstructured outdoor play activities with mindfulness-based interventions to promote… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Specific Learning Disorder, Intellectual Disability, Mild to Moderate, Autism Spectrum Disorder
- What is being tested?
- SWELE Programme
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,064 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2023to 14 Jul 2024
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents aged 6-18 years old with mild to moderate physical and intellectual disabilities (SEN students) from six selected special schools. They will be recruited and participated the SWELE Programme.
Who may be able to join
- SEN students:
- are studying in a special school;
- can speak and understand Cantonese
- have no diagnosis of any cardiovascular disease
- can provide parental consent
Who cannot join
- SEN students:
- are not studying in a special school;
- do not speak and understand Cantonese
- have been diagnosed with cardiovascular disease
- do not provide parental consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: SWELE Programme: An Unstructured Outdoor Play With Mindfulness-based Interventions to Promote Mental Health Among Children and Adolescents With Special Education Needs
This is an observational study with the aim of SWELE Programme is to raise mental health knowledge and awareness by implementing a play-based approach on Supporting Wellness in E-Child Learning Environments (SWELE) programme combining unstructured outdoor play activities with mindfulness-based interventions to promote mental health in children and adolescents with special education needs (SEN), in the context of the COVID-19 pandemic.
This is a 16-week SWELE programme and it will be conducted in two batches. Each batch has three special schools. The main activities include: One training workshop for three groups in each special school: 1) Scout Leaders (special schools' teachers), 2) SEN students (scouts in the school) to become Youth Mental Health Ambassadors and 3) for parents, school social workers, school nurses, schoolteachers and stakeholders; 30 minutes unstructured outdoor play with mindfulness activities 2 times per week for 16 weeks
Read more
After participated the SWELE programme, the primary outcomes include reducing anxiety symptoms, reducing negative emotions, improving social skills in peer relationships; and changing in playfulness level among SEN children and adolescents.
Main activities of SWELE programme:
- Unstructured outdoor free play integrated into the school's extra-curricular activities (Youth Mental Health Ambassadors) to promote SEN students' mental health for objectives 1-4.
- Use mindfulness-based podcasts, mindfulness games, mindfulness art for objectives 1-2.
- Through meditation and deep breathing technique, storytelling with relaxing waves piano music, yoga and mindful art for objectives 1-2.
- Training Workshops (Training of trainers) for Scout Leaders who will implement SWELE program in each special school.
- Youth Mental Health Ambassador Program for SEN students who are enrolled in Scout Club in each special school; SWELE training workshops for parents and schoolteachers will also be held in each special school for objectives 1-4.
- Examples of unstructured play might be creative play alone or with others, including artistic or musical games. imaginative games - for example, making cubbyhouses with boxes or blankets, dressing up or playing make-believe, exploring new or favorite spaces like school backyards, parks, playgrounds and so on.
Read the detailed description
Intervention: SWELE Program:
How does this SWELE programme combine unstructured outdoor play with mindfulness-based interventions is different from other existing services in the community? This 16-week programme focuses on Supporting Wellness in E-Child Learning Environments (SWELE) programme by combining unstructured outdoor play with mindfulness-based interventions to promote mental health in SEN students, in the context of the COVID-19 pandemic. There is no such SWELE programme to promote mental health for SEN students in Hong Kong, especially in the context of COVID-19 pandemic. Six special schools have been recruited and they would participate the SWELE programme.
A playful approach of unstructured play has also been found effective on promoting positive emotions and emotional competence among early adolescents. Unstructured Outdoor Play coupled with Mindfulness-based Interventions via SWELE programme to Promote Mental Health for children and adolescents with SEN during COVID-19 pandemic. Very limited unstructured outdoor play-based programme integrated into the extra-curricular activities in the special schools in Hong Kong.
The COVID-19 pandemic has resulted in increased anxiety and stress among children and adolescents in Hong Kong. In order to help alleviate these symptoms, the project team of the SWELE program is collaborating with The Scout Association of Hong Kong on a 16-week SWELE programme to promote SEN students' mental health. The mindfulness-based interventions focus on social-emotional learning activities in schools. Without intentional social-emotional development, SEN students may not learn how to process their emotions and connect with other in healthy ways. That is where mindfulness can come in. What is mindfulness? Mindfulness involves both an awareness and an acceptance of both the world around us and our internal experiences. Mindful people tend to focus more on the present instead of reflecting on the past or future, and they cultivate a curiosity towards their thoughts, emotions, or physical sensations.
The new knowledge generates from the findings of this mental health promotion project are important for raising the public's awareness about the impact on SEN student's mental health and advancing our understanding of the COVID-19 pandemic's impacts on service disruption and transition and subsequently on concerning SEN students' mental health. Thus, school health policy and strategies should be developed appropriately in promoting SEN
- Conditions
- Specific Learning Disorder, Intellectual Disability, Mild to Moderate, Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Physical Disability
- Being tested
- SWELE Programme
- Keywords
- Unstructured play, Mindfulness-based interventions, Special education needs, Children and adolescents, Emotional, Anxiety, Depression, Self-regulation
- Medical subject headings
- Specific Learning Disorder, Intellectual Disability, Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Anxiety Disorders, Depression, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWELE ProgrammeBehavioural
Also called Unstructured play with mindfulness-based interventions
This 16-week programme focuses on Supporting Wellness in E-Child Learning Environments (SWELE) programme by combining unstructured outdoor play with mindfulness-based interventions to promote mental health in SEN students, in the context of the COVID-19 pandemic. There is no such SWELE programme to promote mental health for SEN students in Hong Kong, especially in the context of COVID-19 pandemic.
A playful approach of unstructured play has also been found effective on promoting positive emotions and emotional competence among early adolescents (Harn \& Bo, 2019). Unstructured Outdoor Play coupled with Mindfulness-based Interventions via SWELE programme to Promote Mental Health for children and adolescents with SEN during COVID-19 pandemic. Very limited unstructured outdoor play-based programme integrated into the extra-curricular activities in the special schools in Hong Kong.
| Study group | Role | What they receive |
|---|---|---|
| Children and adolescents with special education needs | Children and adolescents with special education needs, including (a) specific learning difficulties; (b) intellectual disability; (c) autism; (d) attention deficit hyperactivity disorder; (e) physical disabilities. Receives: Behavioral: SWELE Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores from baseline to 16 weeks in SEN students' mood using the Mood Scale
To reduce over 80% of SEN students' low mood after participated the 16-week SWELE programme.
The Mood Scale includes five different emoji with a 5-points response scale of mood ranging from 1-5: 1-Very bad; 2-bad, 3-so-so, 4-good; to 5-very good. The range of scale score can be from 1 to 5 where higher scores represented very good mood and emotion.
Measured: 16 weeks
Change scores from baseline to 16 weeks in SEN students' anxiety symptoms using the Chinese version of the short-form State-Trait Anxiety Inventory (STAI-S-6 & STAI-T-7)
To reduce over 80% of SEN students' anxiety symptoms after participated the 16-week SWELE programme.
The Chinese version of short-form of State-Trait Anxiety Inventory (STAI-S-6 \& STAI-T-7) demonstrates sound psychometric properties to evaluate the anxiety level. Observers will be asked to rate each item using the following scale (Scale of 1-4; 1 = not at all, 2 = a little, 3 = moderate, 4 = extremely). The range of score from 13 to 52. The mean of the Inventory will be calculated and the mean difference will be compared between the baseline and at 16 weeks. The higher score shows a higher level of anxiety.
Measured: 16 weeks
Change scores from baseline to 16 weeks in SEN students' behavior regulations (classroom self-regulation and social skills) using the Child Behavior Rating Scale (CBRS)
To increase over 70% of SEN Students' self-regulation and social skills after participated the 16-week SWELE programme.
The Child Behavior Rating Scale (CBRS) consists of 17 items that measure children's behavioral regulation as illustrated by two subscales: the Classroom Self-Regulation subscale (10 items) and Social Skills subscale (7 items) that assess teachers' perceptions of children's behavioral regulation in social situations.
Observers/teachers will be asked to rate each item using the following scale (Scale of 1-5; 1 = not at all, 2 = a little, 3 = sometimes, 4= always, 5 = often). The range of score from 17 to 85. Scores The mean of the scale will be calculated with the mean difference will be compared between the baseline and at 16 weeks. The higher score shows a high anxiety level of individual.
Measured: 16 weeks
Change scores from baseline to 16 weeks in SEN students' playfulness using the Children's Playfulness Scale (CPS)
To increase 70% of SEN students' playfulness after participated the 16-week SWELE programme.
Children's Playfulness Scale (CPS) is a 23-item, and it was used by teachers evaluate the children's behavior. This 5-point Likert scale is designed to assess children's playfulness based on five dimensions: physical spontaneity, social spontaneity, cognitive spontaneity, manifest joy, and sense of humor. Each item poses a statement such as "the child uses unconventional objects in play," which is scored on a 5-point Likert-type scale with responses ranging from "sounds exactly like the child" to "doesn't sound at all like the child".
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start15 Nov 2023 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion14 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Specific Learning DisorderStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,064 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEE Regina Lai Tong, Chinese University of Hong Kong
- Investigators
- Regina Lee, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112483
- Sponsor's protocol ID
- 2022.659-T
- Acronym
- SEN
- Status last verified
- Oct 2023
- First submitted
- 21 Aug 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee RLT, Lane S, Brown G, Leung C, Kwok SWH, Chan SWC. Systematic review of the impact of unstructured play interventions to improve young children's physical, social, and emotional wellbeing. Nurs Health Sci. 2020 Jun;22(2):184-196. doi: 10.1111/nhs.12732.
PubMed 32358875Lee RLT, Chan SWC, Chong YY, Chau SWH, Choi KC, Chien WT. Effects of a SWELE program for improving mental wellbeing in children and adolescents with special educational needs: protocol of a quasi-experimental study. BMC Pediatr. 2024 Dec 6;24(1):800. doi: 10.1186/s12887-024-05288-8.
PubMed 39643869
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWELE Programme: An Unstructured Outdoor Play With Mindfulness-based Interventions to Promote Mental Health Among Children and Adolescents With Special Education Needs
- ClinicalTrials.gov ID
- NCT06112483
- Acronym / sponsor ID
- SEN / 2022.659-T
- Conditions
- Specific Learning Disorder, Intellectual Disability, Mild to Moderate, Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Physical Disability
- Keywords
- Unstructured play, Mindfulness-based interventions, Special education needs, Children and adolescents, Emotional, Anxiety, Depression, Self-regulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,064 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Nov 2023 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 14 Jul 2024 (estimated)
- First posted
- 1 Nov 2023 (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 is an observational study with the aim of SWELE Programme is to raise mental health knowledge and awareness by implementing a play-based approach on Supporting Wellness in E-Child Learning Environments (SWELE) programme combining unstructured outdoor play activities with mindfulness-based interventions to promote mental health in children and adolescents with special education needs (SEN), in the context of the COVID-19 pandemic.
This is a 16-week SWELE programme and it will be conducted in two batches. Each batch has three special schools. The main activities include: One training workshop for three groups in each special school: 1) Scout Leaders (special schools' teachers), 2) SEN students (scouts in the school) to become Youth Mental Health Ambassadors and 3) for parents, school social workers, school nurses, schoolteachers and stakeholders; 30 minutes unstructured outdoor play with mindfulness activities 2 times per week for 16 weeks
After participated the SWELE programme, the primary outcomes include reducing anxiety symptoms, reducing negative emotions, improving social skills in peer relationships; and changing in playfulness level among SEN children and adolescents.
Main activities of SWELE programme:
- Unstructured outdoor free play integrated into the school's extra-curricular activities (Youth Mental Health Ambassadors) to promote SEN students' mental health for objectives 1-4.
- Use mindfulness-based podcasts, mindfulness games, mindfulness art for objectives 1-2.
- Through meditation and deep breathing technique, storytelling with relaxing waves piano music, yoga and mindful art for objectives 1-2.
- Training Workshops (Training of trainers) for Scout Leaders who will implement SWELE program in each special school.
- Youth Mental Health Ambassador Program for SEN students who are enrolled in Scout Club in each special school; SWELE training workshops for parents and schoolteachers will also be held in each special school for objectives 1-4.
- Examples of unstructured play might be creative play alone or with others, including artistic or musical games. imaginative games - for example, making cubbyhouses with boxes or blankets, dressing up or playing make-believe, exploring new or favorite spaces like school backyards, parks, playgrounds and so on.
Detailed description
Intervention: SWELE Program:
How does this SWELE programme combine unstructured outdoor play with mindfulness-based interventions is different from other existing services in the community? This 16-week programme focuses on Supporting Wellness in E-Child Learning Environments (SWELE) programme by combining unstructured outdoor play with mindfulness-based interventions to promote mental health in SEN students, in the context of the COVID-19 pandemic. There is no such SWELE programme to promote mental health for SEN students in Hong Kong, especially in the context of COVID-19 pandemic. Six special schools have been recruited and they would participate the SWELE programme.
A playful approach of unstructured play has also been found effective on promoting positive emotions and emotional competence among early adolescents. Unstructured Outdoor Play coupled with Mindfulness-based Interventions via SWELE programme to Promote Mental Health for children and adolescents with SEN during COVID-19 pandemic. Very limited unstructured outdoor play-based programme integrated into the extra-curricular activities in the special schools in Hong Kong.
The COVID-19 pandemic has resulted in increased anxiety and stress among children and adolescents in Hong Kong. In order to help alleviate these symptoms, the project team of the SWELE program is collaborating with The Scout Association of Hong Kong on a 16-week SWELE programme to promote SEN students' mental health. The mindfulness-based interventions focus on social-emotional learning activities in schools. Without intentional social-emotional development, SEN students may not learn how to process their emotions and connect with other in healthy ways. That is where mindfulness can come in. What is mindfulness? Mindfulness involves both an awareness and an acceptance of both the world around us and our internal experiences. Mindful people tend to focus more on the present instead of reflecting on the past or future, and they cultivate a curiosity towards their thoughts, emotions, or physical sensations.
The new knowledge generates from the findings of this mental health promotion project are important for raising the public's awareness about the impact on SEN student's mental health and advancing our understanding of the COVID-19 pandemic's impacts on service disruption and transition and subsequently on concerning SEN students' mental health. Thus, school health policy and strategies should be developed appropriately in promoting SEN
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and adolescents with special education needs | – | Behavioral: SWELE ProgrammeChildren and adolescents with special education needs, including (a) specific learning difficulties; (b) intellectual disability; (c) autism; (d) attention deficit hyperactivity disorder; (e) physical disabilities. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents aged 6-18 years old with mild to moderate physical and intellectual disabilities (SEN students) from six selected special schools. They will be recruited and participated the SWELE Programme.
Key inclusion criteria (5 listed)
- are studying in a special school;
- can speak and understand Cantonese
- have no diagnosis of any cardiovascular disease
- can provide parental consent
Key exclusion criteria (5 listed)
- are not studying in a special school;
- do not speak and understand Cantonese
- have been diagnosed with cardiovascular disease
- do not provide parental consent
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 |
|---|---|---|
| SWELE ProgrammeAlso: Unstructured play with mindfulness-based interventionsThis 16-week programme focuses on Supporting Wellness in E-Child Learning Environments (SWELE) programme by combining unstructured outdoor play with mindfulness-based interventions to promote mental health in SEN students, in the context of the COVID-19 pandemic. There is no such SWELE programme to promote mental health for SEN students in Hong Kong, especially in the context of COVID-19 pandemic. A playful approach of unstructured play has also been found effective on promoting positive emotions and emotional competence among early adolescents (Harn \& Bo, 2019). Unstructured Outdoor Play coupled with Mindfulness-based Interventions via SWELE programme to Promote Mental Health for children and adolescents with SEN during COVID-19 pandemic. Very limited unstructured outdoor play-based programme integrated into the extra-curricular activities in the special schools in Hong Kong. | Behavioural | Children and adolescents with special education needs |
Primary outcome
Change scores from baseline to 16 weeks in SEN students' mood using the Mood Scale
Time frame: 16 weeks
To reduce over 80% of SEN students' low mood after participated the 16-week SWELE programme. The Mood Scale includes five different emoji with a 5-points response scale of mood ranging from 1-5: 1-Very bad; 2-bad, 3-so-so, 4-good; to 5-very good. The range of scale score can be from 1 to 5 where higher scores represented very good mood and emotion.
Change scores from baseline to 16 weeks in SEN students' anxiety symptoms using the Chinese version of the short-form State-Trait Anxiety Inventory (STAI-S-6 & STAI-T-7)
Time frame: 16 weeks
To reduce over 80% of SEN students' anxiety symptoms after participated the 16-week SWELE programme. The Chinese version of short-form of State-Trait Anxiety Inventory (STAI-S-6 \& STAI-T-7) demonstrates sound psychometric properties to evaluate the anxiety level. Observers will be asked to rate each item using the following scale (Scale of 1-4; 1 = not at all, 2 = a little, 3 = moderate, 4 = extremely). The range of score from 13 to 52. The mean of the Inventory will be calculated and the mean difference will be compared between the baseline and at 16 weeks. The higher score shows a higher level of anxiety.
Change scores from baseline to 16 weeks in SEN students' behavior regulations (classroom self-regulation and social skills) using the Child Behavior Rating Scale (CBRS)
Time frame: 16 weeks
To increase over 70% of SEN Students' self-regulation and social skills after participated the 16-week SWELE programme. The Child Behavior Rating Scale (CBRS) consists of 17 items that measure children's behavioral regulation as illustrated by two subscales: the Classroom Self-Regulation subscale (10 items) and Social Skills subscale (7 items) that assess teachers' perceptions of children's behavioral regulation in social situations. Observers/teachers will be asked to rate each item using the following scale (Scale of 1-5; 1 = not at all, 2 = a little, 3 = sometimes, 4= always, 5 = often). The range of score from 17 to 85. Scores The mean of the scale will be calculated with the mean difference will be compared between the baseline and at 16 weeks. The higher score shows a high anxiety level of individual.
Change scores from baseline to 16 weeks in SEN students' playfulness using the Children's Playfulness Scale (CPS)
Time frame: 16 weeks
To increase 70% of SEN students' playfulness after participated the 16-week SWELE programme. Children's Playfulness Scale (CPS) is a 23-item, and it was used by teachers evaluate the children's behavior. This 5-point Likert scale is designed to assess children's playfulness based on five dimensions: physical spontaneity, social spontaneity, cognitive spontaneity, manifest joy, and sense of humor. Each item poses a statement such as "the child uses unconventional objects in play," which is scored on a 5-point Likert-type scale with responses ranging from "sounds exactly like the child" to "doesn't sound at all like the child".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Background: PubMed 32358875Lee RLT, Lane S, Brown G, Leung C, Kwok SWH, Chan SWC. Systematic review of the impact of unstructured play interventions to improve young children's physical, social, and emotional wellbeing. Nurs Health Sci. 2020 Jun;22(2):184-196. doi: 10.1111/nhs.12732.
- Derived from this study: PubMed 39643869Lee RLT, Chan SWC, Chong YY, Chau SWH, Choi KC, Chien WT. Effects of a SWELE program for improving mental wellbeing in children and adolescents with special educational needs: protocol of a quasi-experimental study. BMC Pediatr. 2024 Dec 6;24(1):800. doi: 10.1186/s12887-024-05288-8.
Related trials for Specific Learning Disorder
Active, not recruiting
Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation
Autism Spectrum Disorder, Attention Deficit Disorder With Hyperactivity (ADHD)
Not yet recruitingPhase 3
A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment
Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer
Not yet recruiting
Immediate Effects of Active Prisms on Reading Automaticity and Motor Control in Young Adults With Developmental Dyslexia
Developmental Dyslexia
Active, not recruitingObservational study
The Effectiveness of Respiratory Muscle Training and Exercise in Obese Adolescents
Obesity (Disorder)
Active, not recruiting
Let's Know!2: Language-focused Intervention for Children at Risk of Comprehension Difficulties
Language Disorders in Children
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.
Regina Lee, PhD principal investigator
Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
An observational study of Specific Learning Disorder and Intellectual Disability, Mild to Moderate, run by Chinese University of Hong Kong.
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 5 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 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Regina Lai Tong Lee, PhD (852-39433519, reginalee@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change scores from baseline to 16 weeks in SEN students' mood using the Mood Scale (time frame: 16 weeks). The study lists 4 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 NCT06112483, which also lists 2 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 1 Nov 2023.