NCT06112483

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,064

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2024

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

August 21, 2023

Last Update Submit

October 31, 2023

Conditions

Keywords

Unstructured playMindfulness-based interventionsSpecial education needsChildren and adolescentsEmotionalAnxietyDepressionSelf-regulation

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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".

    16 weeks

Study Arms (1)

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.

Behavioral: SWELE Programme

Interventions

SWELE ProgrammeBEHAVIORAL

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.

Also known as: Unstructured play with mindfulness-based interventions
Children and adolescents with special education needs

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • SEN students:
  • are studying in a special school;
  • can speak and understand Cantonese
  • have no diagnosis of any cardiovascular disease
  • can provide parental consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 32358875BACKGROUND
  • Lee 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.

MeSH Terms

Conditions

Specific Learning DisorderIntellectual DisabilityAutism Spectrum DisorderAttention Deficit Disorder with HyperactivityAnxiety DisordersDepressionSelf-Control

Condition Hierarchy (Ancestors)

Learning DisabilitiesCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersChild Development Disorders, PervasiveAttention Deficit and Disruptive Behavior DisordersBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Regina Lee, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Regina Lai Tong Lee, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 21, 2023

First Posted

November 1, 2023

Study Start

November 15, 2023

Primary Completion

May 31, 2024

Study Completion

July 14, 2024

Last Updated

November 1, 2023

Record last verified: 2023-10