Psychological Well-BeingNCT06445777
Impact of Preventive Mental Health Programme on Social/Emotional Functioning and Resilience in Children in South Africa
A study testing Mental Health Prevention and Promotion in people with Psychological Well-Being, run by Little Lions Child Coaching at 1 site in South Africa.
Trial summary
The goal of this clinical trial is to test the effectiveness of a mental health prevention and promotion programme delivered to children (ages 8 to 13) living in under-resourced communities in South Africa. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Well-Being
- What is being tested?
- Mental Health Prevention and Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Africa
- Study dates
- 19 Aug 2024to 31 Mar 2025
- 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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Between 8 and 13 years old
- Fluent in Xhosa and/or English
- Lives in one of the following communities in Cape Town, South Africa: Khayelitsha, Langa, or Mfuleni
Who cannot join
- Younger than 8 years old or older than 13 years old
- Do not have a strong understanding of the language of instruction (i.e., Xhosa/English)
- Lives in an area outside of Khayelitsha, Langa, or Mfuleni
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to test the effectiveness of a mental health prevention and promotion programme delivered to children (ages 8 to 13) living in under-resourced communities in South Africa.
The main question it aims to answer is:
Does the programme increase resilience and improve psychological well-being?
Participants will be asked to attend the programme twice a week after school for a period of six weeks and complete a series of questionnaires.
Researchers will compare children who attended the programme to those who did not to see if the programme resulted in better social/emotional functioning and resilience.
Read the detailed description
Although the well-being of vulnerable South African children is a significant public health concern, few studies have evaluated the effectiveness of mental health prevention and promotion interventions in low- and middle- income countries. Little Lions Child Coaching is a South African youth-led, community-based non-governmental organisation (NGO) that aims to normalise mental health conversations and empower the next generation to tap into their emotional resilience by providing accessible mental health support to children in under-resourced communities surrounding Cape Town.
The aim of this effectiveness study is to measure how a mental health prevention and promotion programme, designed and implemented by Little Lions Child Coaching, impacts the resilience and social/emotional functioning of children (ages 8 to 13) living in townships surrounding Cape Town.
Participants in the intervention condition will receive the programme twice a week after school for a period of six weeks to boost their emotional awareness, confidence, coping skills and resilience. Resilience scores will be compared to a control group.
- Conditions
- Psychological Well-Being
- Being tested
- Mental Health Prevention and Promotion
- Keywords
- Emotional Resilience, Mental Health Prevention, South Africa, Universal Mental Health Promotion
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health Prevention and PromotionBehavioural
Also called Inner Lion Programme
The Inner Lion Programme is made up of 12 interactive workshops which are based on four key pillars: building confidence by identifying strengths and personal qualities; improving emotional intelligence and self-awareness; establishing adaptive coping strategies and channels of support; and boosting resilience. Professionally created by Child Psychologist Stijn de Leeuw together with an advisory team of psychologists from the Netherlands and South Africa, the programme follows a carefully structured and curated prevention and promotion mental health curriculum with games, crafting activities, psycho-educational stories, dance, movement, and breathing exercises. Workshops are led by local role models (a male-female duo) with lived experience trained to be mental health coaches.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Behavioural/ psychosocial intervention (i.e., mental health prevention and promotion programme) to boost emotional awareness, confidence, coping skills, and resilience. Receives: Behavioral: Mental Health Prevention and Promotion |
| Control Group | No intervention | Participants in the control group will receive the intervention at a later stage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in resilience scores using the Child and Youth Resilience Measure
Higher scores on the Child and Youth Resilience Measure indicate greater resilience. The minimum score is 17 and the maximum score is 51. A t-test will be used to determine whether the control versus intervention group had significantly different mean scores on the Child and Youth Resilience measure after the intervention relative to the baseline assessment.
Measured: At baseline and in 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start19 Aug 2024
- Primary completion10 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Well-BeingStudies 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
- Crossover
- Model description
- Children will be randomly assigned to either the control or intervention group after the baseline assessment. Participants in the control group will receive the intervention at a later stage.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Little Lions Child Coaching
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town, King's College London
- Responsible party
- Sponsor
- Investigators
- Susan Malcolm-Smith, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445777
- Sponsor's protocol ID
- LLRCT
- Status last verified
- Oct 2024
- First submitted
- 31 May 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with an academic interest in the effectiveness of universal mental health interventions for children and adolescents. To protect personal information, all data shared will be coded.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preventive Mental Health Programme on Social/Emotional Functioning and Resilience in Children in South Africa
- ClinicalTrials.gov ID
- NCT06445777
- Acronym / sponsor ID
- LLRCT
- Conditions
- Psychological Well-Being
- Keywords
- Emotional Resilience, Mental Health Prevention, South Africa, Universal Mental Health Promotion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Little Lions Child CoachingUniversity, hospital or other
- Collaborators
- University of Cape Town, King's College London
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 6 Jun 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.
The goal of this clinical trial is to test the effectiveness of a mental health prevention and promotion programme delivered to children (ages 8 to 13) living in under-resourced communities in South Africa.
The main question it aims to answer is:
Does the programme increase resilience and improve psychological well-being?
Participants will be asked to attend the programme twice a week after school for a period of six weeks and complete a series of questionnaires.
Researchers will compare children who attended the programme to those who did not to see if the programme resulted in better social/emotional functioning and resilience.
Detailed description
Although the well-being of vulnerable South African children is a significant public health concern, few studies have evaluated the effectiveness of mental health prevention and promotion interventions in low- and middle- income countries. Little Lions Child Coaching is a South African youth-led, community-based non-governmental organisation (NGO) that aims to normalise mental health conversations and empower the next generation to tap into their emotional resilience by providing accessible mental health support to children in under-resourced communities surrounding Cape Town.
The aim of this effectiveness study is to measure how a mental health prevention and promotion programme, designed and implemented by Little Lions Child Coaching, impacts the resilience and social/emotional functioning of children (ages 8 to 13) living in townships surrounding Cape Town.
Participants in the intervention condition will receive the programme twice a week after school for a period of six weeks to boost their emotional awareness, confidence, coping skills and resilience. Resilience scores will be compared to a control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Children will be randomly assigned to either the control or intervention group after the baseline assessment. Participants in the control group will receive the intervention at a later stage.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Mental Health Prevention and PromotionBehavioural/ psychosocial intervention (i.e., mental health prevention and promotion programme) to boost emotional awareness, confidence, coping skills, and resilience. |
| Control Group | No intervention | –Participants in the control group will receive the intervention at a later stage. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Between 8 and 13 years old
- Fluent in Xhosa and/or English
- Lives in one of the following communities in Cape Town, South Africa: Khayelitsha, Langa, or Mfuleni
Key exclusion criteria (3 listed)
- Younger than 8 years old or older than 13 years old
- Do not have a strong understanding of the language of instruction (i.e., Xhosa/English)
- Lives in an area outside of Khayelitsha, Langa, or Mfuleni
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 |
|---|---|---|
| Mental Health Prevention and PromotionAlso: Inner Lion ProgrammeThe Inner Lion Programme is made up of 12 interactive workshops which are based on four key pillars: building confidence by identifying strengths and personal qualities; improving emotional intelligence and self-awareness; establishing adaptive coping strategies and channels of support; and boosting resilience. Professionally created by Child Psychologist Stijn de Leeuw together with an advisory team of psychologists from the Netherlands and South Africa, the programme follows a carefully structured and curated prevention and promotion mental health curriculum with games, crafting activities, psycho-educational stories, dance, movement, and breathing exercises. Workshops are led by local role models (a male-female duo) with lived experience trained to be mental health coaches. | Behavioural | Intervention Group |
Primary outcome
Mean change from baseline in resilience scores using the Child and Youth Resilience Measure
Time frame: At baseline and in 6 weeks
Higher scores on the Child and Youth Resilience Measure indicate greater resilience. The minimum score is 17 and the maximum score is 51. A t-test will be used to determine whether the control versus intervention group had significantly different mean scores on the Child and Youth Resilience measure after the intervention relative to the baseline assessment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with an academic interest in the effectiveness of universal mental health interventions for children and adolescents. To protect personal information, all data shared will be coded.
Related trials for Psychological Well-Being
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Recruiting
Effects of Red Panax Ginseng Supplementation on Cognitive Performance and Emotional Well-Being in Young Healthy Adults
Mental Acuity
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
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.
Susan Malcolm-Smith principal investigator
University of Cape Town
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Health Prevention and Promotion in people with Psychological Well-Being, run by Little Lions Child Coaching at 1 site in South Africa.
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 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 15 Oct 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 South Africa. 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?
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?
Mean change from baseline in resilience scores using the Child and Youth Resilience Measure (time frame: At baseline and in 6 weeks). 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 15 Oct 2024.