An interventional study of Mental Health Prevention and Promotion in Psychological Well-Being, sponsored by Little Lions Child Coaching. Active, not recruiting at 1 site in South Africa. Open to participants aged 8 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Little Lions Child Coaching · Not applicable, Interventional, and Prevention
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Among 13 studies in Psychological Well-Being with a site in South Africa — 2 open to participants now, 6 under way, none of them phase 3. Psychological Well-Being · South Africa.
Among the 13 studies in Psychological Well-Being with a site in South Africa, this one is the 7th largest by planned enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2024, is one of 12 with no phase, and was the 9th registered.
2,197 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
Browse Psychological Well-Being studies →2 of the 13 studies in Psychological Well-Being with a site in South Africa are open now. Recruiting first, the newest first:
Emory University · Sites in South Africa
Ages 18+ · Men only · Healthy volunteers
Gabriela Ilie · Sites in South Africa, Belgium, Canada and 2 more countries
Ages 18+ · Men only · Healthy volunteers
A study can be open while its sites in South Africa have not opened yet or have stopped. Only those recruiting at a site in South Africa →
Of the 401 Psychological Well-Being studies recruiting now, 218 (54%) set no upper age limit and 157 (39%) stop at 75 or younger; 120 take children under 18; 204 take healthy volunteers.
This study: 8 Years to 13 Years · all sexes · healthy volunteers too.
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13 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2024.
This study's planned enrollment of 150 is above the median of 110 across 1,798 interventional studies indexed under Psychological Well-Being.
Median enrollment 155 across the 12 interventional studies, 107 across the 1 observational. Of the 7 that completed or were terminated, 4 (57%) have results posted.
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None of the 13 has an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Little Lions Child Coaching as lead sponsor.
Little Lions Child Coaching has 1 study filed under Psychological Well-Being — fewer than ten, so there is no comparison to draw.
3 of the studies in Psychological Well-Being with a site in South Africa that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06985641University of Maryland, College ParkKhanya Ekhaya: A Home-Based Intervention | 2026-11-23 |
| NCT05933226University of Maryland, College ParkProject Khanya: Peer-Delivered Intervention to Improve HIV Medication Adherence and Substance Use in South Africa | 2027-02 |
| NCT07226323Emory UniversityTesting the WeCare Intervention to Address Mental Health and Medication Adherence Challenges Among MSM in South Africa | 2027-07-31 |
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Among the 13 studies in Psychological Well-Being with a site in South Africa, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Behavioural/ psychosocial intervention (i.e., mental health prevention and promotion programme) to boost emotional awareness, confidence, coping skills, and resilience.
Behavioral: Mental Health Prevention and Promotion
Participants in the control group will receive the intervention at a later stage.
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.
Also known as: Inner Lion Programme
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.
Time frame: At baseline and in 6 weeks
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact caitlin@littlelionschildcoaching.com
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Dec 2024, 3 months after the start.
Of 1,261 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 3 months is below that.
Counting every sponsor, half of 1,304 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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