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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06445777
Other study ID # LLRCT
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date December 2024

Study information

Verified date May 2024
Source Little Lions Child Coaching
Contact Impact Manager
Phone 0791374527
Email caitlin@littlelionschildcoaching.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 13 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mental Health Prevention and Promotion
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Little Lions Child Coaching King's College London, University of Cape Town

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change from baseline in resilience scores using the Child and Youth Resilience Measure A t-test will be used to determine whether the control versus intervention group had significantly different mean resilience scores after the intervention relative to the baseline assessment At baseline and in 6 weeks
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