Impact of Preventive Mental Health Programme on Social/Emotional Functioning and Resilience in Children in South Africa

NCT06445777 | Active Not Recruiting

• 1 other identifier: LLRCT
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychological Well-Being

Keywords

Emotional Resilience; Mental Health Prevention; South Africa; Universal Mental Health Promotion

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline and in 6 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Participants in the control group will receive the intervention at a later stage.

Interventions

Mental Health Prevention and Promotion BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Little Lions Child Coaching: lead
• University of Cape Town: collaborator
• King's College London: collaborator

Study Sites (1)

Neighbourgood

Cape Town, Western Cape, South Africa

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Susan Malcolm-Smith

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The researchers involved in data collection after the intervention will be masked.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: August 19, 2024
• Primary Completion: December 10, 2024
• Study Completion: March 31, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

ZA (1)