Mphatlalatsane: Early Morning Star

ISRCTN	ISRCTN16654287
DOI	https://doi.org/10.1186/ISRCTN16654287
Protocol serial number	Internal ethics review board reference number: N14/09/127
Sponsor	Stellenbosch University
Funder	United States Agency for International Development

Submission date: 25/06/2015
Registration date: 03/07/2015
Last edited: 05/08/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The Mphatlalatsane (Early Morning Star) project is an intervention (or programme) that integrates Early Childhood Care and Development (ECCD), HIV testing and treatment services, and nutrition support for families with young children in Lesotho. The intervention was developed to increase early childhood stimulation, HIV testing and treatment and child nutrition for children aged 1-5 years. The program will be implemented in 34 villages in the Mokhotlong district of Lesotho, making use of a community-based participatory approach to intervention development. The project aims to make use of the existing pre-school centers that are based in the villages to deliver the intervention to families in the Mokhotlong district. In addition to the intervention sessions delivered at the preschools, local organizations will be mobilized to co-ordinate community outreach days that aim to increase HIV testing among families through promoting an overall focus on child health.

Who can participate?
The intervention is designed for primary caregivers and their children between the ages of 1 and 5 years. Caregivers will be invited to attend the intervention program with their children.

What does the study involve?
The intervention consists of 2-3 hour sessions weekly for 8 consecutive weeks, delivered to groups of 5/6 carers and their children at a time. The sessions include group and individual activities and make use of group presentations, video materials and practical exercises. The intervention teams (comprised of two facilitators) give sessions to caregivers and their children to address critical factors for early child development, health and growth. For growth and health, the intervention focuses on key messages and identifying available resources/services in the primary caregiver’s environment to motivate positive practices. For ECCD, the caregiver receives training in building sensitive “book-sharing” skills – a strategy that stimulates the child cognitively and encourages caregiver-child engagement. As part of the book-sharing component, carers also receive a picture book and take-home card at the end of each session that include a summary of the important messages from the session. Carers are encouraged to apply what they learned during the session with their children at home by using the picture book. They will receive a different picture book to take home each week.

What are the possible benefits and risks of participating?
Discussing parenting experiences and HIV and other content in the intervention sessions and assessments may cause emotional discomfort to participants. In the event that participants showing signs of extreme distress, facilitators will facilitate referral to local counseling and health services.
On the other hand, participants will be very likely to benefit in terms of improvements in child health and development outcomes if the intervention is successful through their involvement in the intervention groups. They will also receive a number of children’s books over the course of the project that they will be free to keep at the end of the project. The potential benefit to society is substantial: should this study achieve its aims, it will produce a scientifically cost-effective, and scalable community-based intervention, which is deliverable in a low-resource context, for the improvement of child health and development outcomes for children affected by HIV.

Where is the study run from?
The research team has an office in Mokhotlong where the study is based. The study is run by researchers at Stellenbosch University, University College London and Oxford University, in partnership with the University of Reading. The research team works in partnership with a range of other project partners, including the funder USAID, Management Sciences for Health and Grow, a local NGO.

When is the study starting and how long is it expected to run for?
July 2014 to December 2017

Who is funding the study?
USAID through a management contract with Management Sciences for Health.

Who is the main contact?
Professor Mark Tomlinson

Contact information

Dr Mark Tomlinson
Scientific

Department of Psychology
Stellenbosch University
Stellenbosch
7600
South Africa

ORCID ID	0000-0001-5846-3444

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial design with wait-list control group
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Integrating early childhood care and development, HIV testing and treatment support, and nutrition information into rural informal nursery care in Mokhotlong, Lesotho, to improve HIV testing rates, treatment adherence and early childhood development : a cluster randomized control trial.
Study objectives	1. Participation in an integrated HIV testing, treatment and early childhood care and development (ECCD) intervention increases the rate of HIV testing for children aged 12 – 60 months in rural Lesotho 2. Participation in the intervention results in better child cognitive and language outcomes 3. Participation in the intervention increases uptake of ART for children aged 12-60 months after testing 4. Participating in the intervention results in a higher rate of adherence to ART for children aged 12-60 months 5. Participation in the intervention results in better child growth
Ethics approval(s)	1. Health Research Ethics Committee at Stellenbosch University, 02/03/2015, ref: N14/09/127 2. Lesotho Ministry of Health Ethics Committee, 19/05/2015, ref: 138-2014
Health condition(s) or problem(s) studied	HIV testing and treatment, early childhood care and development, and nutrition
Intervention	The intervention is an integrated early childhood care and development (ECCD), HIV and nutrition intervention. It is targeted at caregivers with children between the ages of 1 and 5 years. Primary caregivers attend groups sessions over 8 weeks with their children, followed by monthly consolidation sessions over 1 year. Children will be divided into groups based on their age so that younger children (12-30 months) and older children (31-60 months) receive the intervention in different groups. The intervention differs slightly by the two age groups, and the two variations are called the Infant and Toddler Intervention and the Child Intervention. The intervention will be hosted in local village preschool centres. An intervention facilitator (IF) and community-based mentor (CBM) will work together to deliver the sessions, each focusing on a different component of the intervention. The IF will deliver the ECCD component of the intervention while the CBM will deliver the HIV and nutrition component. The early childhood development component consists of caregiver training in sensitive “book-sharing” skills – a strategy that stimulates the child cognitively and encourages caregiver-child engagement. The HIV and nutrition component consists of key messages and facilitating the identification of available resources/services in the primary caregiver’s environment to motivate positive practices. The intervention consists of group sessions with 5-6 caregivers and their children which last for 2-3 hours, and are held weekly for 8 consecutive weeks. This initial period is followed by one monthly groups/visits by members of the intervention team over the course of a 12 month period. Each intervention session consists of a session involving group activities and a short individual session. The sessions include group and individual activities and makes use of presentations and practical exercises. The control group will not receive the intervention during the intervention period. However during the project duration, local organisations will be capacitated and trained to roll out the intervention to the other villages upon completion of the trial, and will be supported in doing so by project partners.
Intervention type	Behavioural
Primary outcome measure(s)	All measures will be implemented at baseline, 3 months and 12 months. 1. HIV testing rate (no. of children who have tested for HIV in past 3 months) 2. Child language (MacArthur Communication Development Inventory, Peabody Picture Vocabulary Test, Mullen Receptive Language Scale) 3. Child attention (Early Childhood Vigilance Task)
Key secondary outcome measure(s)	All measures will be implemented at baseline, 3 months and 12 months. 1. Child cognitive development (Mullen Visual Reception Scale) 2. Child growth: Z scores, based on WHO standards 3. HIV treatment uptake: Number of children initiating ART therapy after testing 4. HIV treatment adherence: ART adherence rates in children, defined as % adhering to ART within defined periods (3 days, 1 week, 1 month) 5. Child emotional and behavioural functioning: Child Behaviour Checklist (selected subscales), Strengths and Difficulties Questionnaire 6. Child executive function: Inhibitory control task, Attention shifting task, Working memory task 7. Parental discipline: Discipline and Violence Questionnaire of Lansford and Deater-Deckard, developed from the Parent-Child conflict tactics scale and the World-SAFE survey, 4. Directly observed prohibition task rated with adapted version of the Murray Global Rating Scales 8. Parenting stress: Parenting Stress Index 9. Parental sensitivity: Directly observed book sharing task rated with adapted version of the Murray Global Rating Scales 10. Caregiver mental health: Patient Health Questionnaire – 9, Self-Reporting Questionnaire – 20, Shona Symptom Questionnaire
Completion date	31/12/2017

Eligibility

Participant type(s)	Mixed
Age group	Mixed
Lower age limit	12 Months
Upper age limit	60 Months
Sex	All
Target sample size at registration	1160
Total final enrolment	1040
Key inclusion criteria	In total, 1160 children and their primary carers living in 32 villages near Mokhotlong and their caregivers will be enrolled in the study. Villages have been selected based on them falling within two community councils, having an informal preschool, and being within the geographical area receiving services from the community-based partner of the study. Inclusion criteria for children include: 1. Ages 12-60 months at baseline 2. Has an adult primary caregiver who lives in the household who consents to participate in the study Inclusion criteria for adults include: 1. Age 18 or older 2. Serves as the primary caregiver of the child participant 3. Lives in the house at least 4 nights per week
Key exclusion criteria	N/A
Date of first enrolment	29/06/2015
Date of final enrolment	31/08/2016

Locations

Countries of recruitment

Lesotho

Study participating centre

Mokhotlong District

Mokhotlong
-
Lesotho

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		21/12/2023	27/12/2023	Yes	No
Protocol article		09/11/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

05/08/2025: Corrected publication URL.
27/12/2023: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
01/11/2018: Publication reference added.
14/06/2016: Changed overall trial end date from 30/06/2016 to 31/12/2017. Changed recruitment end date from 31/12/2015 to 31/08/2016. Changed number of villages taking part in the study from 32 to 34.