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Article History

Received: 19 May 2025

Accepted: 9 June 2025

First Online: 24 September 2025

Declarations

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: To ensure scientific integrity, participant safety, and adherence to ethical principles, the study underwent a rigorous multi-level ethical review and approval process. The protocol was first submitted to the African Population and Health Research Center’s (APHRC) internal Scientific Review Committee (SRC) which assessed its scientific soundness and ensured that the study promotes the safety and well-being of human participants and adheres to ethical principles. Following internal review, the protocol was submitted to and approved by Amref Health Africa’s Ethics and Scientific Review Committee (ESRC: Approval number P1665/2024). Additionally, it was reviewed for further ethical scrutiny and approved by the Jaramogi Oginga Odinga Teaching and Referral Hospital’s Institutional Scientific Ethics Review Committee (JOOTRH ISERC: Approval number ISERC/JOOTRH/077/24). After securing ethics approvals, the study team obtained a research permit from the National Commission for Science, Technology and Innovation (NACOSTI) ensuring compliance with national research regulations. Final approvals were granted by Nairobi and Kisumu Counties, allowing the study to proceed within these counties.To ensure transparency and ethical integrity, we will provide a comprehensive explanation to study participants of the research purpose, procedures, potential risks, benefits and data usage before obtaining consent. Firstly, the consent procedures will include a section explaining that children will undergo scanning at a convenient time, preferably while asleep to minimize movement and enhance scan quality. We will explain that the procedure will last approximately 20–30 min, and that only the child’s head will be scanned to ensure minimal discomfort. Secondly, we will include a section informing the caregivers about the potential risks associated with the scanning process such as possible anxiety due to the confined space of the MRI scanner. We will also mention that the scans will be conducted by radiographers while explaining every step to the caregiver before the procedure begins. Strategies such as play-based acclimatization techniques will be used to help children feel comfortable. Thirdly, we will detail the indirect benefits of the MRI scan for their children including sharing our results with caregivers and stakeholders to inform better policies and practices that promote positive caregiver-child interactions. We will highlight that if an abnormal finding is detected, the child will be referred to appropriate care for further evaluation and support. Written informed consent will be obtained from eligible participants, ensuring they fully understand the study and voluntarily agree to participate. Complex medical terms will be translated into simple, accessible language to enhance understanding.The study participants and the research team will sign the respective sections of the informed consent form. For individuals who cannot read or write, the consent form will be read and explained to them, and their thumbprint will be obtained in lieu of a written signature, witnessed by a designated witness. In cases where potential participants have disabilities that limit their ability to read or write, a witness will provide a written signature to confirm consent. A distinct consent process will be conducted for the neuroimaging component, ensuring that only those who explicitly agree will have their children undergo MRI scans. The study will utilize a low-field MRI machine which has been demonstrated to be safe for young children (Arnold et al., 2023). Brain measurements will be taken while the child is asleep to minimize movement and interruptions during the scan. Children will be accompanied by caregivers to reduce stranger anxiety and enhance comfort. We will encourage the caregivers to use soothing techniques as needed to help their children remain calm. Prior to MRI scanning, we will conduct sensitization and awareness meetings to ensure participants fully understand the procedure. Radiographers will provide step-by-step explanations to caregivers before the scan begins. If a child wakes up during the scan, the radiographers will request caregivers to soothe them back to sleep to ensure successful imaging.The MRI scanning room will be restricted to study participants and authorized personnel, ensuring confidentiality and minimizing external interference. The radiographer will strive to complete each scan within the allocated 30-minute timeframe. After each scan, the radiographer will verify the quality of the images for accuracy before securely uploading them to the designated server. Strict data protection protocols will be followed to safeguard participant information.All face-to-face interviews with study participants will be conducted in quiet, distraction-free locations, ensuring confidentiality and participant comfort. Efforts will be made to create a welcoming and secure environment, allowing participants to engage openly without external disruptions.To ensure confidentiality, security and compliance with APHRC’s Data Protection and Privacy Policy we will implement a robust data management framework that safeguards participant information throughout the study. All collected data will remain private and will not be shared with anyone outside the research team. The data will be processed and shared exclusively through the shared analysis platform, ensuring controlled access. De-identification will be conducted at the initial data collection and entry stages, using unique codes for both MRI and behavioral datasets. Participant information will be assigned a randomized number instead of demographic details, ensuring anonymity. Only authorized researchers will have access to the coded data, which will be securely stored. This will ensure data integrity and prevent unauthorized use. All research data entered into computers and analysis software (FlyWheel) will be password-protected.Participants will be informed that their data will be stored for five years post-study, in line with APHRC’s Data Protection and Privacy Policy. After five years, all study data will be permanently destroyed to uphold privacy standards. De-identified data will be shared with researchers upon reasonable request, ensuring ethical use while maintaining participant confidentiality.Prior to any data collection activities in the two study counties, all research field interviewers and research team members will be required to sign a Data Confidentiality Agreement form. This measure will promote confidentiality, ethical compliance and data protection throughout the study.Participants will be informed that participation is entirely voluntary, and they are not obligated to take part in the study if they do not wish to do so. If they choose not to participate, they will be assured that they can continue with their normal activities and will still receive all the regular community services. If a participant wishes to withdraw participation after enrolling, they will be informed that they may do so at any time by informing a research team member. Upon withdrawal, their data will no longer be collected, and any previously collected data will be permanently destroyed to uphold privacy and ethical standards.Participants will be informed that the study does not provide direct benefits to them. However, the knowledge generated will be shared with the public to enhance understanding of caregiver-child interactions and brain development. The findings will contribute to improved policies and practices that support optimal early childhood development.Participants will be informed that they will not receive direct financial compensation for their participation. However, we acknowledge that some individuals may need to travel long distances to attend scheduled interviews. To minimize financial burden, a standard transport reimbursement of Kenya Shillings 500 (equivalent to USD 4) will be provided to cover travel expenses for those who incur costs.

: Not applicable.

: The authors declare no competing interests.