Enhancing the ethical conduct of a longitudinal cluster-randomized trial of psychosocial stimulation intervention for children with complicated severe acute malnutrition through Rapid Ethical Assessment: a qualitative study.

BACKGROUND: Informed consent is a universally accepted precondition for scientific researches involving human participants. However, various factors influence the process of obtaining authentic informed consent, and researchers particularly working in resource-poor countries often face considerable difficulties in implementing the universally recommended procedures for obtaining informed consent. We have conducted this Rapid Ethical Assessment (REA) to accommodate the local cultural norms and to understand the relevant ethical issues in the Silti community before the conduct of a cluster-randomized controlled trial. METHODS: This REA was conducted in two purposively selected Woredas/Districts and Worabe Town administration of Silti Zone. Data were collected using in-depth interviews and focus group discussions. Purposive and convenient sampling techniques were used to select respondents. Five in-depth interviews and 15 Focus Group Discussions were conducted in the Amharic language. The collected data was transcribed, translated, and analyzed using a thematic approach. RESULT: Most of the community members never heard about research and therapeutic misconception was common. In the area, the permission of people working in the formal and informal community administration is essential before approaching individuals. The male head of the household should also be involved in the decision before individual household members participate in research. Furthermore, sensitizing the community using public and religious gatherings was suggested before individual recruitment. In the consent process, delivering selected information particularly the purpose and benefits of the research was emphasized and the tendency of preferring verbal consent was documented despite the willingness of the individuals to sign on the consent form. Local health workers were identified as appropriate personnel to communicate information and the procedures of the research were found to be acceptable. However, the value of small incentives was suggested to motivate potential participants. Finally, involving all concerned stakeholders and respecting the cultural norm of the community was emphasized. CONCLUSION: Through REA, we understand the research awareness of the community, their expectation, and the cultural norms relevant to the ethical conduct of research. It enabled us to devise culturally sensitive and scientifically sound strategies to secure authentic informed consent. The process of conducting REA was found to be feasible, quick, and efficient.

Neither n-3 Long-Chain PUFA Supplementation of Mothers through Lactation nor of Offspring in a Complementary Food Affects Child Overall or Social-Emotional Development: A 2 × 2 Factorial Randomized Controlled Trial in Rural Ethiopia.

BACKGROUND: The n-3 (ω-3) long-chain polyunsaturated fatty acid (LC-PUFA) docosahexaenoic acid (DHA) is essential for optimal brain development. There is a lack of evidence on the effect of postnatal n-3 LC-PUFA supplementation on child development in low-income countries. OBJECTIVE: We evaluated the efficacy of fish-oil supplementation through lactation or complementary food supplementation on the development of children aged 6-24 mo in rural Ethiopia. METHODS: We conducted a double-blind randomized controlled trial of n-3 LC-PUFA supplementation for 12 mo using fish-oil capsules [maternal intervention: 215 mg DHA + 285 mg eicosapentaenoic acid (EPA)] or a fish-oil-enriched complementary food supplement (child intervention: 169 mg DHA + 331 mg EPA). In total, 360 pairs of mothers and infants aged 6-12 mo were randomly assigned to 4 arms: maternal intervention and child control, child intervention and maternal control, maternal and child intervention, and maternal and child control. Primary outcomes were overall developmental performance with the use of a culturally adapted Denver II test that assesses personal-social, language, fine-motor, and gross-motor domains and social-emotional developmental performance using the Ages and Stages Questionnaire: Social Emotional at baseline and at 6 and 12 mo. We used mixed-effects models to estimate intervention effects on developmental performance over time (intervention × time interaction). RESULTS: The evolution in overall and social-emotional developmental performance over time did not differ across study arms (intervention × time: F = 1.09, P = 0.35, and F = 0.61, P = 0.61, respectively). Effects did not change after adjustment for child age, birth order, and nutritional status; maternal age and education; wealth; family size; and breastfeeding frequency. Children's developmental performance significantly decreased during study follow-up (ß: -0.03 SDs/mo; 95% CI: -0.04, -0.01 SD/mo; P < 0.01). CONCLUSIONS: n-3 LC-PUFA supplementation does not affect overall or social-emotional development of children aged 6-24 mo in a low-income setting. Follow-up of the cohort is recommended to determine whether there are long-term effects of the intervention. This trial was registered at clinicaltrials.gov as NCT01817634.

The effects of psychosocial stimulation on the development, growth, and treatment outcome of children with severe acute malnutrition age 6-59 months in southern Ethiopia: a parallel group cluster randomized control trial (EPSoSAMC study).

BACKGROUND: Severe Acute Malnutrition (SAM) remains a major cause of child mortality. To improve the management and survival of children the World Health Organization (WHO) endorsed the protocol for the management of SAM. The protocol suggested the integration of psychosocial stimulation as part of the medico-nutritional care process to prevent the long-term adverse developmental impact of the SAM. However, there is little scientific evidence behind the recommended stimulation intervention. METHOD: A parallel-group cluster-randomized controlled trial will be conducted among 144 children with SAM age 6-59 months in Southern Ethiopia. The study will have two groups where: children with SAM admitted in the intervention health facilities will receive psychosocial stimulation in addition to the routine inpatient care and for 6 months after discharge. Children with SAM admitted in the SC of the control health facilities will receive the routine inpatient care without psychosocial stimulation and home-based follow up for 6 months after discharge. All mothers/ caregivers will also receive uniform health education on child health-related issues. The primary outcome of the study will be child development while the secondary outcomes will include child growth and treatment outcome. All outcomes will be assessed four times: at enrollment, upon discharge from the SC, at 3 and 6 months of follow up. The data will be analyzed using STATA Version 15 Statistical Software. The anthropometric Z-scores and percentile of the median will be calculated child using WHO Anthro Version 3.2.2 Statistical Software. To assess the overall effect of the intervention by controlling other potential contributing factors, a generalized linear mixed model will be used. DISCUSSION: The present study will have an important contribution in generating supplementary evidence regarding the effect of psychosocial stimulation interventions on the development and growth outcomes of children with SAM. The study will further address the impact of the intervention on treatment outcome indicators that are still under-researched areas requiring new scientific evidence. TRIAL REGISTRATION: Pan African Clinical Trials Registry -PACTR201901730324304. Registered 25 November 2018, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5739.