Clinical Research Directory

Intergenerational Risk and Resilience of Rohingya in Displacement

The iRRRd study is an ongoing prospective longitudinal prenatal birth cohort study based in Cox's Bazar, Bangladesh. Between February 2023 and March 2024, 2,888 pregnant women were enrolled (approximately 80% Rohingya refugees living in camps, 20% Bangladeshi host community). The study aims to investigate (1) the effects of being conceived, gestated, born, and raised in contexts of conflict and forced displacement on child health and development; (2) the mechanisms underlying the intergenerational transmission of conflict and displacement trauma to offspring; and (3) the sources of heterogeneity in these associations across individual, social, biological, and contextual risk and protective factors. Five waves of data collection have been completed: prenatal recruitment (Wave 1), third-trimester follow-up for a subset of the sample (Wave 2), birth (Wave 3), 28 days postpartum (Wave 4), and 6 months postpartum (Wave 5, completed April 2025; N=2,526). This registration covers Wave 6, the 36-month follow-up, in which target children are assessed when they reach 36 months of age. Anticipated enrollment for this wave is approximately 2,200 mother-child dyads. Waves 1-5 were conducted without preregistration due to logistical and timing constraints inherent to launching large-scale research in a complex humanitarian context. Design and preparation for the 36-month wave began in June-July 2025, and field piloting of study procedures and measures began in September 2025. Follow-ups with children reaching 36 months of age began in late May 2026. The original planning estimate of March 2026 reflected the 36-month mark for the earliest-born children in the cohort (first births occurred in March 2023); the ±2-month eligibility window (Part 5) accommodated the modest delay to actual fieldwork start. Up to the first week of August, fieldwork progressed slowly with a smaller number of enumerators, as several measures were still being refined and modified based on ongoing piloting. We consider this wave officially launched once onboarding and training of an expanded group of data collectors is complete and the pace of follow-ups picks up with number of children turning 36 months of age. All field activities that predate this registration are considered piloting and have served to iron out remaining logistical, technical, and language issues, and to finalize decisions on tool and item selection. No data have been analyzed, with the exception of measures for which psychometric properties needed to be examined to inform modification and selection decisions.

Mental Health Support Interventions for Mothers of Infants and Young Children

The goal of this clinical trial is to learn whether a maternal mental health support program can improve maternal mental health and child development when delivered through routine child healthcare services in community health centers in China. The study will also examine how the program works and whether it can be successfully integrated into the child healthcare system. The main questions it aims to answer are: * Does the maternal mental health support program improve maternal mental health and well-being? * Does the program improve child development outcomes? * Through what pathways does the program influence maternal mental health and child development? * Can the program be successfully integrated and delivered within the child healthcare system? Researchers will compare the maternal mental health support program with usual child healthcare services. Participants will: * Receive either the maternal mental health support program or usual child healthcare services * Attend program sessions delivered in community health centers * Complete questionnaires and assessments related to maternal well-being, parenting, and child development * Participate in follow-up assessments during the study period

Effects of Music and Storytelling on Linguistic, Socioemotional, and Adaptive Development in Children Aged 12-36 Months: an Intervention Protocol in Municipal Early Childhood Centers

This randomized clinical trial aims to evaluate the impact of a structured enriched environment on the linguistic, adaptive behavior, and socioemotional development of children aged 12 to 36 months. The study addresses two main questions: Does the intervention improve linguistic, adaptive behavior, and socioemotional development compared to standard care? Does parental guidance amplify the benefits of the intervention? Participants will be randomly assigned to one of two groups: Intervention Group: Children will participate in musical activities twice per week (singing, exploring simple instruments, and musical games) and daily storytelling sessions using interactive and visual aids. Within this group, parents in the "with guidance" subgroup will attend biweekly meetings to learn strategies for reinforcing the intervention at home, while the "without guidance" subgroup will not include parental training. Control Group: Children will receive standard care complemented by alternative artistic and pedagogical activities (e.g., drawing, painting), without the structured intervention.

Parents Together: Supporting Parents to Promote Healthy Behaviours in Children

The Parents Together trial aims to determine if the Parents Together program consisting of virtual parent group sessions and coaching calls, will result in better health outcomes for children. The program which is facilitated by a Public Health Nurse seeks to encourage healthy lifestyle behaviours, help build strong family relationships, and promote child development and mental health.