- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07758283
Intergenerational Risk and Resilience of Rohingya in Displacement (iRRRd)
Understanding the Role of Play and Playful Learning for Resilience in Humanitarian Contexts: A 36-Month Follow-up For A Landmark Longitudinal Prenatal and Early Years Cohorts Study With Rohingya and Host Communities in Cox's Bazar, Bangladesh
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.
Přehled studie
Postavení
Detailní popis
Background and rationale. By 2024, an estimated 117.8 million people globally had been forcibly displaced by persecution, armed conflict, or other human rights violations (UNHCR, 2026). The vast majority reside in low- and middle-income countries (LMICs). The Rohingya refugees in Cox's Bazar, Bangladesh - numbering over one million - represent one of the world's largest and longest-standing refugee populations. A substantial body of research has established that exposure to trauma and adversity before and during pregnancy can affect offspring development through neurobiological mechanisms including fetal programming and intergenerational epigenetic transmission, as well as through postnatal disruptions to caregiving. Despite the scale of this global challenge, large-scale longitudinal studies of early child development in humanitarian contexts that begin prenatally remain extremely rare.
The iRRRd study was designed to address this gap. Drawing on Bronfenbrenner and Morris' bioecological systems framework, it captures risk and protective factors spanning multiple levels - from molecular processes to household and family dynamics to broader contextual forces such as camp governance, humanitarian infrastructure, and environmental stressors - through a multi-method, interdisciplinary approach combining qualitative, survey, observational, physiological, and neurobiological data.
The 36-month wave. The 36-month time point is a critical developmental window: cognitive, language, social-emotional, and behavioral development can be more reliably measured using gold-standard instruments; executive function (EF) emerges as a distinct and predictive construct; and caregiver-child playful interactions become more observable and directly relevant to developmental outcomes. This wave extends the longitudinal scope from infancy into toddlerhood, enabling examination of developmental trajectories from the prenatal period through early childhood.
A central scientific focus of this wave is the role of play and playful caregiver-child interactions as a source of resilience. Preliminary data from older siblings of enrolled children suggest that playful interactions buffer EF development specifically when mothers are experiencing elevated psychological distress. The 36-month wave allows formal testing of this and related hypotheses with the target cohort.
Key hypotheses. Guided by the bioecological framework above, this wave is designed to test several related hypotheses: (H1) caregiver-child playful interaction quality will buffer the association between maternal psychological distress and child cognitive/executive function outcomes, such that the association is attenuated at higher observed play quality; (H2) maternal executive function and autonomic regulation (HRV) will each independently predict caregiver-child interaction quality, which will in turn mediate the association between maternal functioning and child developmental outcomes; (H3) child psychosocial adversity (CPAS) will be associated with poorer child cognitive, executive function, and behavioral outcomes, and this association will be moderated by caregiver mental health and caregiving quality; (H4) physiological synchrony between mother and child during the caregiver-child interaction observation, indexed by concurrent HRV, will be positively associated with interaction quality and, secondarily, with child self-regulation outcomes. These hypotheses will be tested using the primary and secondary outcomes and the predictor, mediator, and moderator measures specified above.
Exploratory biological analyses. In parallel with the confirmatory hypotheses above, the study maintains a biobank of saliva and buccal swab specimens (described in Part 4) that will support exploratory, hypothesis-generating analyses as funding and laboratory capacity permit. Planned exploratory work includes untargeted and targeted proteomic and metabolomic profiling (e.g., inflammatory markers, steroid hormones including cortisol, oxylipins) and epigenetic analyses (e.g., DNA methylation, telomere length). Because the analytic pipelines, sample subsets, and quality-control criteria for these assays are still being finalized, this work is not registered as formal outcome measures in this record. Findings will be reported as exploratory, and specific analyses will be preregistered separately on a per-study basis once hypotheses and analytic plans are finalized.
Note on timing of registration. The iRRRd study began in 2023 and was not preregistered at inception due to logistical and timing constraints inherent to launching large-scale research in a complex humanitarian context. This registration is filed prospectively with respect to the 36-month data collection wave. See Brief Summary for details on the timing of registration relative to fieldwork. Data from Waves 1-5 were collected without registration; analyses of those data are not governed by this registration, though individual papers are being preregistered on an individual basis.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
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Cox's Bazar
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Ukhiya, Cox's Bazar, Bangladéš, 4750
- Rohingya camps, host communities
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Mother/primary female caregiver was enrolled in the iRRRd prenatal cohort (recruited February 2023 - March 2024 when pregnant)
- Target child is alive and 36 months of age (+/- 2 months)
- Household can be located and reached within the study area
- Caregiver provides informed consent for continued participation
Exclusion Criteria:
- Target child has died prior to the 36-month visit
- Household has permanently migrated out of the study area and cannot be located
- Caregiver is in severe acute distress and unable to participate safely
- Caregiver refuses continued participation
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Cognitive Development
Časové okno: 1st of 3 visits at 36 months of age
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Instrument: Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-IV) - Cognitive subscale; directly administered
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1st of 3 visits at 36 months of age
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Executive Function
Časové okno: Visit 1 of the 36-month follow-up
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Directly administered tasks adapted for cultural and contextual appropriateness with Rohingya and host community children. Assessment of inhibitory control & cognitive flexibility (Fruit Stroop), Attention Control ("Walking on line / oval holding bell"), working memory (Tracking Hidden Object). |
Visit 1 of the 36-month follow-up
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Child physical growth and nutritional status
Časové okno: Visit 3 of 36-month follow-up
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Standardized anthropometric measurements: weight (digital scale, 0.1 kg precision), standing height (stadiometer, 0.1 cm precision), mid-upper arm circumference (MUAC; non-stretch tape, left arm) All measurements taken twice (third if discrepancy exceeds threshold: ±100g weight, ±0.5cm height, ±1mm MUAC).
World Health Organization (WHO) 2006 Child Growth Standards z-scores derived.
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Visit 3 of 36-month follow-up
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Child prosocial behavior
Časové okno: Visit 3 of 36-month follow-up
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Prosocial Battery - 6-task directly administered behavioral battery: Sharing (non-costly and costly), Helping (instrumental and empathetic), Caring (pain response and sadness response) Assessor enacts scripted behavioral scenarios using standardized props; child responses recorded on tablet by a scorer.
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Visit 3 of 36-month follow-up
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Child autonomic nervous system functioning - parasympathetic
Časové okno: Visit 3 of 36-month follow-up
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Heart rate variability (HRV) via Firstbeat Bodyguard3 electrocardiogram (ECG) recorder. The child wears the HRV device ideally throughout Visit 1, including a 5-minute baseline period and during the prosocial battery and Engage caregiver-child observation. Wearing the device during both tasks would enable modeling of physiological synchrony between mother and child during the Engage observation. The device will be removed after the baseline period if the child is not content with it, to avoid interfering with other assessment tasks. HRV data are processed by the UC Davis team. |
Visit 3 of 36-month follow-up
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Child behavioral problems (caregiver report)
Časové okno: Visit 2 of 36-month follow-up
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Strengths and Difficulties Questionnaire (SDQ) - parent-report version.
The SDQ is used to assess child behavioral problems across subscales including emotional symptoms, conduct problems, hyperactivity/inattention, and peer problems.
The SDQ is administered without modification in accordance with its licensing terms.
Note: the SDQ prosocial subscale is not a primary focus of this wave; prosocial behavior is assessed via the directly administered Prosocial Battery (Secondary Outcome 2).
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Visit 2 of 36-month follow-up
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Alice J Wuermli, PhD, New York University
- Vrchní vyšetřovatel: Fahmida Tofail, PhD, international center for diarrheal disease research, Bangladesh
- Vrchní vyšetřovatel: Paul Hastings, PhD, University of California, Davis
Publikace a užitečné odkazy
Obecné publikace
- Ahamed S, Ugarte E, Elahi M, Hossain E, Rahman S, Sanin KI, Dutta A, Dutta GK, Wuermli AJ, Tofail F. Association Between Birth Outcomes and Gestational Weight Gain Among Forcibly Displaced Rohingya and Nearby Host Community, in Cox's Bazar, Bangladesh. Life (Basel). 2025 Nov 19;15(11):1773. doi: 10.3390/life15111773.
- Elahi M, Sanin KI, Rahman MS, Hiott C, Ugarte E, Ahamed MS, Hossain MM, Hossian E, Mitu SRI, Akhter RM, Roy BR, Dutta GK, Wuermli AJ, Tofail F. Association between mental health and sleep quality among Forcibly Displaced Rohingya pregnant women living in Cox's Bazar, Bangladesh: a cross-sectional observation. BMC Psychiatry. 2026 Jan 16;26(1):103. doi: 10.1186/s12888-025-07561-1.
- Simon D, Michael D, Rahman MS, Hiott MC, Rahim AK, Sanin KI, Tofail F, Wuermli AJ. Predictors of antenatal care utilization among the Rohingya population in the refugee camps of Cox's Bazar, Bangladesh. Confl Health. 2025 Dec 3;20(1):1. doi: 10.1186/s13031-025-00733-6.
- Trang K, Hiott C, Rahim AK, Rahman S, Wuermli AJ. A qualitative study of cultural concepts of distress among Rohingya refugees in Cox's Bazar, Bangladesh. Confl Health. 2024 Jul 30;18(1):48. doi: 10.1186/s13031-024-00606-4.
- Ugarte E, Hastings PD, Hossain E, Ahamed MS, Rahim AK, Elahi M, Rahman MS, Tofail F, Wuermli AJ. A Protocol to Acquire Infant Heart Rate Variability in the Rohingya Camps and Surrounding Communities in Cox's Bazar, Bangladesh. Psychophysiology. 2026 Aug;63(8):e70356. doi: 10.1111/psyp.70356.
- Ugarte E, Hiott MC, Elahi M, Hossain E, Ahamed MS, Rahman MS, Tofail F, Hastings PD, Wuermli AJ. Maternal Mental Health and Infant Parasympathetic Activity in the Context of Forced Displacement: Insights From the Rohingya Camps and Surrounding Communities in Cox's Bazar, Bangladesh. Dev Psychobiol. 2025 Nov;67(6):e70102. doi: 10.1002/dev.70102.
- Wuermli A, Hiott MC, Ugarte E, Rahman MS, Elahi M, Rahim AK, Dutta GK, Ahamed MS, Roy BR, Akhter RM, Hossain E, Michael D, Ayrin TK, Haseen SH, Alam RB, Ratul TI, Horaira MA, Gladstone M, Sanin KI, Raqib R, Hamadani J, Yoshikawa H, Hastings PD, Tofail F. Cohort profile: a prenatal birth cohort study of intergenerational risk and resilience after conflict and forced displacement. BMJ Open. 2025 Nov 4;15(11):e099052. doi: 10.1136/bmjopen-2025-099052.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- A25-0740-001
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