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Child DevelopmentiRRRdNCT07758283

Intergenerational Risk and Resilience of Rohingya in Displacement

An observational study of Child Development and Early Child Development, run by New York University at 1 site in Bangladesh.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 36 to 38 months
How many people
2,200 participants
Where
1 siteBangladesh
Study dates
15 May 2026to Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 36 to 38 months
  • All sexes
  • No healthy volunteers
  • Child

Study population: The prenatal cohort consists of 2,322 Rohingya women recruited from 8 camps in the Kutupalong camp cluster and 566 women from surrounding host communities in Cox's Bazar, Bangladesh. Rohingya participants, a stateless minority from Rakhine, Myanmar, who fled persecution and violence primarily in 2017-2018. The host community is composed of Bangladeshi nationals from Chittagonian-speaking communities adjacent to the camps. At prenatal recruitment, approximately 68% of Rohingya women were unable to read in any language; mean age was 21.2 years, with approximately 41% under 19 years of age. Consent is obtained verbally - due to high rates of illiteracy - in Rohingya/Chittagonian or Bangla, by female enumerators for female participants and male enumerators for male participants.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • Rohingya camps, host communities

    Ukhiya, Cox's Bazar, 4750

Other trials in Bangladesh

About this study

Official title: 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).

Read more

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.

Read the detailed description

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.

Keywords
Rohingya, refugee, birth cohort, longitudinal, prenatal, Bangladesh, executive function, Bayley, early childhood, play, playful learning, parenting, biomarkers, saliva, epigenetics, heart rate variability, adversity, resilience, LMIC
Medical subject headings
Psychological Well-Being, Combat Disorders, Historical Trauma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive Development

    Instrument: Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-IV) - Cognitive subscale; directly administered

    Measured: 1st of 3 visits at 36 months of age

  2. Executive Function

    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).

    Measured: Visit 1 of the 36-month follow-up

Secondary outcomes (4)

  1. Child physical growth and nutritional status

    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.

    Measured: Visit 3 of 36-month follow-up

  2. Child prosocial behavior

    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.

    Measured: Visit 3 of 36-month follow-up

  3. Child autonomic nervous system functioning - parasympathetic

    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.

    Measured: Visit 3 of 36-month follow-up

  4. Child behavioral problems (caregiver report)

    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).

    Measured: Visit 2 of 36-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2026
  2. Study start15 May 2026
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07758283
Sponsor's protocol ID
A25-0740-001
Acronym
iRRRd
Status last verified
Aug 2026
First submitted
6 Aug 2026
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: There is a shared interest in making data and supporting documentation available. The form of this sharing is still under consideration. The icddr,b IRB generally does not allow public data sharing. The current practice follows a collaborative model: interested outside researchers may explore collaborations on specific analytic projects with current PIs based on which restricted access is given to relevant data alongside support in navigating the intricacies of the study an developing manuscripts.

Publications

  • 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.

    PubMed 41302196

  • 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.

    PubMed 41546038

  • 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.

    PubMed 41340066

  • 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.

    PubMed 39080752

  • 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.

    PubMed 42552899

  • 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.

    PubMed 41220228

  • 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.

    PubMed 41248338

Questions about this trial

What is this clinical trial studying?

An observational study of Child Development and Early Child Development, run by New York University at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive Development (time frame: 1st of 3 visits at 36 months of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07758283, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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