NCT05281575|Unknown
Evaluation of Baby Friendly Spaces in Cox's Bazar, Bangladesh.
Evaluation of the Psychosocial Impacts of Baby Friendly Spaces for Rohingya Refugee Mothers Living in Cox's Bazar, Bangladesh.
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Evaluation of the Psychosocial Impacts of Baby Friendly Spaces for Rohingya Refugee Mothers Living in Cox's Bazar, Bangladesh.
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · University Research Co., LLC
interventional
600
1 country
1
Study Start
November 28, 2021
Actual (reported)Primary Completion
March 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The overarching goal of this study is to evaluate the effectiveness and implementation of the Baby Friendly Spaces (BFS) program for improvement of maternal psychosocial wellbeing among Rohingya refugee mothers and their malnourished infants and young children in Cox's Bazar, Bangladesh. The purpose of the BFS program is to provide convenient, accessible psychosocial support to mothers in order to facilitate their ability to care for their children. BFS activities include: counselling for infant and young child feeding practices, hygiene education and promotion, group discussions on parenting skills, mother-child bonding activities and maternal psychosocial support. In Cox's Bazar, the BFS program is not currently standardized as intended. In this study, integrated nutrition centers that offer the BFS program are being paired and randomized to receive re-training in a standardized and implementation-enhanced version of BFS (enhanced-BFS) or to continue BFS services as usual (TAU-BFS). Primary (symptoms of psychological distress and functional impairment) and secondary (subjective psychosocial wellbeing and coping) outcomes will be assessed immediately post intervention (8 weeks after initial baseline assessment) via interviewer-administered surveys. The central hypothesis is that mothers attending enhanced-BFS services will experience greater improvement in all psychosocial well-being indicators relative to mothers in the standard, treatment-as-usual centers.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 28, 2021
Actual (reported)February 9, 2022
Actual (reported)March 16, 2022
Actual (reported)March 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Symptoms of psychological distress by a combined IDSS and K-6
Change in mean score on an adapted psychological distress scale comprised of items from the Myanmar-wide version of the International Depression Symptom Scale (IDSS) questionnaire as well as the Kessler-6. Together, these items assess common indicators of psychological distress including symptoms of depression, anxiety, and somatic complaints. Prior to generating scale scores, baseline data will be used to examine the scale's psychometric properties including factor structure and internal consistency, and will remove any problematic items. Higher scores indicate greater symptom severity.
Baseline (pre), 8 weeks (post)
Functional Impairment by the WHO Disability Assessment Schedule 2.0 (WHODAS)
Change in mean score of the WHODAS 2.0 questionnaire assessing six domains of functioning: cognition, mobility, self-care, getting along/social interactions, life activities, and participation. Each item is coded either "none", "mild", "moderate", "severe" and "extreme". The total score ranges between 0 and 60. Higher scores indicate greater disability severity.
Baseline (pre), 8 weeks (post)
Subjective Well-Being by the Personal Well-being Index-Adult (PWI-A)
Baseline (pre), 8 weeks (post)
Coping styles by the Brief COPE
Baseline (pre), 8 weeks (post)
Qualify of caregiving practices
Baseline (pre), 8 weeks (post)
Implementation outcomes
8 week follow-up
Child growth and development by the WHO Gross motor development milestones
8 week follow-up
Continuation of existing Baby Friendly Spaces program activities in integrated nutrition centers, which are not manualized and without re-training have naturally drifted in fidelity to the intervention and supervision approach due to time since initial training.
The implementation-enhanced BFS intervention includes re-training using newly developed training materials that focus on building core therapeutic engagement skills. Ongoing supports include brief guidance sheets for each of the most commonly delivered BFS activities, as well as newly established group supervision focused on BFS, discussion facilitation, activities and self-care.
Designed to meet the unique needs of populations living in humanitarian contexts, BFS focus on two domains: psychosocial support that targets maternal wellbeing and childcare practices that target caregiver functioning to also address child wellbeing and development. In so doing, BFS strengthens mothers' internal resources and skills in caring for their children both in quantity (time spent caring for the child) and quality (responsiveness), to positively impact the health status and wellbeing of their children. In BFS, the following activities are delivered by trained psychosocial workers: counselling for infant and young child feeding practices; hygiene education and promotion; mother-child bonding activities that provide psychosocial stimulation essential for children at risk of, or experiencing, malnutrition; and provision of maternal psychosocial support (i.e. psychoeducation, stress management).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Action Against Hunger
Cox’s Bāzār, Bangladesh
Karine LE ROCH, PhD
Action Contre la Faim
Sarah MURRAY, PhD
Jonhs Hopkins University
Amanda NGUYEN, PhD
University of Virginia
600 participants (actual enrollment reported by the registry).
First Submitted
February 9, 2022
First Posted
March 16, 2022
Study Start
Contact the study team to confirm eligibility.
November 28, 2021
Primary Completion
March 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 16, 2022
Record last verified: 2022-03
De-identified quantitative survey data will be shared in USAID's Developmental Data Library
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