Evaluation of Baby Friendly Spaces in Cox's Bazar, Bangladesh.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-28

Study Completion Date

2022-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Strengthening Bangladeshi Babies Brains (SBBB)

NCT04093934

Child Development

UNKNOWN NA

Effects of Psychosocial Stimulation and Cash on Children's Development and Behaviour

NCT03281980

Child Development Child Behavior

UNKNOWN NA

Evaluation of the Effects of Community-based Interventions

NCT00198731

Pregnancy

COMPLETED

Community Based Interventions to Reduce Neonatal Mortality in Bangladesh

NCT00198705

Infectious Disease

COMPLETED NA

Enhancing Safe Sleep Practices of Urban Low-Income Mothers

NCT03070639

Sudden Infant Death Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Action contre la Faim (ACF) currently provides psychosocial support services to Rohingya mothers of malnourished children who are receiving nutrition support at Integrated Nutrition Centers (INCs) within refugee camps in Cox's Bazar, Bangladesh. At the INCs, the Baby Friendly Spaces (BFS) program is offered as a part of ACF's psychosocial and care practices support strategy. The BFS program is a holistic psychosocial support program designed to enhance mothers' wellbeing in order to buffer against the deleterious health and developmental impacts of conflict and disaster on children. BFS is designed to be flexible to meet the unique needs of different conflict-affected populations using a community-based approach, but always focuses 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 to positively impact the nutritional status and wellbeing of their children during humanitarian emergencies. The purpose of this study is to evaluate the effectiveness of the BFS program for improving the psychosocial wellbeing of Rohingya refugee mothers of young (ages 0-2) children experiencing malnutrition in Cox's Bazar, Bangladesh.

As they are currently functioning, BFS activities in Cox's Bazar are not standardized as intended. Thus, this study will use a pre-post, paired randomized study design to compare two conditions being delivered within Integrated Nutrition Centres (INCs) in Cox's Bazar-based refugee camps: 1) treatment-as-usual BFS mental health and psychosocial support prevention and promotion activities (TAU BFS) as they are currently being offered; and 2) implementation-enhanced BFS activities (enhanced-BFS) that includes intervention standardization, re-training, and implementation supports. The primary outcomes being evaluated are symptoms of psychological distress and functional impairment, and secondary outcomes include subjective maternal wellbeing and coping skills. Although a randomized controlled trial (RCT) comparing BFS against a non-active control condition would provide the clearest evidence, such a design is not feasible in this context because the services are already being offered as a part of existing programming, and removal of any existing supports would be unethical. As such, the proposed study design uses current BFS practices occurring in Integrated Nutrition Centers (INCs) that have not been manipulated as part of the research (treatment as usual). These services are not manualized and have been affected by natural drifts in fidelity over time since initial training. In the intervention condition, psychosocial workers and psychologists at select INCs will be re-trained in a manualized version of the BFS program, and will continue to receive additional implementation support during the study through newly established supervision structures (enhanced-BFS).

As the experimental manipulation is occurring at the INC-level, INCs were paired by overseeing psychologist (as in some cases one psychologist oversees two sites) and randomize within the pair to intervention (BFS-enhanced) or treatment as usual control (BFS TAU). In addition to incorporating site matching in the design phase to help try to minimize bias in group comparisons while assessing the intervention as implemented in the real world, propensity score adjustments in the analysis approach will be leveraged. After completing the BFS intake, eligible and interested mothers are referred to a data collector to obtain informed consent and administer a baseline interview. Mothers can then participate in BFS to whatever extent they choose. The same data collector will follow up with each mother 8-10 weeks later to complete a follow-up interview. Because of logistical constraints, each INC has been assigned a single data collector to carry out study activities at that site. All sites will also record detailed information (as part of regular program monitoring) about activities delivered and received by women enrolled in BFS at the INCs. Two trained observers will rotate through the INCs to record fidelity data. This real-world comparison of an intervention implemented "as is" versus an enhanced program implemented with effort towards greater standardization and fidelity will provide insight about effectiveness of the program model and structures and resources that need to be in place to effectively implement the program.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psychosocial Functioning Psychological Distress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

The co-PIs are masked, as are data analysts. The participants have not been told what arm of the trial they are in, and outcome assessors assigned to integrated nutrition centers have not been told if that center was re-trained or not, though it is conceivable that they could deduce this information.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment as Usual BFS (TAU BFS)

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.

Group Type ACTIVE_COMPARATOR

Baby Friendly Spaces (BFS)

Intervention Type BEHAVIORAL

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).

Enhanced BFS

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.

Group Type EXPERIMENTAL

Baby Friendly Spaces (BFS)

Intervention Type BEHAVIORAL

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Baby Friendly Spaces (BFS)

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult (aged 18 or older) Rohingya women enrolling for the first time in BFS services at a participating integrated nutrition center (INC)
* The mother of a child under age 2 who is identified as suffering from moderate or severe acute malnutrition without complication by ACF
* Able to speak and understand Chittagonian dialect of Bangla

Exclusion Criteria

* Target child has a severe developmental disability or is severely malnourished with complications
* Maternal cognitive impairment or psychosis that would preclude participation in program activities
* Referred per standard program practice to more specialized mental health or protection services outside of Action Contre la Faim (ACF)
* Planning to leave the area in the next 2 months

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes