Ignite Creation Date:
2024-05-06 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05281575
Status:
UNKNOWN
Last Update Posted:
2022-03-16
First Post:
2022-02-09
Brief Title:
Evaluation of Baby Friendly Spaces in Coxs Bazar Bangladesh
Sponsor:
Action Contre la Faim
Organization:
Action Contre la Faim
Study Overview
Official Title:
Evaluation of the Psychosocial Impacts of Baby Friendly Spaces for Rohingya Refugee Mothers Living in Coxs Bazar Bangladesh
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Coxs 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 Coxs 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
Detailed Description:
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 Coxs Bazar Bangladesh At the INCs the Baby Friendly Spaces BFS program is offered as a part of ACFs 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 Coxs Bazar Bangladesh
As they are currently functioning BFS activities in Coxs 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 Coxs 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
As they are currently functioning BFS activities in Coxs 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 Coxs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FY21-A01-6024 | OTHER_GRANT | University Research Co LLC | None |