Psychosocial FunctioningNCT05281575
Evaluation of Baby Friendly Spaces in Cox's Bazar, Bangladesh.
A study testing Baby Friendly Spaces (BFS) in people with Psychosocial Functioning and Psychological Distress, run by Action Contre la Faim at 1 site in Bangladesh.
Trial 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 Cox's Bazar, Bangladesh. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychosocial Functioning, Psychological Distress
- What is being tested?
- Baby Friendly Spaces (BFS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteBangladesh
- Study dates
- 28 Nov 2021to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Psychosocial Impacts of Baby Friendly Spaces for Rohingya Refugee Mothers Living in Cox's Bazar, Bangladesh.
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.
Read the 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 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
- Psychosocial Functioning, Psychological Distress
- Being tested
- Baby Friendly Spaces (BFS)
- Keywords
- Psychosocial intervention, Refugees, Maternal health, Bangladesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby Friendly Spaces (BFS)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual BFS (TAU BFS) | Active comparator | 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. Receives: Behavioral: Baby Friendly Spaces (BFS) |
| Enhanced BFS | Experimental | 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. Receives: Behavioral: Baby Friendly Spaces (BFS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (pre), 8 weeks (post)
Secondary outcomes (2)
Subjective Well-Being by the Personal Well-being Index-Adult (PWI-A)
The Personal Well-being Index-Adult (PWI-A) assesses satisfaction with specific life domains, e.g., health, safety, personal relationships etc. Each item is rated on a likert scale from 0 (no satisfaction at all) to 10 (very satisfied). Change scores will be calculated for both overall wellbeing as well as domain-specific wellbeing. Scored between 0- 100. Higher scores indicate greater satisfaction.
Measured: Baseline (pre), 8 weeks (post)
Coping styles by the Brief COPE
Coping styles will be assessed using an adapted version of the Brief COPE (26 items) that includes addition of items previously generated from qualitative study in this population as well as removal of items identified during pre-testing to be redundant, irrelevant, or difficult-to-understand. the scale defines the primary copng style among three coping styles. Scored between 0-78. The higher score indicate higher engagement in a coping style.
Measured: Baseline (pre), 8 weeks (post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start28 Nov 2021
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial FunctioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Action Contre la Faim
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins Bloomberg School of Public Health, University of Virginia, University Research Co, LLC
- Responsible party
- Sponsor
- Investigators
- Karine LE ROCH, PhD, Principal investigator, Action Contre la FaimSarah MURRAY, PhD, Principal investigator, Jonhs Hopkins UniversityAmanda NGUYEN, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281575
- Sponsor's protocol ID
- FRGB2B-FR27
- Other IDs
- FY21-A01-6024
- Status last verified
- Mar 2022
- First submitted
- 9 Feb 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified quantitative survey data will be shared in USAID's Developmental Data Library
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Psychosocial Impacts of Baby Friendly Spaces for Rohingya Refugee Mothers Living in Cox's Bazar, Bangladesh.
- ClinicalTrials.gov ID
- NCT05281575
- Acronym / sponsor ID
- FRGB2B-FR27
- Conditions
- Psychosocial Functioning, Psychological Distress
- Keywords
- Psychosocial intervention, Refugees, Maternal health, Bangladesh
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Action Contre la FaimUniversity, hospital or other
- Collaborators
- Johns Hopkins Bloomberg School of Public Health, University of Virginia, University Research Co, LLC
- Study start
- 28 Nov 2021 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual BFS (TAU BFS) | Active comparator | Behavioral: Baby Friendly Spaces (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. |
| Enhanced BFS | Experimental | Behavioral: Baby Friendly Spaces (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Enhanced BFS, Treatment as Usual BFS (TAU BFS) |
Primary outcome
Symptoms of psychological distress by a combined IDSS and K-6
Time frame: Baseline (pre), 8 weeks (post)
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.
Functional Impairment by the WHO Disability Assessment Schedule 2.0 (WHODAS)
Time frame: Baseline (pre), 8 weeks (post)
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.
2 secondary outcomes
Subjective Well-Being by the Personal Well-being Index-Adult (PWI-A)
Time frame: Baseline (pre), 8 weeks (post)
Coping styles by the Brief COPE
Time frame: Baseline (pre), 8 weeks (post)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: Yes. De-identified quantitative survey data will be shared in USAID's Developmental Data Library
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karine LE ROCH, PhD principal investigator
Action Contre la Faim
Sarah MURRAY, PhD principal investigator
Jonhs Hopkins University
Amanda NGUYEN, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby Friendly Spaces (BFS) in people with Psychosocial Functioning and Psychological Distress, run by Action Contre la Faim 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 3 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: status not confirmed, as of the sponsor's last update on 16 Mar 2022. 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?
Results are not available in the source record.
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?
Symptoms of psychological distress by a combined IDSS and K-6 (time frame: Baseline (pre), 8 weeks (post)). 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?
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 16 Mar 2022.