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

NCT05281575 | Unknown

• 2 other identifiers: FRGB2B-FR27FY21-A01-6024
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Psychosocial Functioning; Psychological Distress

Keywords

Psychosocial intervention; Refugees; Maternal health; Bangladesh

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (2)

• 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)

Other Outcomes (3)

• 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

Study Arms (2)

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.

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.

Behavioral: Baby Friendly Spaces (BFS)

Interventions

Baby Friendly Spaces (BFS) 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; Treatment as Usual BFS (TAU BFS)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Action Contre la Faim: lead
• Johns Hopkins Bloomberg School of Public Health: collaborator
• University of Virginia: collaborator
• University Research Co, LLC: collaborator

Study Sites (1)

Action Against Hunger

Cox’s Bāzār, Bangladesh

Location

Study Officials

• Karine LE ROCH, PhD

  Action Contre la Faim

  PRINCIPAL INVESTIGATOR

• Sarah MURRAY, PhD

  Jonhs Hopkins University

  PRINCIPAL INVESTIGATOR

• Amanda NGUYEN, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 16, 2022
• Study Start: November 28, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Beginning six months after publication of summary data, to remain available until USAID determines removal from Developmental Data Library.

Locations

BA (1)