Evaluating the Impact of a Common Elements-based Intervention to Improve Maternal Psychological Well-being and Mother-infant Interaction in a Low Resource Community Setting of Rural Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Observation of Mother and Child Interaction Tool (OMCI)
研究概览
简要总结
Background: Millions of children in low resource settings are at high risk of poor development due to factors such as undernutrition, inadequate stimulation and maternal depression. Evidence based interventions to address these risk factors exist, but often as a separate and overlapping packages delivered through disjointed systems, therefore posing problems in scale-up. A common elements approach based intervention that combines evidence-based elements from packages of care addressing early stimulation, responsive feeding and maternal distress have been developed.
Objectives: The current study aims to develop an online training curriculum to train lay health workers in common elements based intervention to improve maternal psychological well-being and improve mother-infant interaction among distressed mothers in low resource rural community settings of Pakistan. The impact of intervention on maternal well-being, infant growth, nutrition and development will be evaluated at 12-months post-partum.
Method: A two arm, single blind, individual randomized controlled trial (RCT) will be carried out in the community settings of the rural sub-district of Gujar Khan in Rawalpindi, Pakistan. 250 Pregnant women in third trimester of pregnancy, screened positive for psychological distress on Self-Reporting Questionnaire (SRQ), cut-off score ≥ 9, will be randomized on 1:1 allocation ratio into intervention (n=125) and Treatment as Usual (TAU) arms (n=125). The participants in the intervention arm will receive 15 monthly sessions of intervention by community volunteers at home. First three sessions will be delivered in the third trimester of pregnancy followed by one monthly session for 12 months. The primary outcome will be caregiver-infant interaction at 12-months post-partum. The maternal secondary outcomes include maternal psychological wellbeing, quality of life, social support and empowerment. Maternal outcomes will be measured at baseline, 6-months and 12-months post-partum. Infant secondary outcomes include growth, nutrition and development and will be measured at 12 months. A mixed-methods process monitoring and evaluation will be conducted to inform the feasibility of intervention delivery.
Discussion: The outcomes of the study will be a common-elements based online training curriculum for training of community volunteers in intervention to improve maternal psychological well-being and mother-infant interaction in low resource rural community settings at-scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Study investigators and outcome assessors will be blind to the allocations status of participants. To ensure blinding, participants will be instructed to not disclose their allocation during assessment.
Fidelity of masking will be ensured by having assessors guess the allocation status of participants at the end of assessments.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant with third trimester (28 gestational week)
- •Age 18-40 years
- •Intent to reside in the study areas until the completion of the study
- •Score ≥9 on the SRQ
排除标准
- •Women who require immediate or on-going medical or psychiatric care reported.
- •Severe previous or current obstetric morbidity including eclampsia and antepartum hemorrhage;
- •Medical disorders that require inpatient management (e.g., diabetes, hypertension, thromboembolism, cardiac disease)
结局指标
主要结局
Observation of Mother and Child Interaction Tool (OMCI)
时间窗: At 12-months postpartum
Maternal responsive caregiving behaviours will be assessed using the Observation of Mother and Child Interaction (OMCI) tool . OMCI tool is based on responsive parenting framework proposed by Landry and colleagues. The research assistants will observe a live 5-minute mother-infant interaction while mother and infant will play together with a picture book. The tool comprises of 19 items covering maternal affect, maternal touch, maternal verbalization, sensitivity and contingent responses, scaffolding, language stimulation, focus, child affect, child focus, child's communication efforts, and mutual enjoyment. The scoring format is based on the frequency of the occurrence of behaviours with higher scores indicating more responsive interactions. The OMCI tool has been validated for use in similar population in Pakistan.
次要结局
- Ages and Stages Questionnaire 3rd Edition (ASQ3)(At 12-months postpartum)
- The Home Observation for Measurement of the Environment Scale (HOME)(At 12-months postpartum)
- Anthropometric measurements(At 12-months postpartum)
- Early breastfeeding (EBF) scale(At 6-months postpartum)
- Number of diarrhoeal episodes(At 6 and 12-months postpartum)
- Immunization record form(At 6 and 12-months postpartum)
- Self-Reporting Questionnaire (SRQ)(At baseline, 6 and 12-months postpartum)
- Bayley's Scales of Infant Development (BSID III)(At 12-months postpartum)
- Pediatric Quality of Life Inventory (PedsQL)(At baseline and 12-months postpartum)
- Multi-Dimensional Scale of Perceived Social Support (MSPSS)(At baseline and 12-months postpartum)
- World Health Organization Disability Assessment Schedule (WHODAS-12)(At baseline and 12-months' post-partum)
- Maternal Financial Empowerment Scale(At baseline and 12-months' post-partum)
- Client Service Receipt Inventory (CSRI)(At baseline and 12-months postpartum)