NCT04252807

A Common Elements-based Intervention to Improve Maternal Psychological Well-being and Mother-infant Interaction

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Human Development Research Foundation, Pakistan · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Maternal Distress
• Perinatal Depression
• Development Delay
• Language Delay
• Cognitive Developmental Delay
• Nutrition Poor
• Growth Delay
• Motor Delay
• Maternal Behavior
• Infant Development
• Infant Malnutrition
• Infant Behavior

Interventions

Type	Name	Description
BEHAVIORAL	Intervention arm	In addition to the routine care delivered by Lady Health Workers (LHWs), the participants in the intervention arm will receive common elements based integrated intervention. The providers of the intervention are lay health workers who will be trained in the intervention using an online course. The lay health worker will complete the online training course in a group, with interactive group activities and role plays. Lay health workers will be supported online and in-person by the trainers in monthly supervision meetings. The lay health workers will deliver intervention to distressed mothers in 15 monthly sessions. The intervention consists of three modules including 1) mothers' well-being, 2) infant nutrition,early stimulation and breastfeeding and 3) mother-infant interaction.
OTHER	Treatment as Usual	The participants in the control arm will receive the routine visits by LHWs of their respective areas. The LHWs are trained to provide antenatal care and referral, immunization services and support to community mobilization, provision of family planning and basic curative care via door to door visits to the households of their allocated areas.

Timeline

• Start date: 2020-02-07
• Primary completion: 2021-10-31
• Completion: 2021-12-31
• First posted: 2020-02-05
• Last updated: 2022-08-03

Locations

1 site across 1 country: Pakistan