Common elements-based nurturing care intervention to improve mother-infant responsive interaction and maternal psychological wellbeing in rural Pakistan: findings of a single-blinded individual randomised controlled trial

OBJECTIVES: To evaluate the effectiveness of a common elements–based Nurturing Care for Early Child Development Intervention delivered by non-specialists in improving mother–infant responsive interaction at 12 months postpartum among pregnant women experiencing psychological distress in rural Pakistan. DESIGN: Two-arm, single-blinded, individually randomised controlled trial. SETTING: Community-based primary care settings in a rural sub-district of Rawalpindi, Pakistan. PARTICIPANTS: Pregnant women in their third trimester aged 18–40 years who screened positive for psychological distress (Self-Reporting Questionnaire score ≥9). Of 1962 women assessed for eligibility, 250 were enrolled and randomised to the intervention (n=125) or treatment-as-usual (TAU) arm (n=125). INTERVENTIONS: Participants in the intervention arm received 15 monthly individual sessions of a Nurturing Care for Early Child Development intervention delivered by trained non-specialist facilitators from the third trimester of pregnancy until 12 months postpartum. The intervention included early stimulation, learning through play, responsive feeding, guided discovery using pictures, behavioural activation and problem-solving. Participants in the control arm received routine maternal and child health services (treatment as usual). PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was caregiver–infant responsive interaction measured using the Observation of Mother–Child Interaction (OMCI) at 12 months postpartum. Secondary outcomes included maternal psychological well-being, quality of life, functioning and perceived social support, as well as infant growth including birth weight, nutrition, cognitive development and socio-emotional development. Data were collected at baseline (third trimester), 6 months and 12 months postpartum. Endpoint assessments were delayed by 2 months due to COVID-19 lockdown restrictions. RESULTS: Of the 250 participants randomised, 206 completed the 12-month follow-up assessment. At the endpoint, mother–infant dyads in the intervention arm demonstrated significantly higher OMCI total scores compared with TAU (mean (SD) 42.05 (8.65) vs 29.74 (8.19); adjusted mean difference 12.31, 95% CI 9.99 to 14.62; p<0.0001). As a secondary outcome, infants in the intervention arm had higher birth weight (mean difference 0.78 kg, 95% CI 0.30 to 1.25; p<0.001). Improvements were also observed in infant cognitive and socio-emotional development and maternal psychological well-being, functioning and quality of life. CONCLUSIONS: A common element–based nurturing care intervention delivered by trained non-specialists improved mother–infant responsive interaction among infants of mothers experiencing psychological distress. TRIAL REGISTRATION NUMBER: NCT04252807.