NCT04252807.

Study name	A common elements‐based intervention to improve maternal psychological well‐being and mother‐infant interaction
Methods	Study design: RCT Country: Pakistan
Participants	Distressed pregnant women Inclusion criteria:  a. pregnant with third trimester (28 gestational weeks); b. aged 18‐40 years; c. intent to reside in the study areas until the completion of the study; d. score ≥ 9 on the SRQ. Exclusion criteria: a. women who require immediate or ongoing medical or psychiatric care reported; b. severe previous or current obstetric morbidity including eclampsia and antepartum haemorrhage; c. medical disorders that require inpatient management (e.g. diabetes, hypertension, thromboembolism, cardiac disease). Stated purpose: 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 amongst 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' postpartum.
Interventions	Intervention: Common elements based integrated intervention 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 that combines evidence‐based elements from packages of care addressing early stimulation, responsive feeding and perinatal depression. The participants will receive 15 monthly sessions at home by lay health workers. First three sessions will be delivered to the participants in the third trimester of pregnancy, followed by 12 monthly sessions afterwards. The intervention consists of three modules including 1) mothers' well‐being, 2) infant nutrition, early stimulation and breastfeeding and 3) mother‐infant interaction. Control: Usual care (the participants in the control arm will receive the routine monthly visits by the trained lady health workers (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).
Outcomes	Participants'outcomes of interest for this review Mental health symptoms/distress/PTSD – Self‐Reporting Questionnaire (SRQ) Quality of life – Pediatric Quality of Life Inventory (PedsQL) Social outcomes (perceived social support) – Multi‐Dimensional Scale of Perceived Social Support (MSPSS) Psychological functioning and impairment – World Health Organization Disability Assessment Schedule (WHODAS‐12) Economic outcomes Nil Time points: baseline, post‐intervention (12 months postpartum; for depression also 6 months postpartum)
Starting date	7 February 2020
Contact information	Syed Usman Hamdani
Notes	Source of funding: no clear specification for funding Prospective trial registration number: NCT04252807