Khan 2018.

Study characteristics
Methods	Study design: cluster‐RCT Duration of study: the study was conducted between 2014 and 2016. Country: Pakistan Income classification: lower‐middle‐income country in 2014‐2016 Geographical scope: urban; “poor urban localities”, “metropolitan districts of Lahore and Rawalpindi” Healthcare setting: primary care facilities, private general practitioner's clinics
Participants	1. Age: at baseline mother mean age: 27.1; child mean age 9.7/15.9 days 2. Gender: female for caregivers, children both 3. Socioeconomic background: not specified 4. Educational background: mean education years in intervention group 8.3 (±3.9), in control 8.6 (±3.8) Inclusion criteria—clinic: a. relative maximum number of years’ establishment; b. higher patient load; c. availability of maternal and child health care. Inclusion criteria—mother/child dyad Each (self or peer‐referred) mother visiting the clinic with a child aged < 40 days was assessed by the clinic assistant for inclusion eligibility based on: a. the child being 2.5 kg at birth; b. free of congenital abnormalities; c. without a history of delayed cry at birth and/or seizures. Exclusion criteria: none reported. Note: considerations on baseline scores not applicable for this study Stated purpose: to assess the effectiveness of delivering a contextualized early child development (ECD) mother‐counselling intervention.
Interventions	Name: Integrated Early Child Development package Title/name of PW and number: clinic assistants (32) and general practitioners (32) 1. Selection: from 32 poor union councils: “Private clinics in the selected union councils were mapped, and two clinics in each union council were shortlisted based on relative maximum number of years’ establishment, higher patient load, and availability of maternal and child health care.” 2. Educational background: general practitioners standard training; clinical assistant “usually a local male, with 10–12 years of schooling but no formal paramedic training”. 3. Training: “Clinic assistants trained on: 1) conduct of structured counselling session using the flip‐book; 2) administration of the first two questions of the Patient Health Questionnaire‐9 (known as PHQ‐2); 3) measurement and recording of child length and weight ‐ Private GPs trained on: 1) clinical management of children with malnutrition and developmental delay in the private clinic setting and specialist referral; 2) diagnosis of maternal depression PHQ‐9”; “Training will last approximately 2 hours, and will include a mixture of explanation by the project field coordinator, and role‐play exercises by participants.” 4. Supervision: from author correspondence: monitoring was done for record‐keeping only. 5. Incentives/remuneration: not specified Prevention type: universal – all mothers with a child aged 40+ days were eligible for inclusion. Intervention details: intervention focused on quarterly counselling of mothers via a specifically designed flip‐book. The tool‐assisted counselling supplements the mother’s ability to promote age‐appropriate activities for ECD and improved child nutrition and to manage her own depression. The contents of each counselling session were designed to take ≤ 10 minutes. The registered mother‐child pairs were required to visit the clinic every 3 months to get assessed and counselled by the clinic assistant, when the child was aged 3, 6, and 9 months. Control: usual care – the current mother‐child care at a private clinic is curative‐oriented (that is, responding to an ailment) rather than health promotion‐oriented. In ECD care, the private clinics do not provide any child development counselling, instead of responding to any complaint that is reported or noted.
Outcomes	Participants’outcomes of interest for this review Depressive symptoms – Patient Health Questionnaire (PHQ‐9) Carers’ outcomes of interest for this review Nil Economic outcomes Nil Time points: baseline, post‐intervention (7‐24 months) Note: data were not included in the meta‐analysis because they were not provided in the right format or were not available even after attempted author contact.
Notes	Source of funding: the project was funded by Grand Challenge Canada, Saving Brains, and was implemented by the Association for Social Development, Pakistan (Ref. No. 0585‐03). Notes on validation of instruments (screening and outcomes): the PHQ‐9 is a widely adopted and validated tool. Additional information: none Handling the data: not applicable Prospective trial registration number: not available