**Background:**
Early childhood development (ECD) is critical, with an estimated 250 million children (43%) under 5 in low-and-middle-income countries at risk of not meeting developmental potential. The first 1000 days are a highly sensitive period for optimising development. WHO guidelines for improving ECD emphasise integrating nutrition and caregiving, promoting early learning, supporting maternal mental health, and responsive caregiving. In South Africa, only 32% of infants under 6 months are exclusively breastfed, with mean exclusive breastfeeding duration of 2.9 months. Up to 57% of South African mothers present with postnatal depression symptoms. Maternal self-efficacy is a key contributor to responsive caregiving and is influenced by health literacy, social support, and mental health. Behavioural feedback—comparing individual behaviour to a standard—is an effective component of parenting interventions. The PLAY Study was designed to test a multicomponent intervention addressing these gaps in Soweto, an urban-poor area of Johannesburg with over 1.3 million people.
**Methods:**
This phase 1 randomised controlled trial will recruit 210 mother–infant pairs within 3–10 days of delivery from community clinics in Soweto. Inclusion criteria: mothers ≥18 years, primary caregiver, residing in Soweto and planning to remain for study duration. Participants are individually randomised 1:1 to intervention or standard of care arms using simple randomisation generated by Stata V.17. Expected attrition is 30%, yielding a final sample of 150 (75 per group). Data collection teams are blinded to randomisation at baseline and primary outcome assessments; separate teams collect baseline vs. primary outcome data. The intervention runs from birth to 12 months, with assessments at 0, 6, and 12 months.
The standard of care arm receives the Road to Health booklet, Side-by-Side services, telephonic/in-person check-ins every 2 months with referrals, and measurements every 4 months. The intervention arm additionally receives: (1) Newborn Behavioural Assessment (NBO) at recruitment with feedback and anticipatory guidance; (2) rapid behavioural feedback every 4 months via app and in person on infant movement behaviours (graphical representation) and mother–infant interaction styles (video feedback guided by VIPP-SD); (3) mental health screening at recruitment and 4 months using EPDS, PCL-5, ACE Scale, and ASQ, with high-risk women receiving individual counselling from a licensed psychologist and referral; (4) weekly health literacy content via the PLAY Study mobile app; (5) telephonic/in-person conversations every 2 months following key themes. Content focuses on: exclusive breastfeeding (0–6 months), interactive play and early learning (6–12 months), and responsive caregiving and maternal mental health (0–12 months). The intervention is delivered by community health helpers trained by the study team, supported by a supervisor with referral network access.
The primary outcome is maternal self-efficacy at 12 months assessed by the Perceived Maternal Parenting Self-Efficacy Tool (Cronbach's Alpha 0.95 in Soweto pilot). Secondary outcomes include: infant development at 12 months (ASQ3), breastfeeding self-efficacy (Breastfeeding Self-Efficacy Short Form every 2 months), exclusive breastfeeding (maternal report every 2 months), feasibility and acceptability (Theoretical Framework of Acceptability questionnaires and focus groups), weight-to-length ratio, fat mass index (DXA at 12 months), maternal health literacy (Health Literacy Questionnaire), maternal mental health (PCL-5, EPDS, ACE, ASQ, Postpartum Bonding Questionnaire), infant movement behaviours (7-day 24-hour wrist-worn accelerometry every 4 months), and mother–infant interaction styles (headcam video observation every 4 months).
Sample size of 150 (75 per group) provides 99% power to detect efficacy based on maternal self-efficacy pilot data. Analysis will use intention-to-treat; secondary outcomes compared with Student's unpaired t-tests, presented with point estimates and 95% CI. A Community Advisory Group (n=16 mothers, n=8 family matriarchs) will advise on content, delivery, and retention throughout the trial.
**Key Results:**
This is a protocol paper; no results are reported. The trial was registered on 10 February 2022 (PACTR202202747620052), recruitment planned from Q3 2022 to Q2 2023, with completion expected Q2 2024.
**Clinical Implications:**
If found feasible and acceptable, the intervention could be implemented at scale within primary healthcare services and linked with existing digital solutions like MomConnect in South Africa. The PLAY Study app could be developed into an accessible resource for all mothers. The content aligns with the Nurturing Care Framework and WHO guidelines, making it relevant at national and international policy levels. The behavioural feedback components (accelerometry and headcam assessments) are more resource-intensive and would require additional funding and training for scaling. The study is limited by reliance on cell phone/computer access, though mitigation strategies include making the app data-free and available on multiple platforms. Findings are specific to socioeconomically disadvantaged mothers in Soweto and cannot be extrapolated to higher-income settings or different populations. Fathers are not included due to low prevalence of caregiving fathers in this context.