Effectiveness of a cluster-randomised controlled trial of a culturally-embedded group music-making intervention (CHIME) to improve the mental health of pregnant women attending antenatal clinics in The Gambia, compared with usual care (waitlist control): a full cluster randomised controlled trial
Symptoms of common mental disorders (CMDs) in pregnancy
Intervention arm: Pregnant women in intervention clusters (n = 12) receive the CHIME intervention in addition to usual antenatal care. The CHIME intervention involves groups of up to 15 pregnant women meeting at their local antenatal clinic each week for 6 weeks. Sessions are led by trained Kanyeleng groups (traditional local women's community groups), who guide participants through structured participatory music activities drawing on traditional repertoire. Songs are adapted to emphasise key messages around psychological resilience, social support, and strategies for managing the physical and psychological challenges of pregnancy. One lullaby is introduced at each session for women to use after birth. Each session lasts approximately 60-90 minutes. The total intervention duration is six weeks, delivered during the antenatal period (approximately 12–27 weeks gestation). Control arm: Participants in control clusters (n = 12, potentially up to 15) receive usual antenatal care throughout the study period. After the final data collection point, control clusters receive a truncated version of the CHIME intervention (waitlist design). Randomisation: Following a mapping exercise to characterise all eligible health facilities, clinics are stratified by rurality and randomised to intervention or control by an external statistician. Clinic leads are notified individually of their allocation. Data collectors remain blinded to allocation throughout the study. Follow-up: Outcome data are collected at three time points: (1) baseline (prior to randomisation), (2) post-intervention (7 weeks post-randomisation), and (3) final follow-up at 6 months post-birth (when the infant is 6 months old).
1. Currently pregnant (12–27 weeks gestation) at time of recruitment 2. Aged 16 years or older 3. Speaks Mandinka 4. Attending an eligible antenatal clinic in Western Region 1, Western Region 2, or Upper River Region, The Gambia
1. Currently in severe crisis posing a risk to one's own or others' wellbeing 2. Experiencing current symptoms of psychosis Note: Participants meeting exclusion criteria will be referred to the community mental health team for appropriate care.