Sanfilippo 2020.

Study characteristics
Methods	Study design: cluster‐RCT Duration of study: the study was conducted from November 2018 to May 2019. Country: The Gambia Income classification: low‐income country in 2018 Geographical scope: rural and urban as well as Wolof‐speaking and Mandinka‐speaking areas in The Gambia Healthcare setting: local antenatal clinics
Participants	1. Age: participants were between the ages of 18 and 40 (M = 26.95, SD = 5.72). 2. Gender: female 3. Socioeconomic background: not specified 4. Educational background: 50% of women received an informal education (Arabic); 31% secondary/tertiary education; 15% primary education; 4% no education. Inclusion criteria: All participants who a. were attending the consented sites during the active study period; b. were 18 or older; c. spoke either Mandinka or Wolof fluently; and d. were 14 to 24 weeks pregnant were invited to take part in the study. e. Participants were not preselected based on their mental health symptoms. Exclusion criteria: a. women with a history of a late‐term miscarriage; b. those who had a current or a history of psychosis. Note: at baseline, the intervention and control group scores for Edinburgh Postnatal Depression Scale (EPDS) were, respectively, 2.90 (3.07) and 5.16 (4.46). At baseline, the intervention and control group scores for Self‐Reporting Questionnaire‐20 (SRQ‐20) were, respectively, 6.22 (3.83) and 7.97 (3.99). Stated purpose: to test the feasibility of a Community Health Intervention through Musical Engagement (CHIME) to help reduce CMD symptoms in pregnant women compared with standard care. The study had five objectives—1) to obtain demographic information on the eligible population; 2) to determine if our measurement tools, the EPDS and the SRQ‐20, are useable; 3) to determine if the intervention is deliverable; 4) to determine if the stepped‐wedge trial design is deliverable and obtain information that will inform the definitive study; and 5) to determine if this type of intervention is culturally appropriate and well received by the community and health workers.
Interventions	Name: CHIME Title/name of PW and number: 4 local Kanyeleng groups (all‐female fertility societies, each composed of approximately 10 women) 1. Selection: each clinic also had an active local Kanyeleng group who could deliver the intervention. 2. Educational background: not specified 3. Training: training workshop held with the Kanyeleng groups before the intervention 4. Supervision: a community health nurse (CHN) at each clinic was present to observe, take attendance data and report any issues of concern to the research team including any potential adverse effects. 5. Incentives/remuneration: all participants were offered a total of 600 Dalasi (about US$12) for their time; 200 Dalasi (about US$4) at each data collection time point. Prevention type: selective—participants were included based upon the presence of a risk factor (pregnancy) and presented with some level of distress as indicated by EPDS scores that were below the cut‐off for the measure. Intervention details: CHIME draws on cognitive behavioural therapy principles from the Towards Parenthood and ACORN interventions. Participants in the CHIME intervention attended six 60‐minute music sessions held once a week over 6 weeks at their local antenatal clinic in addition to receiving standard antenatal care. Control: usual care (standard antenatal clinic care without any additional intervention. Standard care consists of four or more regular visits to the antenatal clinic with little to no mental healthcare).
Outcomes	Participants’outcomes of interest for this review Depressive symptoms – EPDS Distress/PTSD symptoms – SRQ‐20 Carers’ outcomes of interest for this review Nil Economic outcomes Nil Time points: baseline, post‐intervention (< 1 month; 1‐6 months)
Notes	Source of funding: MRC‐AHRC Global Public Health—Partnership Awards scheme (MR/R024618/1) awarded to Professor Lauren Stewart Notes on validation of instruments (screening and outcomes): “Both [questionnaires] were translated into Mandinka and Wolof. The translation method was based on suggestions from the WHO, Hanlon 2008 and Cox 2014. The EPDS has been validated for perinatal use in other African contexts, and used in The Gambia before, though a validated version could not be obtained.” Additional information: none Handling the data: not applicable Prospective trial registration number: Pan African Clinical Trials Registry (PACTR201901917619299)