Cooper 2009.
| Study characteristics | |
| Methods |
Study design: RCT Duration of study: overall trial start 2000; overall trial end 2006 Country: South Africa Income classification: lower‐middle and upper‐middle‐income country between 2000 and 2006 Geographical scope: area of Khayelitsha (SST and Town II), a periurban settlement in Cape Town; SST is an informal settlement of shacks characterized by particularly high levels of unemployment and poverty; most shacks are without running water, and considerable overcrowding exists. Many of the inhabitants are recent migrants from rural parts of South Africa. Town II, into which SST merges, is characterized by a somewhat better standard of living. Healthcare setting: home of the participants |
| Participants | 1. Age: intervention group (n = 220), years (mean and SD): 25.2 (5.23). Control group (n = 229), years (mean and SD): 26.2 (5.84). 2. Gender: female 3. Socioeconomic background: not specified 4. Educational background: 28% in the intervention and 30% in control had received education for 6 years or less. Inclusion criteria: pregnant women within a defined area of Khayelitsha, a periurban settlement on the outskirts of Cape Town. Exclusion criteria: not specified. Note: at baseline, 16% of participants in the intervention and control group presented with depression as indicated by the Structured Clinical Interview for DSM‐IV diagnoses (SCID). Stated purpose: to assess the efficacy of an intervention designed to improve the mother‐infant relationship and security of infant attachment in a South African periurban settlement with marked adverse socioeconomic circumstances |
| Interventions |
Name: home‐visiting intervention Title/name of PW and number: lay community workers trained in intervention manual (4) 1. Selection: they had been selected with help from the local community council. They were mothers themselves. 2. Educational background: the women had no formal specialist qualifications. Two had completed schooling. 3. Training: they received training over a 4‐month period in basic parenting and counselling skills, as well as in the specific mother‐infant intervention. The home visitors received 3 weeks of training in the intervention over a 4‐month period and weekly group supervision from a community clinical psychologist. 4. Supervision: group supervision throughout the study, on a weekly basis, offering session by session supervision with an experienced community clinical psychologist 5. Incentives/remuneration: “We did not pay the women for their participation in the research, but at each assessment, we provided a small gift for the infant (an item of clothing).” Prevention type: indicated prevention – the study recruited in the last trimester of their pregnancy. At baseline, they presented some levels of distress (16% presenting with depression as indicated by the Structured Clinical Interview for DSM‐IV diagnoses). Intervention details: 16 visits home‐based (visited, ideally, twice antenatally, weekly for the first 8 weeks postpartum, fortnightly for a further 2 months, and then monthly for 2 months, 1‐h visits). The contents of mental health sessions are counselling and psychological secure attachment. The intervention was manualized. Control: usual care – women in the control group received the normal service provided by the local infant clinic. |
| Outcomes |
Participants’outcomes of interest for this review
Carers’ outcomes of interest for this review Nil Economic outcomes Nil Time points: baseline, post‐intervention (1‐6 months, 7‐24 months) |
| Notes |
Source of funding: this study was supported by a grant (B574100) from the Wellcome Trust. MT was supported by a fellowship from the Vlotman Trust. Notes on validation of instruments (screening and outcomes): the DSM‐IV interview had been translated and then back‐translated; the EPDS is widely adopted and validated across contexts (no specific reference to validation in South Africa is given in the study). Additional information: none Handling the data: not applicable Prospective trial registration number: ISRCTN25664149 |