Langer 1996.

Study characteristics
Methods	Study design: RCT Duration of study: not specified Country: Brazil, Cuba, Argentina, Mexico Income classification: Brazil, Argentina, and Mexico upper‐middle‐income, Cuba low‐middle from 1990 to 1996 (year of study publication) Geographical scope: cities of Rosario (Argentina), Pelotas (Brazil), La Habana (Cuba), and Mexico City (Mexico) Healthcare setting: participants’ homes
Participants	1. Age: intervention 24.3 (6.6); control 24.6 (6.6) 2. Gender: female 3. Socioeconomic background: 55.1% in the intervention and 54.9% in control groups had low family incomes. 4. Educational background: schooling years in intervention 8.4 (3.7), in control 8.4 (3.8) Inclusion criteria: Women who were: a. attending the antenatal clinics in the four participating centres between the 15th and the 22nd week of gestation with singleton pregnancies; b. presenting at least one of the following factors: previous low birth weight, stillbirth or infant death; age under 18 years; weight under 50 kg; height under 150 cm; overcrowding; smoking; low family income (according to locally defined cut‐offs); schooling of less than 3 years; lack of husband or partner. Exclusion criteria: presenting chronic conditions that might interfere with pregnancy and require special care. Note: at baseline, the intervention and control group scores for the Spielberger State‐Trait Anxiety‐Inventory (STAI) were, respectively, 39.3 (12.3) and 39.1 (12.5). Stated purpose: to evaluate a psychosocial support intervention during pregnancy aimed at improving perinatal health and mothers' psychosocial conditions
Interventions	Name: psychosocial support Title/name of PW and number: home visitors (not specified) 1. Selection: female social workers or obstetric nurses 2. Educational background: background in social work or obstetric nursing 3. Training: 33 months before the intervention the home visitors received a special training course; they also received an operational manual. 4. Supervision: not specified 5. Incentives/remuneration: not specified Prevention type: selective—including all pregnant women with 1+ risk factor. Prevention type: selective—participants were pregnant women included based upon the presence of a risk factor. They also presented with some level of distress as indicated by STAI scores that were below the cut‐off for the measure. Intervention details: the intervention was aimed at increasing social support and reducing stress and anxiety. Its core was four home visits delivered at approximately the 22nd, 26th, 30th, and 34th weeks of gestation. The number of visits could be increased up to six when considered needed. The psychosocial support programme had four main components: (a) reinforcement of social support network; (b) provision of emotional support; (e) improvement of knowledge about pregnancy and delivery; (d) reinforcement of adequate health services utilization. The pregnant woman, the visitor, and a so‐called ‘support person’ participated in the home visits. This ‘support person’ (husband/partner, mother, sister, friend or neighbour) was selected by the patient to share with her intervention activities and was strongly encouraged to be involved throughout the pregnancy, helping the woman to solve problems, promote healthy behaviours and prenatal care attendance. Control: usual care – the control group received the routine antenatal care available at each of the participating institutions.
Outcomes	Participants’outcomes of interest for this review Anxiety symptoms – STAI Carers’ outcomes of interest for this review Nil Economic outcomes Nil Time points: baseline, post‐intervention (1‐6 months)
Notes	Source of funding: not specified Notes on validation of instruments (screening and outcomes): the STAI Spanish edition had been previously validated in Latin American countries; the scale used for distress evaluation was specifically developed for the study. Additional information: none Handling the data: not applicable Prospective trial registration number: not reported