Rahman 2008.

Study characteristics
Methods	Study design: cluster‐RCT single‐blind study with 2 parallel groups (unit of allocation ‐ union council clusters, 20 clusters per arm, 40 in total; unit of analysis ‐ individual) Duration of study: enrolments between April 2005 and March 2006
Participants	Country: Pakistan Income classification: low‐income country Geographical scope: rural area of Pakistan where there was subsistence farming Healthcare setting: home Mental health condition: antenatal depression in third trimester Population 1. Age: 16 to 45 years 2. Gender: female 3. Socioeconomic background: 68% of cases and controls were poor; nearly 40% relying on well without pump; 55% relying on the field for toilets and "subsistence farming, supplemented by one or more of the men serving in the armed forces or working as government employees, or as semi‐skilled or unskilled labourers in the cities". "Male and female literacy rates are 79.6% and 48.6%, respectively". "Infant mortality rates are 84 per 1000 live births" 4. Inclusion criteria a. Women in the 40 Union Councils who were aged 16 to 45 years, married, and in the third trimester of pregnancy (1) They were enrolled from lists of participants compiled from official registers kept with the Lady Health Workers 5. Exclusion criteria a. Women with a diagnosed serious medical condition requiring inpatient or outpatient treatment b. Pregnancy‐related illness (except for common conditions, such as anaemia) c. Substantial physical or learning disability d. Postpartum or other form of psychosis
Interventions	Stated purpose: to develop and deliver a psychological intervention to depressed mothers and their infants through non‐specialist village‐based health workers INTERVENTION (n = 418) Name: thinking healthy programme Delivered by: LHW Title/name of PW and number: lady health workers ‐ 40 1. Selection: existing staff in union councils were trained to deliver the intervention 2. Educational background: completed secondary schools 3. Training: 2‐day workshop and 1‐day refresher 3 months after first training were all given by study team psychiatrist. Here and now problem‐solving CBT was used with a manual that used culturally appropriate illustrations. Included in the training were the 3 steps that helped in avoiding direct confrontation with mothers and managing illiterate mothers 4. Supervision: research team meetings in which "health workers brainstorm for solutions and discuss their successes and failures in a supportive environment" 5. Incentives/remuneration: not mentioned Intervention details 1. Duration/frequency: session every week for 4 weeks in the last month of pregnancy, 3 sessions in the first postnatal month, and nine 1‐monthly sessions thereafter 2. Content of intervention: 3‐step approach: (1) identify unhealthy unhelpful thinking styles and behaviours; (2) replace these with helpful or healthy thinking; (3) provide activities and 'homework' to help mothers practice healthy thinking CONTROL: enhanced usual care (n = 400) "Control clusters received an equal number of visits in exactly the same way as those in the intervention group, but by routinely trained Lady Health Workers (two for each Union Council)" CO‐INTERVENTIONS: none
Outcomes	Patients 1. Infant weight and height at 6 and 12 months*§ 2. Maternal depression 3. Exclusive breastfeeding§ 4. Number of diarrhoeal episodes in infants in the 2 weeks before interview§ 5. Records of immunisation§ (with or without up‐to‐date immunisation status) 6. Use of contraception§ 7. Whether both parents set aside time every day to play with their infant§ Carers (mothers) 1. Structured clinical interview for DSM‐IV diagnosis (screening) 2. HDRS (for outcomes) 3. Brief disability questionnaire§ 4. Global assessment of functioning questionnaire 5. Multi‐dimensional scale for perceived social support§ Process/health workers None Economic outcomes None (*: primary outcomes of the study; §: outcomes that we have not reported in this review) Time points post intervention: baseline, 3 months (6 months postnatally), 9 months (12 months postnatally)
Notes	Source of funding: this research was funded by a career development fellowship awarded to Atif Rahman by Wellcome Trust, UK Notes on validation of instruments (screening and outcomes): Structured Clinical Interview for DSM‐IV diagnosis and HDRS are internationally validated, but not specified if validated for Pakistani settings. Other mother outcome scales not validated. Child outcome tools validated Additional information: study protocol is not present. Declarations of interest ‐ study authors declared no conflicts of interest Handling the data: as per footnotes in data and analysis Prospective trial registration number: ISRCTN65316374
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "40 Union Councils in the two subdistricts of the study area. These subdistricts were geographically contiguous and ethnically, culturally, and socioeconomically homogeneous. All the units were eligible for randomisation, which was done by an independent trial centre in Islamabad, before recruitment of participants. These administrative units were assigned by random allocation with a table of random numbers by a researcher who was not involved in the study and who was unaware of the identity of the Union Councils. Lady Health Workers from each Union Council were enrolled to participate in the study before randomisation" Comment: adequate
Allocation concealment (selection bias)	Low risk	Quote: "the interviewers were unaware of the allocation status of the Union Councils (because they had no contact with the team that did the randomisation), and we took care to ensure they remained so; none of the interviewers resided in the study area, and throughout the duration of the study they had no contact with the Lady Health Workers or any other health personnel in the study area. Mothers were asked not to tell the interviewers anything about their sessions with Lady Health Workers" Comment: adequate
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "mothers in the control clusters received an equal number of visits in exactly the same way as those in the intervention group, but by routinely trained Lady Health Workers (two for each Union Council). These health workers in both groups received monthly supervision, and were monitored by the research team to ensure that they were attending the scheduled visits. In practice, the Lady Health Workers seldom provide such structured and monitored care in the community. The control group thus received what would be regarded as ideal care, which we called enhanced routine care"
Blinding of outcome assessment (detection bias) all outcomes	Unclear risk	Subjective outcomes: Quote: "the interviewers were unaware of the allocation status of the Union Councils (because they had no contact with the team that did the randomisation), and we took care to ensure they remained so; none of the interviewers resided in the study area, and throughout the duration of the study they had no contact with the Lady Health Workers or any other health personnel in the study area. Mothers were asked not to tell the interviewers anything about their sessions with Lady Health Workers" Comment: likely low risk, although small risk that mothers may have told aspects of their interactions with LHWs to interviewers Objective outcomes: Quote: "all infant outcomes were assessed by researchers unaware of the psychiatric status of the mother" Comment: > 80% of participants deemed low risk
Baseline outcome measurements similar	Low risk	Comment: all similar
Baseline characteristics similar?	Low risk	Comment: all similar
Incomplete outcome data (attrition bias) Efficacy data	Low risk	Comment: all outcomes stated to be collected are reported
Protection against contamination	Low risk	Quote: "normally one Basic Health Unit provides primary health care for one Union Council and all affiliated Lady Health Workers work in villages within that Union Council only. Supervision of health workers takes place in the Union Council. Thus the risk of contamination of the control group with the intervention is negligible"
Selective reporting (reporting bias)	Low risk	Comment: no selective reporting
Other bias	Low risk	Comment: no other obvious sources of bias