Evidence map›Paper›PMID 34903257›Full record

ArticleTrials2021

An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: study protocol for the Insika Yomama cluster randomised controlled trial.

Tamsen J Rochat, Samukelisiwe Dube, Kobus Herbst, Cecilia A Hoegfeldt, Stephanie Redinger, Thandeka Khoza, Ruth Margret Bland, Linda Richter, Louise Linsell, Chris Desmond and 7 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 10 institutions in 3 countries.

Tamsen J RochatSAMRC/Wits Developmental Pathways for Health Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Samukelisiwe DubeAfrica Health Research Institute, Durban, KwaZulu-Natal, South Africa.
Kobus HerbstAfrica Health Research Institute, Durban, KwaZulu-Natal, South Africa.
Cecilia A HoegfeldtDepartment of Psychiatry, University of Oxford, Oxford, UK.
Stephanie RedingerSAMRC/Wits Developmental Pathways for Health Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Thandeka KhozaDSI-NRF Centre of Excellence in Human Development, University of the Witwatersrand, Johannesburg, South Africa.
Ruth Margret BlandInstitute of Health and Wellbeing and Royal Hospital for Children, University of Glasgow, Glasgow, UK.
Linda RichterDSI-NRF Centre of Excellence in Human Development, University of the Witwatersrand, Johannesburg, South Africa.
Louise LinsellNational Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Chris DesmondPriceless, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Aisha K YousafzaiHarvard T.H. Chan School of Public Health, Boston, USA.
Michelle CraskeUCLA, Los Angeles, USA.
Ed JuszczakNational Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Melanie AbasInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Taygen EdwardsDSI-NRF Centre of Excellence in Human Development, University of the Witwatersrand, Johannesburg, South Africa.
David EkersTees Esk and Wear Valleys NHS FT, Darlington, UK.
Alan SteinDSI-NRF Centre of Excellence in Human Development, University of the Witwatersrand, Johannesburg, South Africa. alan.stein@psych.ox.ac.uk.ORCID http://orcid.org/0000-0001-8207-2822
University of the Witwatersrand · ZAUniversity of Oxford · GBAfrica Health Research Institute · ZASouth African Medical Research Council · ZADurban University of Technology · ZAHarvard University · USKing's College London · GBRoyal Hospital for Children · GBTees, Esk and Wear Valleys NHS Foundation Trust · GBUCLA Health · US

Funding

Medical Research Council MC_PC_14096Medical Research Council MR/P006965/1Wellcome Trust 211374/Z/18/ZWellcome Trust MR/P006965/1
6 · The paper itself

Abstract

backgroundThe combination of poverty, HIV and depression in the perinatal period represents a major public health challenge in many Southern African countries. In some areas, up to a third of HIV-positive women experience perinatal depression. Perinatal depression is associated with negative effects on parenting and key domains of child development including cognitive, behavioural and growth, especially in socio-economically disadvantaged communities. Several studies have documented the benefits of psychological interventions for perinatal depression in low- and middle-income countries, but none have evaluated an integrated psychological and parenting intervention for HIV-positive women using task-sharing. This randomised controlled trial aims to evaluate the effect of a home-based intervention, combining a psychological treatment for depression and a parenting programme for perinatally depressed HIV-positive women.

methodsThis study is a cluster randomised controlled trial, consisting of 48-60 geospatial clusters. A total of 528 pregnant HIV-positive women aged ≥ 16 years who meet the criteria for depression on the Edinburgh Postnatal Depression Scale (EPDS, score ≥ 9)) are recruited from antenatal clinics in rural KwaZulu-Natal, South Africa. The geospatial clusters are randomised on an allocation ratio of 1:1 to either the intervention or Enhanced Standard of Care (ESoC). The intervention group receives 10 home-based counselling sessions by a lay counsellor (4 antenatal and 6 postnatal sessions) and a booster session at 16 months. The intervention combines behavioural activation for depression with a parenting programme, adapted from the UNICEF/WHO Care for Child Development programme. The ESoC group receives two antenatal and two postnatal counselling support and advice telephone calls. In addition, measures have been taken to enhance the routine standard of care. The co-primary outcomes are child cognitive development at 24 months assessed on the cognitive subscale of the Bayley Scales of Infant Development-Third Edition and maternal depression at 12 months measured by the EPDS. ANALYSIS: The primary analysis will be a modified intention-to-treat analysis. The primary outcomes will be analysed using mixed-effects linear regression. DISCUSSION: If this treatment is successful, policymakers could use this model of mental healthcare delivered by lay counsellors within HIV treatment programmes to provide more comprehensive services for families affected by HIV.

trial registrationISRCTN registry # 11284870 (14/11/2017) and SANCTR DOH-27-102020-9097 (17/11/2017).

Indexed as

Child DevelopmentHIV InfectionsChildDepressionFemaleHumansInfantParentingPregnancyRandomized Controlled Trials as TopicSouth AfricaBehavioural activationChild developmentHIVLay counsellorsParentingPerinatal depression

Identifiers

PMID34903257
PMCPMC8666837
OpenAlexW4225547391

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.