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

Rochat, Tamsen J.; Dube, Samukelisiwe; Herbst, Kobus; Hoegfeldt, Cecilia A.; Redinger, Stephanie; Khoza, Thandeka; Bland, Ruth Margret; Richter, Linda; Linsell, Louise; Desmond, Chris; Yousafzai, Aisha K.; Craske, Michelle; Juszczak, Ed; Abas, Melanie; Edwards, Taygen; Ekers, David; Stein, Alan

Abstract

Background: The 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. Methods: This 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 registration: ISRCTN registry #11284870 (14/11/2017) and SANCTR DOH-27-102020-9097 (17/11/2017).

Citation

Rochat, T. J., Dube, S., Herbst, K., Hoegfeldt, C. A., Redinger, S., Khoza, T., Bland, R. M., Richter, L., Linsell, L., Desmond, C., Yousafzai, A. K., Craske, M., Juszczak, E., Abas, M., Edwards, T., Ekers, D., & Stein, A. (2021). 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. Trials, 22(1), Article 914. https://doi.org/10.1186/s13063-021-05672-0

• Journal Article Type: Article
• Acceptance Date: Sep 30, 2021
• Online Publication Date: Dec 13, 2021
• Publication Date: Dec 1, 2021
• Deposit Date: Dec 15, 2021
• Publicly Available Date: Dec 15, 2021
• Journal: Trials
• Electronic ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 22
• Issue: 1
• Article Number: 914
• DOI: https://doi.org/10.1186/s13063-021-05672-0
• Keywords: Pharmacology (medical); Medicine (miscellaneous)
• Public URL: https://nottingham-repository.worktribe.com/output/7017862
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05672-0
• Additional Information: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.