TY - JOUR
T1 - 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
T2 - study protocol for the Insika Yomama cluster randomised controlled trial
AU - Rochat, Tamsen J.
AU - Dube, Samukelisiwe
AU - Herbst, Kobus
AU - Hoegfeldt, Cecilia A.
AU - Redinger, Stephanie
AU - Khoza, Thandeka
AU - Bland, Ruth Margret
AU - Richter, Linda
AU - Linsell, Louise
AU - Desmond, Chris
AU - Yousafzai, Aisha K.
AU - Craske, Michelle
AU - Juszczak, Ed
AU - Abas, Melanie
AU - Edwards, Taygen
AU - Ekers, David
AU - Stein, Alan
N1 - Funding Information:
The study is funded by the Joint Global Health Trials (MRC(UK)/DFID/Wellcome) [Grant number MR/P006965/1]. An additional supplement has been provided by the UKRI (UKRI COVID Allocation). The Oxford Health Biomedical Research Centre (BRC) has also provided some supplemental funding to the trial for the development of the electronic version of the therapy manual.
Funding Information:
We are grateful to the Africa Health Research Institute, especially the Clinical Research Department and the Data Management team, including Siphephelo Dlamini, Fikile Mdamba, Njabulo Dayi and Dickman Gareta as well as Valerie West, Francois van Loggerenberg and Heather O?Mahen. AS and TJR conceptualised the study. The paper was drafted by CH and AS with input from SR, TJR and LL. All authors reviewed and commented on the manuscript and approved the final version. The study is funded by the Joint Global Health Trials (MRC(UK)/DFID/Wellcome)?[Grant number MR/P006965/1]. An additional supplement has been provided by the UKRI (UKRI COVID Allocation). The Oxford Health Biomedical Research Centre (BRC) has also provided some supplemental funding to the trial for the development of the electronic version of the therapy manual. Data will be available beginning 9?months and ending 36?months following main article publication to researchers who provide a methodologically sound proposal that purposes to achieve aims in the approved proposal and /or for individual participant data meta-analysis. Data is documented and stored on the Africa Health Research Institute (AHRI) Data Repository (https://data.ahri.org) with a digital object identifier (doi) and can be accessed with permission and in line with AHRI policies and procedures. Data requestors will need to sign a data access agreement before any data can be shared. In addition, Study Protocol and Statistical Analysis Plan documents will be available. Data sets associated with publications will be made available in line with Wellcome Trust data policies and journal requirements.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - 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).
AB - 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).
KW - Behavioural activation
KW - Child development
KW - HIV
KW - Lay counsellors
KW - Parenting
KW - Perinatal depression
UR - http://www.scopus.com/inward/record.url?scp=85121100091&partnerID=8YFLogxK
U2 - 10.1186/s13063-021-05672-0
DO - 10.1186/s13063-021-05672-0
M3 - Article
AN - SCOPUS:85121100091
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
IS - 1
M1 - 914
ER -
