Cluster randomised trial to evaluate an intervention for depressed HIV-positive women in the perinatal period, to enhance child development and reduce maternal depression
| ISRCTN | ISRCTN11284870 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11284870 |
| Secondary identifying numbers | MR/P006965 Award |
- Submission date
- 07/11/2017
- Registration date
- 14/11/2017
- Last edited
- 09/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Perinatal depression is very common amongst HIV-positive women, with up to 40% of HIV-positive mothers in parts of southern Africa being affected. It is associated with poor adherence to anti-retroviral therapy (ART), low clinic attendance, suicidal ideation and low rates of breastfeeding. Critically, perinatal depression is also associated with negative effects on parenting, which in turn adversely impacts children's cognitive and behavioural development and growth. Effective treatments for HIV-positive perinatal populations are urgently needed, and given that the prevalence of both HIV and perinatal depression is high in low-resource settings, treatments which take an integrated approach, targeting both depression and parenting, have substantial potential. Behavioural Activation (BA) has been shown to be as effective as Cognitive Behaviour Therapy (CBT), the gold standard psychological therapy for treating depression in high-income settings, and it has begun to be used successfully in low and middle-income countries (LMIC). BA is much simpler than CBT to deliver, especially by non-specialist healthcare workers with limited training in under-resourced settings. It does not require extensive training or complex skills from therapists, and can be delivered by lay counsellors. Further, BA fits with cultural concepts of depression in southern Africa that place environmental stressors as the cause. Thus, given that BA targets behavioural changes rather than beliefs and attitudes, it is relatively easy to adapt BA cross-culturally with potential to be widely used to treat depression in LMIC as well as High Income Countries (HIC). BA is based on the evidence that increased activity (i.e., activation), and the resulting positive consequences, leads to reduction of depressive symptoms. BA helps the individual to participate in activities that have been avoided but are meaningful for her, and schedules them to fit into her daily life. BA introduces small changes, building up the level of activity gradually towards long-term goals, making it feasible for perinatal women with little time to spare. The parenting intervention aims to help the mother increase the stimulation she provides to her baby. In particular, the mother is helped to focus on her baby’s cues and signals and she is given support in providing a range of activities to enhance her child’s development, especially cognitive development. The mother is helped to develop a responsive and close relationship with her baby. The programme begins antenatally by providing the mother with information about parenting and how to plan and prepare for her baby. The programme was adapted from the ‘Care for Child Development’ package developed by UNICEF and WHO. The BA and the parenting programme were combined into a home-based integrated intervention package that can be delivered feasibly by lay counsellors. Thus the aim of this study is to investigate whether a home-based intervention, combining a psychological treatment for depression and a parenting programme, leads to better cognitive development in children at 2 years and reduces perinatal depression in HIV-positive women at 1 year after the birth, compared to enhanced standard of care.
Who can participate?
Pregnant women aged 16 and above who are HIV-positive, meet the criteria for depression, are conversant in either English or IsiZulu, and who plan to live with their child for the intensive period of the study, up to 9 months postnatal
What does the study involve?
Participants are randomly allocated to one of two groups based on area in which they live. One group receives the proposed intervention comprising the combined behavioural activation and parenting programme, with four sessions during pregnancy, six sessions in the 9 months following the birth of the child, and one booster session when the child is 16 months old.The other group receive enhanced standard of care, which includes four telephone support and advice calls, two during pregnancy and two after birth, where the participant is given advice and guided, if necessary, to existing services that they may need. All participants are also given a parenting information leaflet (published by UNICEF South Africa), in addition to the usual care provided at clinics. Maternal depression is assessed 12 months after the birth and child cognitive development is assessed at child age 24 months.
What are the possible benefits and risks of participating?
Some of the possible benefits to participants include reduced maternal depression and anxiety, improved adherence to antiretroviral treatment and increased rates of exclusive breastfeeding. For the child, improved cognitive and language development, a reduction in child behavioural difficulties, and improved health through compliance to immunization and reduced diarrhoea are some of the possible benefits. Given the nature of this study and the target population, a range of adverse situations are expected such as relationship problems/conflicts, feelings of hopelessness and suicidal thoughts as these are commonly associated with depression. To address this, there is a protocol in place to manage such situations appropriately.
Where is the study run from?
The centre from which the intervention will be run is the Africa Health Research Institute (AHRI) situated in Somkhele, KwaZulu-Natal, South Africa with research support from the University of Oxford in the United Kingdom and the University of Witwatersrand, situated in Johannesburg, South Africa.
When is the study starting and how long is it expected to run for?
April 2017 to March 2024
Who is funding the study?
This study is funded by the Joint Global Health Trials Panel; DfID, MRC UK, & the Wellcome Trust, and administered by the MRC UK
Who is the main contact?
1. Professor Alan Stein, alan.stein@psych.ox.ac.uk
2. Dr Tamsen Rochat, tamsen.rochat@wits.ac.za
Contact information
Scientific
University Department of Psychiatry
Warneford Hospital
University of Oxford
Oxford
OX3 7JX
United Kingdom
| Phone | +44 (0)1865 618170 |
|---|---|
| alan.stein@psych.ox.ac.uk |
Scientific
Developmental Pathways for Health Research Unit
University of the Witwatersrand
1 Jan Smuts Avenue
Braamfontein 2000
Johannesburg
-
South Africa
| Phone | +27 (0)119331122 |
|---|---|
| tamsen.rochat@wits.ac.za |
Study information
| Study design | Single-centre cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request participant information sheet |
| Scientific title | Cluster randomised trial to evaluate an integrated behavioural activation and parenting intervention for depressed HIV-positive women in the perinatal period, to enhance child cognitive development at 24 months of age and reduce maternal depression at 12 months postnatal |
| Study acronym | Insika Yomama (Pillar for Mothers) |
| Study objectives | The hypothesis for this trial is that a psychological intervention, integrating behavioural activation for perinatal depression and a parenting programme, will lead to better cognitive development in children at 24 months and reduced maternal depression in HIV-positive women at 12 months postnatal, compared to enhanced standard of care (ESoC). |
| Ethics approval(s) | 1. Human Sciences Research Council (HSRC), South Africa, 20/02/2018, ref: #REC 5/23/08/17 2. Oxford Tropical Research Ethics Committee (OxTREC), 06/12/2017, ref: #31-17 |
| Health condition(s) or problem(s) studied | Perinatal depression in women with HIV infection |
| Intervention | Participants are randomised by cluster, based on homestead location at enrolment, with outcome assessors blind to treatment allocation: 1. 10-session home-based counselling intervention delivered by lay counsellors that combines Behavioural Activation (BA) for depression with a parenting programme, adapted from the Care for Child Development (CCD) package. The intervention includes 4 sessions in the third trimester of pregnancy, and 6 sessions in the first nine months post-delivery, with a booster session at 16 months. The first session will be up to 2 hours, and subsequent sessions will be up to 1 1/2 hours each. 2. Enhanced standard of care (ESoC) which comprises of two antenatal and two postnatal support and advice telephone calls. |
| Intervention type | Behavioural |
| Primary outcome measure | Co-primary outcome measures: 1. Child cognitive development, measured using the Bayley Scales of Infant and Toddler Development III (cognitive subscale) at child age 24 months 2. Maternal depression, measured using the Edinburgh Postnatal Depression Scale (EPDS) at 12 months postnatal |
| Secondary outcome measures | Current secondary outcome measures as of 14/12/2022: 1. Maternal depression, measured using the Edinburgh Postnatal Depression Scale (EPDS) at the end of pregnancy and child age 24 months 2. Generalized Anxiety Disorder 7-item (GAD-7) scale at the end of pregnancy and child age 24 months 3. Adherence to ART, measured as viral load (VL) and viral suppression post-initiation of treatment over the entire trial period 4. Exclusive breastfeeding to 6 months by self-report in an interview at 6 months postnatal 5. Compliance with immunisation schedule over the 24-month postnatal period, by maternal report at interview and clinic record at 12 weeks, 12 and 24 months postnatal 6. Any instances of infant diarrhoea in the preceding two weeks, assessed by the maternal report in an interview at 12 weeks, 6 months, 12 months and the 24 months 7. Cognitive and emotional stimulation at home, assessed by Multiple Indicator Cluster Survey 6 (MICS6) at 12 and 24 months 8. Infant behaviour, assessed using the Parent-Child Dysfunctional Interaction subscale and Difficult Child subscale of the Parenting Stress Index Short Form (PSI-SF) at child age of 12 months, and the Externalising Subscale of the Child Behaviour Checklist (CBCL) at 24 months 9. Infant language development, measured using the BSID-III language sub-scale at child age 24 months 10. Child growth - height and weight for child age measured at 24 months Previous secondary outcome measures: 1. Maternal depression, measured using the Edinburgh Postnatal Depression Scale (EPDS) at the end of pregnancy and child age 24 months 2. Generalized Anxiety Disorder 7-item (GAD-7) scale at the end of pregnancy and child age 24 months 3. Adherence to ART, measured as viral load (VL) and viral suppression post-initiation of treatment over the entire trial period 4. Exclusive breastfeeding to 6 months by self-report in interview at 6 months postnatal 5. Compliance to immunisation schedule over the 24-month postnatal period, by maternal report at interview and clinic record at 12 weeks, 12 and 24 months postnatal 6. Any instances of infant diarrhoea in the preceding two weeks, assessed by maternal report in interview at 12 weeks, 6 months, 12 months and the 24 months 7. Maternal contingent responsiveness to infant cues and cognitive and emotional stimulation at home, assessed by video observation of mother-child interaction at child age 12 and 24 months 8. Infant behaviour, assessed using the Difficult Child subscale of the Parenting Stress Index (PSI) at child age 12 months, and the Child Behaviour Checklist (CBCL) at 24 months 9. Infant language development, measured using the BSID-III language sub-scale at child age 24 months 10. Child growth - height and weight for child age measured at 24 months |
| Overall study start date | 01/04/2017 |
| Completion date | 31/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 48 - 60 clusters with 9-11 women per cluster, 528 total |
| Total final enrolment | 320 |
| Key inclusion criteria | Current inclusion criteria as of 14/12/2022: 1. Pregnant women, 23-33 weeks gestation at the time of enrolment 2. Participant is willing and able to give informed consent for participation in the trial 3. Aged 16 years and above 4. Diagnosed HIV-positive 5. Mother meets criteria for antenatal depression as defined by 9 and greater on the EPDS 6. Living, or planning to live, within the study area at the time of delivery and for at least 9 months after delivery (the intensive therapy period) 7. Mother conversant in isiZulu or English Current inclusion criteria as of 25/01/2019 to 14/12/2022: 1. Pregnant women, <33 weeks gestation at time of enrolment 2. Participant is willing and able to give informed consent for participation in the trial 3. Aged 16 years and above 4. Diagnosed HIV-positive 5. Mother meets criteria for antenatal depression as defined by 9 and greater on the EPDS 6. Living, or planning to live, within the study area at the time of delivery and for at least 9 months after delivery (the intensive therapy period) 7. Mother conversant in isiZulu or English Previous inclusion criteria: 1. Pregnant women, <33 weeks gestation at time of enrolment 2. Participant is willing and able to give informed consent for participation in the trial 3. Aged 16 years and above 4. Diagnosed HIV-positive 5. Mother meets criteria for antenatal depression as defined by 13 and greater on the EPDS 6. Living, or planning to live, within the study area at the time of delivery and for at least 9 months after delivery (the intensive therapy period) 7. Mother conversant in isiZulu or English |
| Key exclusion criteria | 1. Any significant disease, disorder or disability which, in the opinion of the Principal Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. This includes hospitalisation for at least three days for severe psychiatric illness (specifically bipolar disorder, schizophrenia and any other psychoses), or a life-threatening or other serious physical illness (excluding HIV and tuberculosis) 2. Current suicidal ideation/thoughts with specific plans and means identified 3. Substance or alcohol use disorder 4. Currently receiving a psychological treatment for mental health problems 5. Participant planning to move away from the study area before 9 months postnatal 6. Mother not planning to cohabit with the infant |
| Date of first enrolment | 04/04/2018 |
| Date of final enrolment | 13/07/2021 |
Locations
Countries of recruitment
- South Africa
Study participating centre
Via R618 to Hlabisa
Somkhele
Mtubatuba
3935
South Africa
Sponsor information
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study protocol and statistical analysis plan will be available. The aim is to publish the trial results in a high-impact journal within 12 months of the data collection being completed. |
| IPD sharing plan | Current IPD sharing statement as of 14/12/2022: The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Alan Stein (alan.stein@psych.ox.ac.uk) after de-identification. Individual participant data for this trial will be available in accordance with the information outlined below: Individual participant quantitative data that underlie the results reported in each publication arising from the trial will be made available after de-identification. Any video, audio or qualitative data will not be available. Data will be available beginning 9 months and ending 36 months following the main article publication to researchers who provide a methodologically sound proposal that proposes 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. Previous IPD sharing statement: The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Alan Stein (alan.stein@psych.ox.ac.uk) after de-identification. Data will be available between 12 months until 48 months after publication to researchers who provide a methodologically sound proposal to either achieve the aims in the approved proposal or for individual participant data meta-analysis. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol (preprint) | 28/04/2021 | 19/10/2021 | No | No | |
| Statistical Analysis Plan | version 1.0 | 06/11/2023 | 29/11/2023 | No | No |
| Protocol article | 03/08/2024 | 09/08/2024 | Yes | No |
Additional files
Editorial Notes
09/08/2024: Publication reference added.
23/07/2024: The intention to publish date was changed from 31/07/2024 to 30/06/2025.
20/12/2023: The following changes were made:
1. The overall study end date was changed from 31/12/2023 to 31/03/2024.
2. The intention to publish date was changed from 31/10/2024 to 31/07/2024.
29/11/2023: Uploaded statistical analysis plan.
20/12/2022: Internal review.
14/12/2022: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/10/2023 to 31/12/2023 and the plain English summary was updated accordingly.
2. The inclusion criteria have been changed.
3. The individual participant data (IPD) sharing statement has been changed.
4. The secondary outcome measures have been changed.
19/10/2021: The following changes were made to the trial record:
1. Publication reference and total final enrolment added.
2. The recruitment end date was changed from 30/09/2021 to 13/07/2021.
06/05/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2021 to 30/09/2021.
2. The overall trial end date was changed from 31/05/2023 to 31/10/2023.
3. The intention to publish date was changed from 31/05/2024 to 31/10/2024.
4. Recruitment to this study is no longer paused.
24/04/2020: Due to current public health guidance, recruitment for this study has been paused.
19/11/2019: The following changes have been made:
1. The scientific contact has been changed and a second contact added.
2. The overall trial end date has been changed from 31/03/2022 to 31/05/2023.
3. The intention to publish date has been changed from 31/03/2023 to 31/05/2024.
4. The plain English summary has been updated accordingly.
18/11/2019: The recruitment end date has been changed from 31/08/2020 to 30/04/2021.
25/01/2019: The following changes have been made:
1. The ethics approval dates have been added.
2. The participant inclusion criteria have been changed.
3. The target number of participants has been changed from"48 clusters with 11 women per cluster, 528 total" to "48 - 60 clusters with 9-11 women per cluster, 528 total".
4. The recruitment start date has been changed from 15/01/2018 to 04/04/2018.
5. The recruitment end date has been changed from 31/03/2020 to 31/08/2020.
