Condition category
Mental and Behavioural Disorders
Date applied
07/11/2017
Date assigned
14/11/2017
Last edited
13/11/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

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) Africa Centre Building situated in Somkhele, KwaZulu-Natal, South Africa with research support from the University of Oxford in the United Kingdom and the Human Sciences Research Council (HSRC) situated in Durban, South Africa.

When is study starting and how long is it expected to run for?
April 2017 to March 2022

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. Prof. Alan Stein
alan.stein@psych.ox.ac.uk
2. Dr Tamsen Rochat
TRochat@hsrc.ac.za

Trial website

Contact information

Type

Scientific

Primary contact

Dr Francois van Loggerenberg

ORCID ID

Contact details

University Department of Psychiatry
Warneford Hospital
University of Oxford
Oxford
OX3 7JX
United Kingdom
+44 (0)1865 618170
francois.vanloggerenberg@psych.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MR/P006965 Award

Study information

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

Acronym

Insika Yomama (Pillar for Mothers)

Study hypothesis

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

1. Human Sciences Research Council (HSRC), South Africa, provisionally approved pending revisions 18/10/2017, ref: #REC 5/23/08/17
2. Oxford Tropical Research Ethics Committee (OxTREC), submitted 17/08/2017 - currently under review pending revisions and some requested changes, ref: #31-17

Study design

Single-centre cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request participant information sheet

Condition

Perinatal depression, HIV

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

Phase

Drug names

Primary outcome measures

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

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 trial start date

01/04/2017

Overall trial end date

31/03/2022

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

48 clusters with 11 women per cluster, 528 total

Participant 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

Recruitment start date

15/01/2018

Recruitment end date

31/03/2020

Locations

Countries of recruitment

South Africa

Trial participating centre

Africa Health Research Institute (AHRI)
Africa Centre Building Via R618 to Hlabisa Somkhele
Mtubatuba
3935
South Africa

Sponsor information

Organisation

The University of Oxford

Sponsor details

University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Joint Global Health Trials Panel, DFID, Wellcome Trust & MRC UK

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 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.

Intention to publish date

31/03/2023

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes