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.

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.
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DOI:
10.1186/s13063-021-05672-0
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发表时间:
2021-12-13
期刊:
影响因子:
2.5
通讯作者:
Stein A
Stein A
中科院分区:
医学4区
文献类型:
--
作者:
Rochat TJ;Dube S;Herbst K;Hoegfeldt CA;Redinger S;Khoza T;Bland RM;Richter L;Linsell L;Desmond C;Yousafzai AK;Craske M;Juszczak E;Abas M;Edwards T;Ekers D;Stein A

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围产期贫穷、艾滋病毒和抑郁症的结合是许多南部非洲国家的一个重大公共卫生挑战。在一些地区,多达三分之一的艾滋病毒抗体阳性妇女经历围产期抑郁症。围产期抑郁症与父母养育和儿童发展的关键领域,包括认知,行为和成长的负面影响有关,特别是在社会经济弱势社区。有几项研究记录了心理干预对低收入和中等收入国家围产期抑郁症的益处,但没有一项研究评估了使用任务分担对艾滋病毒阳性妇女进行综合心理和养育干预。这项随机对照试验旨在评估家庭干预的效果,结合抑郁症的心理治疗和围产期抑郁的艾滋病毒阳性妇女的育儿计划。这项研究是一项随机分组对照试验,包括48 - 60个地理空间集群。从南非夸祖鲁-纳塔尔农村产前诊所招募了总共528名年龄≥ 16岁、符合爱丁堡产后抑郁量表(EPDS,评分≥ 9)抑郁标准的艾滋病毒阳性孕妇。地理空间集群以1:1的分配比例随机分配到干预或增强标准治疗(ESoC)。干预组接受10次由非专业顾问提供的家庭咨询(4次产前咨询和6次产后咨询),并在16个月时接受一次加强咨询。这项干预措施将抑郁症的行为激活与根据儿童基金会/卫生组织儿童发展护理方案改编的父母养育方案相结合。ESoC小组接到两个产前和两个产后咨询支助和咨询电话。此外,还采取措施提高日常护理标准。共同主要结局为24个月时采用Bayley婴儿发育量表(第三版)的认知子量表评估的儿童认知发育和12个月时采用EPDS测量的母亲抑郁。主要分析将是改良的意向治疗分析。将使用混合效应线性回归分析主要结局。如果这种治疗成功,政策制定者可以在艾滋病毒治疗方案中使用这种由非专业顾问提供的精神保健模式,为受艾滋病毒影响的家庭提供更全面的服务。ISRCTN登记编号11284870(2017年11月14日)和SANCTR DOH-27 - 102020 - 9097(2017年11月17日)。
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. 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. The primary analysis will be a modified intention-to-treat analysis. The primary outcomes will be analysed using mixed-effects linear regression. 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. ISRCTN registry #11284870 (14/11/2017) and SANCTR DOH-27-102020-9097 (17/11/2017).
DOI: 10.1016/s0140-6736(16)31389-7
发表时间: 2017-01-07
期刊: Lancet (London, England)
影响因子: --
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通讯作者: Lancet Early Childhood Development Series Steering Committee
DOI: 10.1186/1471-2431-12-11
发表时间: 2012-02-01
期刊: BMC pediatrics
影响因子: 2.4
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通讯作者: Cooper PA
DOI: 10.1016/j.bpobgyn.2013.08.013
发表时间: 2014-01
影响因子: 5.5
作者:
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通讯作者: Patel, Vikram
DOI: 10.1097/qad.0b013e3283601b53
发表时间: 2013-06-01
期刊: AIDS (London, England)
影响因子: --
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DOI: 10.1097/qai.0000000000000258
发表时间: 2014-09-01
影响因子: 3.6
作者:
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通讯作者: Abas, Melanie