RCT to evaluate an intervention for depressed HIV-positive women in the perinatal period, to enhance child development and reduce maternal depression

随机对照试验评估围产期艾滋病毒阳性女性抑郁症的干预措施，以促进儿童发育并减少孕产妇抑郁症

• 批准号: MR/P006965/1
• 负责人: Alan Stein
• 金额: $ 376.73万
• 依托单位: University of Oxford
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2017
• 资助国家: 英国
• 起止时间: 2017 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FP006965%2F1
• 关键词: RCT; evaluate; intervention; depressed; HIV

The majority of people living with HIV in the world live in sub-Saharan Africa (SSA), with women of child-bearing age carrying the greatest burden. Up to 35% of women attending antenatal clinics in some parts of South Africa are HIV-positive. Many receive their diagnosis during pregnancy when they are screened for HIV. Depression afflicts many HIV-positive women during pregnancy; over 40% score above the threshold for depression on screening questionnaires, and approximately 23% fulfil diagnostic criteria. Depression is associated with reduced adherence to ART, as well as low clinic attendance, suicidal thoughts, and low rates of exclusive breastfeeding. Moreover, perinatal depression has negative effects on parenting and early child development. Children born to depressed mothers are at increased risk of compromised cognitive development, behaviour and growth, especially when faced with socio-economic disadvantage and lack of support. There is also emerging evidence from a separate body of literature that HIV is associated with negative effects on caregiving and children's outcomes (the vast majority of these children are HIV-negative). Improving the wellbeing of mothers and infants requires effective treatment of perinatal depression, ensuring adherence to ART, as well as enhancing key parenting skills. In particular, depressed mothers often need help to sensitively respond to and care for their infants in order to mitigate the negative effects of depression on parenting. Our aim is to conduct a cluster RCT to test an integrated home-based intervention programme that jointly treats depression and enhances parenting. The intervention, delivered during pregnancy and the postnatal period, comprises a combination of behavioural activation (BA) therapy to treat the symptoms of depression and a parenting programme to improve maternal responsiveness to infants (CCD). BA is a structured therapeutic approach that focuses on increasing behaviours that are rewarding, improving mood and quality of life, and reducing behaviours that maintain or worsen depression such as passivity or avoidance and rumination. It has been shown to be as effective as CBT. This focus on behaviour rather than beliefs makes BA culturally acceptable. Another advantage of BA is that it does not require extensive training for delivery or complex skills from the therapist; thus lay counsellors can deliver this treatment. CCD, developed by WHO/UNICEF, has been shown to improve parenting and promote early child development in LMIC when integrated in existing health services. We have augmented CCD to focus particularly on parenting skills in early infant learning and attention, especially contingent responsiveness and the provision of early stimulation opportunities. The control treatment will be enhanced treatment as usual, comprising standard care with an additional in-person therapy session during pregnancy, two follow-up phone calls, and a parenting booklet in the postnatal period. The RCT will comprise 48 clusters (24 per arm) with 11 mothers (and infants) per cluster. This includes an additional 25% to take account of attrition, for a total of 528 mothers and infants. Women who meet criteria (i.e. have depression during pregnancy and are HIV-positive) will be recruited between 20 and 32 weeks of pregnancy and followed until the child is aged 2 years. The main aims of the trial are to test whether the intervention: 1. Improves child cognitive development at 2 years of age 2. Reduces maternal depression during pregnancy and the postnatal period 3. Increases maternal adherence to ART 4. Increases rates of exclusive breastfeeding5. Improves maternal contingent responsiveness to infant cues and quality of cognitive and emotional stimulation6. Improves child growth, behaviour, and language development, and reduces gastro-intestinal infections

世界上大多数艾滋病毒感染者生活在撒哈拉以南非洲，育龄妇女承受着最大的负担。在南非某些地区，到产前诊所就诊的妇女中艾滋病毒抗体呈阳性者高达35%。许多人在怀孕期间接受艾滋病毒筛查时得到诊断。抑郁症困扰着许多艾滋病毒阳性的妇女在怀孕期间;超过40%的得分高于抑郁症的阈值，大约23%符合诊断标准。抑郁症与抗逆转录病毒治疗依从性降低、低门诊出勤率、自杀念头和纯母乳喂养率低有关。此外，围产期抑郁症对父母养育和儿童早期发育有负面影响。患有抑郁症的母亲所生的儿童在认知发展、行为和成长方面受到损害的风险更大，特别是在面临社会经济劣势和缺乏支持的情况下。另一系列文献也有新的证据表明，艾滋病毒与护理和儿童结局的负面影响有关（这些儿童中绝大多数是艾滋病毒阴性）。改善母亲和婴儿的福祉需要有效治疗围产期抑郁症，确保坚持抗逆转录病毒疗法，以及提高关键的育儿技能。特别是，抑郁的母亲往往需要帮助，以敏感地回应和照顾他们的婴儿，以减轻抑郁症对养育子女的负面影响。我们的目的是进行一项随机对照试验，以测试一个综合的家庭为基础的干预计划，共同治疗抑郁症和提高养育。在怀孕期间和产后期间提供的干预措施包括行为激活疗法（BA）治疗抑郁症症状和育儿方案，以改善母亲对婴儿的反应（CCD）。BA是一种结构化的治疗方法，重点是增加奖励行为，改善情绪和生活质量，减少维持或恶化抑郁症的行为，如被动或回避和沉思。事实证明，它与CBT一样有效。这种对行为而不是信仰的关注使得BA在文化上是可以接受的。BA的另一个优点是，它不需要治疗师进行广泛的培训或复杂的技能;因此，非专业顾问可以提供这种治疗。由世卫组织/儿童基金会开发的防治荒漠化公约，在纳入现有保健服务时，已证明可改善父母养育子女的情况，促进低收入中等收入国家儿童的早期发展。我们已加强幼儿发展中心，特别集中于幼儿学习和注意力方面的父母技巧，特别是应变能力和提供早期刺激机会。对照治疗将像往常一样加强治疗，包括标准护理，怀孕期间额外的面对面治疗，两次随访电话和产后育儿手册。RCT将包括48个群组（每组24个），每个群组有11名母亲（和婴儿）。这包括另外25%的自然减员，共计528名母亲和婴儿。符合标准的妇女（即在怀孕期间患有抑郁症且艾滋病毒呈阳性）将在怀孕20至32周之间招募，并随访至孩子2岁。试验的主要目的是测试干预是否：1。改善2岁时儿童的认知发育2。减少产妇抑郁症在怀孕期间和产后3.增加孕产妇对抗逆转录病毒疗法4的坚持。提高纯母乳喂养率5。改善产妇对婴儿线索的应急反应以及认知和情感刺激的质量6。促进儿童生长、行为和语言发育，减少胃肠道感染

项目成果

Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial.

• DOI: 10.1016/s0140-6736(18)31813-0
• 发表时间: 2018-12-15
• 期刊: Lancet (London, England)
• 作者: Hartley C;Moultrie F;Hoskin A;Green G;Monk V;Bell JL;King AR;Buckle M;van der Vaart M;Gursul D;Goksan S;Juszczak E;Norman JE;Rogers R;Patel C;Adams E;Slater R
• 通讯作者: Slater R

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.

• DOI: 10.1186/s13063-021-05672-0
• 发表时间: 2021-12-13
• 期刊: Trials
• 影响因子: 2.5
• 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
• 通讯作者: Stein A

Thoughts of self-harm in early and late pregnancy in urban South Africa: Investigating prevalence, predictors and screening options.

南非城市地区怀孕早期和晚期的自残想法：调查患病率、预测因素和筛查方案。

• DOI: 10.7196/samj.2021.v111i7.15058
• 发表时间: 2021
• 期刊: South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde
• 作者: Redinger S

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

对围产期抑郁的艾滋病毒阳性妇女进行综合心理和育儿干预的评估，以促进儿童发育并减少孕产妇抑郁：Insika Yomama 集群随机对照试验研究方案

• DOI: 10.21203/rs.3.rs-383359/v1
• 发表时间: 2021
• 作者: Rochat T

Antenatal depression and anxiety across pregnancy in urban South Africa

南非城市地区的产前抑郁症和怀孕期间的焦虑症

• DOI: 10.1016/j.jad.2020.08.010
• 发表时间: 2020
• 期刊: Journal of Affective Disorders
• 影响因子: 6.6
• 作者: Redinger S