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

世界上大多数艾滋病毒感染者生活在撒哈拉以南非洲（SSA），育龄妇女负担最重。在南非某些地区，在产前诊所就诊的妇女中，艾滋病毒阳性的比例高达35%。许多人是在怀孕期间接受艾滋病毒筛查时得到诊断的。许多艾滋病毒阳性的妇女在怀孕期间患有抑郁症；超过40%的人在筛查问卷上得分高于抑郁症的阈值，约23%的人符合诊断标准。抑郁症与抗逆转录病毒治疗依从性降低、就诊率低、自杀念头和纯母乳喂养率低有关。此外，围产期抑郁症对养育子女和儿童早期发展有负面影响。患有抑郁症的母亲所生的孩子在认知发育、行为和成长方面受到损害的风险更大，尤其是在面临社会经济劣势和缺乏支持的情况下。另一份文献也有新的证据表明，艾滋病毒与照料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治疗，以及提高关键的养育技能。特别是，抑郁的母亲经常需要帮助来敏感地回应和照顾他们的婴儿，以减轻抑郁对养育子女的负面影响。我们的目的是进行一项集群随机对照试验，以测试一项综合的家庭干预计划，该计划可以联合治疗抑郁症和提高父母的养育能力。在怀孕和产后期间进行的干预包括行为激活疗法（BA），以治疗抑郁症的症状，以及一个育儿方案，以提高母亲对婴儿的反应（CCD）。BA是一种结构化的治疗方法，侧重于增加有益的行为，改善情绪和生活质量，减少维持或加重抑郁的行为，如被动、逃避和沉思。它已经被证明和认知行为疗法一样有效。这种对行为而不是信仰的关注使BA在文化上被接受。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，非专业咨询师可以提供这种治疗。卫生组织/儿童基金会开发的共同发展模式已被证明，如果将其纳入现有的保健服务，可以改善低收入和中等收入国家的养育方式并促进儿童早期发育。我们已经增强了CCD，特别关注婴儿早期学习和注意力方面的育儿技能，特别是偶然反应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，在怀孕期间进行额外的面对面治疗，两次随访电话，并在产后提供育儿手册。随机对照试验将包括48组（每组24人），每组11名母亲（和婴儿）。这包括额外的25%，以考虑减员，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和艾滋病毒阳性）将在怀孕20至32周期间招募，并随访至孩子2岁。试验的主要目的是测试干预是否：1。改善儿童2岁时的认知发展。减少孕妇孕期和产后抑郁3。提高孕产妇对ART 4的依从性。提高纯母乳喂养率。提高母亲对婴儿线索的偶发反应以及认知和情感刺激的质量。促进儿童成长、行为和语言发展，减少胃肠道感染

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