Parent-Infant Research Institute, Austin Health, 300 Waterdale Road, Heidelberg Heights, VIC, 3081, Australia.
Melbourne School of Psychological Sciences, University of Melbourne, Grattan Street, Parkville, VIC, 3010, Australia.
BMC Psychol. 2023 Aug 4;11(1):222. doi: 10.1186/s40359-023-01244-w.
Substantial evidence indicates that maternal depression during pregnancy (i.e., antenatal depression) is associated not only with maternal wellbeing but also with child emotional and behavioural development. Children of antenatally depressed women are at risk of emotional and behavioural problems, including internalising problems (e.g., anxiety and depression) and externalising problems (e.g., attention problems), that may last at least to adolescence. These enduring effects also constitute an enormous economic cost. Despite the seriousness of this problem, until recently there existed very few controlled studies evaluating whether active psychological treatment for antenatal depression can prevent adverse child outcomes. Our previous pilot randomised controlled trial (RCT) exploring the effect of cognitive behavioural therapy (CBT) for antenatal depression on child outcomes showed promising results. We aim to assess whether treating antenatal depression with an evidence-based 8-week structured CBT program can prevent or ameliorate adverse child developmental outcomes at 2 years of age.
Pregnant women ≤ 30 weeks gestation diagnosed with a depressive disorder are recruited and randomised to CBT or treatment as usual (TAU). The target sample size is 230 and the primary outcome measure is the infant Internalising scale of the Child Behaviour Checklist (CBCL) at 24 months of age. Secondary infant outcome measures at 24 months are the Externalising scale of the CBCL and the motor and cognitive development subscales of the Ages & Stages Questionnaire (ASQ-3). Additional secondary outcome measures are subscales of the Revised Infant Behaviour Questionnaire (IBQ-R), ASQ-3 and the ASQ-Socio-Emotional (ASQ-SE) at 3 and 12 months of age and the quality of mother-infant interaction at 3 and 24 months. Maternal measures, including demographic data, depression diagnosis, depressive and anxiety symptoms, perceived stress and parenting stress, are collected across all time points.
The trial is ongoing and recruitment was slowed due to the COVID-19 pandemic. If results suggest a beneficial effect of antenatal depression treatment on infant outcomes, the project could have repercussions for standard antenatal care, for maternal and infant health services and for preventing the intergenerational transmission of mental health disorders.
Australia and New Zealand Clinical Trials Register: ACTRN12618001925235 Date Registered: 27 November 2018.
大量证据表明，孕妇在怀孕期间的抑郁（即产前抑郁）不仅与母亲的健康有关，还与儿童的情绪和行为发展有关。产前抑郁妇女的孩子面临情绪和行为问题的风险，包括内化问题（如焦虑和抑郁）和外化问题（如注意力问题），这些问题可能至少持续到青春期。这些持久的影响也构成了巨大的经济成本。尽管这个问题很严重，但直到最近，几乎没有任何对照研究评估积极的心理治疗对产前抑郁是否可以预防儿童不良结局。我们之前的探索认知行为疗法（CBT）对产前抑郁儿童结局影响的试点随机对照试验（RCT）显示出了有希望的结果。我们旨在评估用循证的 8 周结构化 CBT 方案治疗产前抑郁是否可以预防或改善 2 岁时儿童发育不良的结果。
招募≤30 周妊娠并被诊断为抑郁障碍的孕妇，并将其随机分配到 CBT 或常规治疗（TAU）组。目标样本量为 230 人，主要结局测量指标是婴儿在 24 个月时的儿童行为检查表（CBCL）的内化量表。次要婴儿结局测量指标是 24 个月时的 CBCL 的外化量表和年龄与阶段问卷（ASQ-3）的运动和认知发展子量表。其他次要结局测量指标是婴儿行为问卷修订版（IBQ-R）、ASQ-3 和社会情绪问卷（ASQ-SE）的子量表，以及婴儿在 3 个月和 24 个月时的母婴互动质量。在所有时间点都收集了母亲的人口统计学数据、抑郁诊断、抑郁和焦虑症状、感知压力和育儿压力等数据。
该试验正在进行中，由于 COVID-19 大流行，招募速度放缓。如果结果表明产前抑郁治疗对婴儿结局有有益的影响，那么该项目可能会对标准产前护理、母婴健康服务以及预防精神障碍的代际传递产生影响。
澳大利亚和新西兰临床试验注册中心：ACTRN12618001925235 注册日期：2018 年 11 月 27 日。
