Optimizing Social-Emotional-Communication Development in Infants of Mothers With Depression: Protocol for a Randomized Controlled Trial of a Mobile Intervention Targeting Depression and Responsive Parenting.
Optimizing Social-Emotional-Communication Development in Infants of Mothers With Depression: Protocol for a Randomized Controlled Trial of a Mobile Intervention Targeting Depression and Responsive Parenting.
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DOI：
10.2196/31072
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发表时间：
2021-08-18
影响因子：
1.7
通讯作者：
Feil EG
中科院分区：
文献类型：
--
作者：
Baggett KM;Davis B;Sheeber L;Miller K;Leve C;Mosley EA;Landry SH;Feil EG
产后抑郁症会干扰母亲参与有效改善婴儿社会情绪和社会沟通结果的干预措施。在减少母亲抑郁和促进父母介导的优化婴儿社会情感和社会沟通能力的实践方面，缺乏综合干预措施。针对母亲抑郁症的干预措施往往与父母介导的干预措施分开。为了解决抑郁母亲及其婴儿的生命历程需求，我们需要针对母亲抑郁和特定父母实践的简短、可获取和综合干预措施，以改善婴儿的社会情感和社会沟通轨迹。本研究的目的是评估移动互联网干预的效果，母婴网，远程指导，改善母亲的情绪和促进父母的做法，优化婴儿的社会情绪和社会沟通的发展。这是一项两组随机对照意向治疗试验。主要结局包括母亲抑郁症状和观察到的父母和婴儿行为。通过直接观察评估和标准化问卷来测量结果。样本是从美国南部一个大城市的城市中心招募的。研究于2017年开始招募，2020年结束。参与者是抑郁症状加重的生母，年龄在18岁或以上，并且有一个不到12个月大的婴儿的监护权。筛查时的排除标准包括产妇无家可归或住在收容所，住院精神健康或药物滥用治疗，或产妇或婴儿接受严重精神或身体疾病的治疗，这些疾病会妨碍有意义的研究参与。这项由拨款资助的随机对照试验（RCT）开始日期为2016年9月1日。数据收集正在进行中。在机构审查委员会（IRB）批准的试点工作之后，RCT于2017年11月17日获得了IRB的批准。内部审查委员会批准后立即开始招聘。在2018年2月15日至2021年3月11日期间，我们成功地招募了184名妇女及其婴儿进入RCT。样本主要是非裔美国人，处于社会经济劣势。数据收集计划于2022年3月结束。我们预计，相对于注意力控制条件，其重点是围绕母亲抑郁和婴儿发育里程碑的教育，并采用匹配的技术和指导结构，母婴网络干预中的母亲将经历更大的抑郁减少，并在敏感和反应性的父母实践中获得收益，他们的婴儿将在社会情感和社会沟通行为方面表现出更大的收益。ClinicalTrials.gov NCT03464630;https://clinicaltrials.gov/ct2/show/NCT03464630 derr1 - 10.2196/31072
Postpartum depression interferes with maternal engagement in interventions that are effective in improving infant social-emotional and social-communication outcomes. There is an absence of integrated interventions with demonstrated effectiveness in both reducing maternal depression and promoting parent-mediated practices that optimize infant social-emotional and social-communication competencies. Interventions targeting maternal depression are often separate from parent-mediated interventions. To address the life course needs of depressed mothers and their infants, we need brief, accessible, and integrated interventions that target both maternal depression and specific parent practices shown to improve infant social-emotional and social-communication trajectories. The aim of this study is to evaluate the efficacy of a mobile internet intervention, Mom and Baby Net, with remote coaching to improve maternal mood and promote parent practices that optimize infant social-emotional and social-communication development. This is a two-arm, randomized controlled intent-to-treat trial. Primary outcomes include maternal depression symptoms and observed parent and infant behaviors. Outcomes are measured via direct observational assessments and standardized questionnaires. The sample is being recruited from the urban core of a large southern city in the United States. Study enrollment was initiated in 2017 and concluded in 2020. Participants are biological mothers with elevated depression symptoms, aged 18 years or older, and who have custody of an infant less than 12 months of age. Exclusion criteria at the time of screening include maternal homelessness or shelter residence, inpatient mental health or substance abuse treatment, or maternal or infant treatment of a major mental or physical illness that would hinder meaningful study participation. The start date of this grant-funded randomized controlled trial (RCT) was September 1, 2016. Data collection is ongoing. Following the institutional review board (IRB)–approved pilot work, the RCT was approved by the IRB on November 17, 2017. Recruitment was initiated immediately following IRB approval. Between February 15, 2018, and March 11, 2021, we successfully recruited a sample of 184 women and their infants into the RCT. The sample is predominantly African American and socioeconomically disadvantaged. Data collection is scheduled to be concluded in March 2022. We anticipate that relative to the attention control condition, which is focused on education around maternal depression and infant developmental milestones with matching technology and coaching structure, mothers in the Mom and Baby Net intervention will experience greater reductions in depression and gains in sensitive and responsive parent practices and that their infants will demonstrate greater gains in social-emotional and social-communication behavior. ClinicalTrials.gov NCT03464630; https://clinicaltrials.gov/ct2/show/NCT03464630 DERR1-10.2196/31072