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临床试验/NCT04296734
NCT04296734已完成不适用

Effects of a Prenatal Depression Preventive Intervention on Parenting and Young Children's Self-Regulation and Functioning (EPIC)

Northwestern University1 个研究点 分布在 1 个国家目标入组 960 人开始时间: 2019年11月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
960
试验地点
1
主要终点
Maternal depressive symptoms

研究概览

简要总结

Poor parenting practices and compromised child self-regulation when a child is 2 ½ - 4 ½ years old are foundational in promoting their later healthy development and adaptive functioning. This project will test whether targeting depressive symptoms with a prenatal preventive intervention prevents disruptions in well-regulated parenting and child self-regulation known to affect families with depressed mothers. This project may have great benefit to society, as preventive interventions delivered prenatally have the potential to influence long-term trajectories of parenting practices and child development which, in turn, can chart a course for future child health and well-being.

详细描述

The proposed R01 project Effects of a Prenatal Depression Preventive Intervention on Parenting and Young Children's Self-Regulation and Functioning (EPIC) examines whether a prenatal depression prevention intervention-Mothers and Babies (MB)-improves parenting practices and child self-regulation through 54 months of age. The investigators build on an existing cluster randomized controlled trial that enrolled 874 diverse, low-income women from 36 home visiting (HV) programs. The investigators anticipate 598 of these women will be eligible for EPIC (489 intervention, 109 control) and the research team will enroll an additional 260 control participants as part of this R01, for a total sample of 858. The research team will also enroll 429 fathers. Perinatal depression is consistently linked to poor parenting practices and poor child self-regulation. This project builds on previous work that has demonstrated MB's effects on improving maternal mental health outcomes and will examine the intervention's longer-term impact on parenting and child self-regulation from 30-54 months of age. Intervention participants will have received the six-week MB intervention delivered in a group format in addition to usual HV services while control participants will have only received HV services. Data collection for the R01 includes maternal self-report with all 858 participants every six months, beginning at 30 months postpartum and continuing until 54 months postpartum. An intensive sub-study of parenting and child development will occur at 36, 42, and 48 months for a subset of 460 participants (230 intervention, 230 control). Paternal self-report surveys will occur at 30, 42, and 54 months. There are three specific aims. First, the investigators test the hypothesis that MB improves parenting and child self-regulatory skill acquisition through 54 months of age. The investigators will use intent-to-treat as well as propensity score adjusted analysis. Second, the investigators test hypotheses about the maternal mechanisms by which MB influences parenting and child self-regulation. The investigators hypothesize that MB intervention effects will be mediated by core skills targeted by MB-in particular, increased awareness of thoughts and feelings and increases in mood regulation-as these cognitive-behavioral skills are deficient in mothers with depressive symptoms and compromise mothers' ability to engage in parenting practices that promote young children's self-regulation. Third, the investigators will examine fathers' and other key sociodemographic variables' role in moderating the impact of MB on mother's parenting and the child's self-regulation. The public health significance and innovation of this project is substantial. Addressing maternal mental health has been identified as a highly impactful enhancement to HV programs. If, as expected, the investigators are able to generate a robust science base that precisely identifies mechanisms and outcomes impacted by the intervention in young children among our racially and ethnically diverse sample, HV programs currently using MB are likely to enhance their programmatic outcomes. Moreover, given the large number of HV programs that could adopt MB nationally, findings from this study can provide powerful data suggesting that MB become integrated into their core set of services.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Women enrolled in parent-study:
  • ≥ 16 years of age
  • ≤33 weeks' gestation upon referral
  • English or Spanish speaking
  • New Cohort:
  • English or Spanish speaking
  • ≥ 18 years of age
  • Have a child 18-30 months old at the time of recruitment
  • Partners of female study participants:
  • ≥ 18 years of age
  • English or Spanish speaking
  • Have contact with the child of one of the existing/new female participants

结局指标

主要结局

Maternal depressive symptoms

时间窗: Child age 30-54 months

Measured by the 16-item Quick Inventory of Depressive Symptomatology (QIDS). Total score ranges from 0-27. Scores between 0-5 (no depression); 6-10 (Mild Depression); 11-15 (Moderate); 16-20 ( Severe); 21+ (Very Severe) .

Parenting outcomes ) of parenting self-efficacy (SE) and Parenting Hostile Reactive Behavior (HRB)

时间窗: Child age 30-54 months

Measured by the Parental Cognitions and Conduct Toward the Infant Scale (PACOTIS). Scores range from 0-10. Higher mean scores indicate greater self-efficacy, hostile-reactive parenting, perceived parental impact, and parental overprotection

Child self-regulation outcomes

时间窗: Child age 30-54 months

Measured by the Early Childhood Behavior Questionnaire-Very Short Form (ECBQ-VS). Items indicated with an R on the items-by-scale list below are reverse-scored. Sum the scores for items receiving a numerical response. Negative Affect (12 items): 16,17,19,32,2,26,10,22,23,1,33,34R Surgency (12 items): 4,13,18,20,24,6,11,9,25,3,30,36 Effortful Control (12 items): 21,27,31,8,15,35,7,14R,12R,29,5,28 Effortful Control measured by the Multidimensional Assessment Profile of Disruptive Behavior Short Form (MAP-DB) Temper Loss Subscale. A sum of the 49 short-form items to indicate total Disruptive Behavior (DB); A sum of the 22 TL items (15+7) to indicate Temper Loss. The scale goes from 0 (never) to 5 (many times each day). Higher scores indicate higher levels of problems.

次要结局

  • Maternal mental health and cognitive-behavioral skills(Child age 30-54 months)
  • Parenting outcomes of parental positive affect, sensitive responsiveness, and verbalizations(Child age 36-48 months)
  • Child self-regulation outcomes(Child age 36-48 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Darius Tandon

Associate Professor, Department of Medical Social Sciences Co-Director, Center for Community Health

Northwestern University

研究点 (1)

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