Reducing Maternal Depression and Promoting Infant Social-Emotional Health & Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 368
- 试验地点
- 2
- 主要终点
- Landry Parent Child Interaction Rating Scales - Mother Negative Behavior
研究概览
简要总结
A mobile remote coaching program study to improve maternal mood and increase parenting practices that lead to better infant social-emotional and communication outcomes
详细描述
To address the life course needs of depressed mothers and their infants, brief, accessible, and integrated interventions that target both maternal depression and specific nurturing parent behaviors demonstrated to improve infant social-emotional communication outcomes are needed. In prior programmatic research, two separate web-based, remote coaching interventions for: (a) parent nurturing behaviors that improve infant outcomes (Baby-Net R34; R01) [13], and (b) maternal depression (Mom-Net R34; R01) [14] were developed. Compared to controls, the Baby-Net program demonstrated medium to large effects on observed nurturing parent behavior and on infant social-emotional competencies in the context of play [13] and in the context of book activities [15]. Mom-Net demonstrated low attrition and high levels of feasibility, program use, and satisfaction [14]. Compared to controls, Mom-Net participants demonstrated significant reductions in depression and improved preschool parenting behavior [14]. A substantial advantage of the mobile, remote coaching approach is that it overcomes multiple logistical barriers that often prevent low-income mothers from participating in community/home visiting treatment programs [2]. Thus, this prior research on web-based maternal depression and specific nurturing parenting behavior in infancy, provides a strong empirical basis for the Mom & Baby Net program. Investigators will rigorously test the merged Mom & Baby Net intervention effects with a total sample of 368 participants (184 mothers with depression and 184 infants) via a 2-arm, intent-to-treat, randomized controlled trial.
The start date of this grant-funded randomized controlled trial was September 1, 2016. Data collection is currently underway and scheduled to conclude in March 2022. Following IRB-approved pilot work, the randomized controlled trial was IRB- approved on November 17, 2017. Immediately following IRB approval, recruitment was initiated. Between February 15, 2018 and March 11, 2021, we successfully consented a total sample of 368 participants (184 women and 184 infants) into the randomized controlled trial. The sample is predominantly Black and socioeconomically disadvantaged.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Assessment coders and participants are naive to treatment condition
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Mother is 18 years of age
- •Mother speaks English
- •Mother lives in metro-Atlanta area
- •Mother has baby younger than 12 months of age
- •Mother has positive depression screen (PHQ2)
排除标准
- •Stressors that mother specifies at the time of screening that would interfere with study participation such as: maternal homelessness, mental or physical health condition (diagnosed with schizophrenia or treatment/medication for hallucinations/delusions), current inpatient treatment for mental health or substance abuse. Infant exclusion criteria include factors that could render research participation stressful, such as intensive treatment for a genetic or health condition or not in permanent legal guardian custody
结局指标
主要结局
Landry Parent Child Interaction Rating Scales - Mother Negative Behavior
时间窗: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Dichotomized rating scale used for coding observed parent and child behavior during semi-structured free play. Reported outcomes include: mother negative behavior (values = 0-1; higher scores = worse outcomes)
Indicator of Parent Child Interaction (IPCI) - Mother Maintain/Extend
时间窗: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Mother Maintain/Extend (values = 0-100%; higher = better outcomes);
Indicator of Parent Child Interaction (IPCI) - Child Positive Social
时间窗: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Child Positive Social (values = 0-100%; higher = better outcomes);
Landry Parent Child Interaction Rating Scales - Mother Positive Behavior
时间窗: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Rating scale used for coding observed parent and child behavior during semi-structured free play. Reported outcomes include: mother positive behavior (values = 4-20; higher scores = better outcomes);
PHQ9
时间窗: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Depression symptoms; Patient Health Questionnaire-9; values = 0-27; higher scores = worse outcome
Landry Parent Child Interaction Rating Scales - Child Positive/Engagement Behavior
时间窗: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Rating scale used for coding observed parent and child behavior during semi-structured free play. Reported outcomes include: child positive/engagement behavior (values = 2-10; higher scores = better outcomes)
Indicator of Parent Child Interaction (IPCI) - Child Engagement
时间窗: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Child Engagement (values = 0-100%; higher = better outcomes)
Knowledge of Infant Social-Emotional Development and Promotion
时间窗: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Rating scale used to assess understanding of the concepts of infant social-emotional behavior and its promotion by caregivers, assessing both definitional and applied concept knowledge; values = 0-28 higher scores = better outcomes
Indicator of Parent Child Interaction (IPCI) - Mother Overall Positive
时间窗: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Mother Overall Positive (values = 0-100%; higher = better outcomes)
次要结局
未报告次要终点
研究者
Kathleen Baggett
Associate Professor
Georgia State University