Differential DNA Methylation as a Function of a Parenting Intervention
2017年12月15日 更新者：Mary Dozier、University of Delaware
Differential DNA Methylation as a Function of a Parenting Intervention: A Randomized Clinical Trial
The aim of this study is to experimentally assess whether an early parenting intervention for maltreating parents results in differential epigenetic marking of children's genome, particularly of DNA associated with immune system functioning, obesity, and mental health.
研究概览
地位
完全的
条件
详细说明
This study assesses whether a 10-session intervention for maltreating parents effects the epigenome of young children who have experienced early maltreatment.
Families are randomly assigned to the experimental condition (Attachment and Biobehavioral Catch-Up) or a treatment control (Developmental Education for Families).
Biological samples and behavioral observations of parenting will be collected pre- and post- intervention.
Biological samples will be used to conduct whole genome analyses of differential DNA methylation that occur as a result of the intervention.
Behavioral observations of parent-child interactions will be used to assess the efficacy of the intervention in altering parenting behaviors.
研究类型
介入性
注册 (实际的)
44
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
6个月 至 2年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Parents will be considered potentially eligible if they have a child between the ages of 6 and 20 months and have a history of substantiated or unsubstantiated report of maltreatment or domestic violence. After obtaining informed consent, observational assessments of sensitivity will be conducted, allowing screening of parents with low levels of sensitivity (who are expected to benefit more from the intervention than others). Only those parents who have scores in the insensitive range will be included in the full study.
Exclusion Criteria:
- Children with known serious medical issues (e.g., cerebral palsy) will be excluded from the sample. Also, high-risk parents will be screened for sensitivity to ensure that they will benefit from the intervention. Only those who are screened as relatively insensitive (1-2 on a 5 point coding scale) will be included in the full study.
- If the primary caregiver loses custody of the child before completion of the project, the participant will be withdrawn from the study.
- If the primary caregiver is incarcerated before completion of the study, the subject will be withdrawn from the study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Attachment and Biobehavioral Catch-Up
|
Attachment and Biobehavioral Catch-up (ABC) is a 10-session, weekly intervention delivered in the family's home.
ABC addresses three primary issues.
First, young children who have experienced early adversity are especially in need of nurturance and parents who behave in synchronous ways and delight in them.
Next, when parents behave in frightening ways, it is difficult for children to look to them for reassurance when distressed.
This can be particularly difficult for children who have experienced early adversity.
Therefore, this intervention helps parents learn how to: 1) behave in nurturing ways when children are distressed; 2) behave in synchronous, delighted ways when children are not distressed; and 3) avoid behaving in frightening or intrusive ways.
Interventionists are provided with a manualized protocol, but tailor specific session content to each family's needs.
Sessions are videotaped, both for playback to families, and for supervision.
|
|
有源比较器：Developmental Education for Families
|
Developmental Education for Families (DEF) is a 10-session, weekly intervention delivered in the family's home.
DEF focuses on enhancing gross and fine motor skills, cognition and language development.
The age-based protocols (i.e., 6-24 months,) provide information about the developmental themes of focus for each week and suggest activities to enhance the target skills for that week.
However, the protocols do not provide a direct script with which to conduct the sessions.
Interventionists tailor the developmental program session to the needs of the child and family by considering the child's current gross, fine, cognitive and language skills and creatively preparing several activities that will address the session topics.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Whole Genome DNA Methylation
大体时间：from date of enrollment to 1 month after completing the intervention
|
from date of enrollment to 1 month after completing the intervention
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Parental Sensitivity
大体时间：On date of enrollment, each intervention session, and 1 month after completing the intervention
|
On date of enrollment, each intervention session, and 1 month after completing the intervention
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年12月9日
初级完成 (实际的)
2014年12月16日
研究完成 (实际的)
2017年2月10日
研究注册日期
首次提交
2017年12月12日
首先提交符合 QC 标准的
2017年12月12日
首次发布 (实际的)
2017年12月15日
研究记录更新
最后更新发布 (实际的)
2017年12月19日
上次提交的符合 QC 标准的更新
2017年12月15日
最后验证
2017年12月1日
更多信息
与本研究相关的术语
其他研究编号
- 511457
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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