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临床试验/NCT04241913
NCT04241913撤回不适用

A Randomized Controlled Trial to Improve Biobehavioral Regulation Among High-Adversity Mothers and Young Children

Tulane University4 个研究点 分布在 1 个国家开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
4
主要终点
Parent RSA

研究概览

简要总结

This study will evaluate whether the intervention, Mom Power, improves the self-regulation of mothers with a history of trauma and their children. The central hypothesis is that the intervention will shift behavioral and physiological self-regulation in mothers, children, and dyads to mitigate psychopathology risk.

详细描述

Adverse childhood experiences (ACEs) are significant risk factors for psychopathology across the lifespan - risks that extend to the next generation, likely transmitted through both biological and behavioral pathways. Biobehavioral self-regulation and parenting are key candidates for transmission and potential points of intervention. However, nearly all intervention research takes a one-generation approach, measuring outcomes in the individual adult or child in treatment. Additionally, very little research has examined biomarkers of self-regulation in parents or children following treatment, and no known research has examined these processes in parents and young children simultaneously across treatment to explore bidirectional effects. There is a critical need to specify targets of two-generation interventions among high-adversity families to decrease intergenerational transmission of mental illness. The objective of this RCT is to determine whether Mom Power, an evidence-based two generation intervention for mothers with histories of trauma, enhances physiological and behavioral self-regulation in mothers and young children, testing mechanisms and examining bidirectional effects. The central hypothesis is that the intervention will shift behavioral and physiological (Respiratory Sinus Arrhythmia) self-regulation in mothers, children, and dyads to mitigate psychopathology risk. Three specific aims are proposed: 1) Examine intervention effects on children's biobehavioral self-regulation and psychopathology; 2) Examine intervention effects on mothers' biobehavioral self-regulation, psychopathology, and parenting behavior; and 3) Examine intergenerational change processes, including shifts in dyadic physiological and behavioral synchrony as well as bidirectional influences between mother and child self-regulation.

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
None

盲法说明

No masking

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Participants in this study must include a mother-child dyad. There is inclusion and

排除标准

  • for both mother and child.
  • Inclusion Criteria:
  • For moms: Mothers must be female, the biological mother, have an ACE score of 3 or more, speak English, and be 18 years or older.
  • For children: Children must be between the ages of 2 and
  • Exclusion Criteria:
  • For mothers: No pacemaker or self-reported heart condition; no active maternal substance abuse or psychosis on screeners (Brown & Rounds, 1995; Degenhardt, Hall, Korten, & Jablensky, 2005).
  • For children: No parent report of diagnosis of autism or global development delay, no parent report of pacemaker or heart condition

结局指标

主要结局

Parent RSA

时间窗: Within 6 weeks of treatment group completion; approximately 4 months

Parent self-regulation will be assessed physiologically with RSA baseline and RSA change during a parent-child dyadic task (Skowron et al., 2013); derived from electrocardiogram (ECG) collected using Mindware Technologies ambulatory mobile recorders during 1) 2-minute resting baseline; 2) a dyadic interaction task. ECG signals will be synchronized at acquisition with video and processed offline using Mindware software; research assistants will visually inspect for missing or erroneously identified R-peaks. Using spectral analysis of interbeat intervals, high-frequency heart rate variability will be extracted to quantify RSA within frequency bandwidths associated with respiration (.15-.40 for mothers; .24-1.04 for children), processed in 1-minute epochs averaged across tasks, and log-transformed.

Child RSA

时间窗: Within 6 weeks of treatment group completion; approximately 4 months

Child self-regulation will be assessed physiologically with RSA baseline and RSA change during a parent-child dyadic task (Skowron et al., 2013); derived from electrocardiogram (ECG) collected using Mindware Technologies ambulatory mobile recorders during 1) 2-minute resting baseline; 2) a dyadic interaction task. ECG signals will be synchronized at acquisition with video and processed offline using Mindware software; research assistants will visually inspect for missing or erroneously identified R-peaks. Using spectral analysis of interbeat intervals, high-frequency heart rate variability will be extracted to quantify RSA within frequency bandwidths associated with respiration (.15-.40 for mothers; .24-1.04 for children), processed in 1-minute epochs averaged across tasks, and log-transformed.

次要结局

  • Parent psychopathology(Within 6 weeks of treatment group completion; approximately 4 months)
  • Child Behavioral Self-Regulation, observational(Within 6 weeks of treatment group completion; approximately 4 months)
  • Sensitive parenting behavior(Within 6 weeks of treatment group completion; approximately 4 months)
  • Parenting behavior(Within 6 weeks of treatment group completion; approximately 4 months)
  • Parent mental representation(Within 6 weeks of treatment group completion; approximately 4 months)
  • Dyadic synchrony - physiological(Within 6 weeks of treatment group completion; approximately 4 months)
  • Parent emotion regulation(Within 6 weeks of treatment group completion; approximately 4 months)
  • Child Behavior - teacher report(Within 6 weeks of treatment group completion; approximately 4 months)
  • Parent self-efficacy(Within 6 weeks of treatment group completion; approximately 4 months)
  • Child Behavior - parent report(Within 6 weeks of treatment group completion; approximately 4 months)
  • Dyadic synchrony - observational(Within 6 weeks of treatment group completion; approximately 4 months)
  • Child Behavioral Self-Regulation, parent report(Within 6 weeks of treatment group completion; approximately 4 months)

研究者

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

Sarah Gray

Assistant Professor of Psychology, Clinical Professor of Psychiatry & Behavioral Sciences, Principal Investigator

Tulane University

研究点 (4)

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