Interrupting the Intergenerational Transmission of Traumatic Stress: Identifying Parental Targets for Intervention by Looking Under the Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Change in self-reported parenting behaviors as measured by the Multidimensional Assessment of Parenting Scale (MAPS)
研究概览
简要总结
Millions of U.S. parents have experienced trauma, putting them at risk for maladaptive parenting practices, which then confer vulnerabilities to their children. This study aims to enhance understanding of how parental emotional dysregulation associated with traumatic stress impedes effective parenting. The study employs neurophysiological methods (electroencephalogram; EEG) to address some of the challenges inherent in the study of emotion (particularly in trauma-exposed individuals) and to identify potential biomarkers of traumatic stress and response to intervention.
详细描述
This research study consists of a randomized controlled trial of 60 families of preschool-aged children in which a parent/caregiver has their own history of childhood interpersonal trauma or loss.
Parent/caregiver participants and their preschool-aged child will participate in two phases of assessment (baseline/Time 1 and follow-up/Time 2). Each phase of assessment will include parent/caregiver participant completion of self-report questionnaire measures, a parent-child interaction task (which will be video-recorded for later behavioral coding) and a parent EEG assessment. After the Time 1 (T1) assessments, participants will be randomized to either the FOCUS-Early Childhood Program group (n = 30; experimental group) or the parent education curriculum website group (n = 30; active comparator group).
The T2 assessment phase will begin at 3-months post-baseline. The FOCUS-EC Program is an 8-week program, so families should have completed the program by 3 months post-baseline. In the event that a family that was randomized to the FOCUS-EC Program group has not completed the program by the 3-month mark, the T2 assessment will be initiated once the program has been completed (up to 6 months post-baseline).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent/caregiver (must be legal guardian) of a 3- to 6-year-old child
- •Child must cohabitate with the parent/caregiver
- •Parent/caregiver participant must have experienced some form of interpersonal trauma during their own childhood (e.g., abuse, neglect, witnessing domestic violence)
- •Parent/caregiver must be English-speaking
- •Parent/caregiver must have access to internet and Webcam
排除标准
- •Does not meet inclusion criteria
- •Parent/legal guardian does not want the child to participate in the study
- •Significant neurological disorder (included in pre-screening protocol)
- •Active psychosis/mania (as assessed by staff)
- •Significant child developmental delays (as assessed by staff)
- •Families excluded from the study will be provided with a list of online and/or community resources.
研究组 & 干预措施
Families Over-Coming Under Stress-Early Childhood Program (FOCUS-EC)
FOCUS-EC is a trauma-informed, family-level, skill building program that provides developmental guidance, parent education, and key resilience skills that promote positive individual and family coping (including emotional regulation, problem solving, goal setting, communication, and management of trauma & loss reminders), which foster parent-child and family cohesion. It is delivered in approximately 8 weekly sessions (including approximately six 60-minute sessions with parent/caregivers only, and two 30-60 minute sessions with children and parent/caregivers together). Each session is structured with a check-in, review of the previous week's "home activity," new skills-based activity and discussion, selection of a new "home activity," and a closing check-out. FOCUS-EC promotes parenting skills and more cohesive family relationships in two key phases: 1) creating a family timeline and 2) enhancing parent-child interactions.
干预措施: Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC) (Behavioral)
Parenting Education Website
The Parenting Education Website includes information and high-quality parenting resources covering topics such as typical child development, common child reactions to family stress and transitions, play, positive parenting strategies, and the importance of self-care.
干预措施: Parenting Education Website (Other)
结局指标
主要结局
Change in self-reported parenting behaviors as measured by the Multidimensional Assessment of Parenting Scale (MAPS)
时间窗: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
The Multidimensional Assessment of Parenting Scale (MAPS) is a self-report questionnaire of parenting behaviors. This study will administer the 30 items corresponding to subscales that represent the following aspects of parenting behavior: * proactive parenting * positive reinforcement * warmth * supportiveness * hostility * lax control The scale is scored such that higher scores indicate a higher degree of that type of parenting (e.g., higher scores on the positive reinforcement subscale indicate greater use of positive reinforcement). Each subscale: Minimum possible score: 1 Maximum possible score: 5
Change in observed parenting behaviors during standardized parent-child interaction tasks
时间窗: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Coded based on previously established parent-child behavioral coding systems (Deater-Deckard, 2000; Deater-Deckard, Pylas, \& Petrill, 1997; Dix et al., 2004; Murphy, Boyd-Soissan, et al., 2017), including codes for positive parenting behaviors (e.g., praise, sensitivity, positive affect expressions), negative parenting behaviors (e.g., criticism, intrusiveness, harshness, negative affect expressions), and responses to children's negative emotion expressions (e.g., emotion coaching, validation, suppression, minimization).
Change in posttraumatic stress disorder symptoms as measured by the Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5)
时间窗: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
The Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5) is a well-established, 20-item questionnaire of posttraumatic stress symptoms. Higher scores indicate higher levels of posttraumatic stress symptoms. Minimum possible score: 0 Maximum possible score: 80
次要结局
- Change in Parental Feelings Inventory (PFI)(Time 1 (baseline assessment) and Time 2 (3-months post-baseline))
- Change in Patient Health Questionnaire-8 (PHQ-8)(Time 1 (baseline assessment) and Time 2 (3-months post-baseline))
- Change in Eyberg Child Behavior Inventory(Time 1 (baseline assessment) and Time 2 (3-months post-baseline))
- Change in Coping with Children's Negative Emotions Scale (CCNES)(Time 1 (baseline assessment) and Time 2 (3-months post-baseline))
- Change in Parenting Stress Index-Short Form 4(Time 1 (baseline assessment) and Time 2 (3-months post-baseline))
- Change in Preschool Feelings Checklist(Time 1 (baseline assessment) and Time 2 (3-months post-baseline))
- Change in Emotion Regulation Questionnaire (ERQ)(Time 1 (baseline assessment) and Time 2 (3-months post-baseline))
- Change in Parental Emotion Regulation Inventory-2 (PERI-2)(Time 1 (baseline assessment) and Time 2 (3-months post-baseline))
- Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7)(Time 1 (baseline assessment) and Time 2 (3-months post-baseline))
- Change in Spence Child Anxiety Scale - Preschool Version(Time 1 (baseline assessment) and Time 2 (3-months post-baseline))
研究者
Nastassia Hajal
Assistant Clinical Professor
University of California, Los Angeles