Intergenerational Transmission of Traumatic Stress

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Interrupting the Intergenerational Transmission of Traumatic Stress: Identifying Parental Targets for Intervention by Looking Under the Skin

Conditions
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Anxiety, Stress, Psychological, Stress Disorders, Traumatic, Emotion Regulation, Behavior, Child, Emotional Stress, Trauma, Psychological, Depression, Coping Skills, Parent-Child Relations, Parenting

Intervention / Treatment
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* Behavioral: Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC)
* Other: Parenting Education Website


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Families Over-Coming Under Stress-Early Childhood Program (FOCUS-EC)<br>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. | Behavioral: Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC)<br>* Trauma-informed, family-centered, skill-building preventive intervention for families with preschool-aged children.<br>|
| Active Comparator: Parenting Education Website<br>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. | Other: Parenting Education Website<br>* A website providing parenting education resources in four primary domains relevant for families with preschool-aged children (parenting, child development, transitions, and self-care).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in observed parenting behaviors during standardized parent-child interaction tasks | 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). | Time 1 (baseline assessment) and Time 2 (3-months post-baseline) | 
| Change in self-reported parenting behaviors as measured by the Multidimensional Assessment of Parenting Scale (MAPS) | 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 | Time 1 (baseline assessment) and Time 2 (3-months post-baseline) | 
| Change in posttraumatic stress disorder symptoms as measured by the Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5) | 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 | Time 1 (baseline assessment) and Time 2 (3-months post-baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Emotion Regulation Questionnaire (ERQ) | The Emotion Regulation Questionnaire (ERQ) is a 10-item self-report questionnaire that assesses emotion regulation strategies of cognitive reappraisal and expressive suppression, with higher scores indicating greater use of those strategies. Minimum possible score: 1 Maximum possible score: 7 | Time 1 (baseline assessment) and Time 2 (3-months post-baseline) | 
| Change in Parental Feelings Inventory (PFI) | The Parental Feelings Inventory (PFI) is a 31-item self-report questionnaire that assesses parents' experience of specific emotions in the parenting context (Bradley et al., 2013). Higher scores represent greater experience of each type of emotion in the parenting role within the past month. Minimum possible score: 1 Maximum possible score: 7 | Time 1 (baseline assessment) and Time 2 (3-months post-baseline) | 
| Change in Parental Emotion Regulation Inventory-2 (PERI-2) | The Parental Emotion Regulation Inventory-2 (PERI-2) is a self-report questionnaire that assesses coping and emotion regulation strategies used within the parenting context (Lorber et al., 2017). The scale includes 23 items corresponding to subscales that represent the following aspects of emotion regulation: reappraisal suppression capitulation escape The scale is scored such that higher scores indicate a higher degree of that type of strategy (e.g., higher scores on the reappraisal subscale indicate greater use of reappraisal). Minimum possible score: 1 Maximum possible score: 7 | Time 1 (baseline assessment) and Time 2 (3-months post-baseline) | 
| Change in Coping with Children's Negative Emotions Scale (CCNES) | The Coping with Children's Negative Emotions Scale (CCNES) is an 82-item self-report questionnaire that assesses parents' responses to children's displays of negative emotions (e.g., expressive encouragement, problem solving, punishment, minimization). Higher scores reflect higher use of that type of response (e.g., higher score on expressive encouragement subscale indicates higher use of expressive encouragement responses). Minimum possible score: 1 Maximum possible score: 7 | Time 1 (baseline assessment) and Time 2 (3-months post-baseline) | 
| Change in Patient Health Questionnaire-8 (PHQ-8) | The Patient Health Questionnaire-8 (PHQ-8) is a well-established, 8-item scale of depression symptoms, with higher total scores indicating higher levels of depression symptoms. Minimum possible score: 0 Maximum possible score: 24 | Time 1 (baseline assessment) and Time 2 (3-months post-baseline) | 
| Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7) | The Generalized Anxiety Disorder-7 Questionnaire (GAD-7) is a well-established, 7-item scale of anxiety symptoms, with higher total scores indicating higher levels of anxiety symptoms. Minimum possible score: 0 Maximum possible score: 21 | Time 1 (baseline assessment) and Time 2 (3-months post-baseline) | 
| Change in Parenting Stress Index-Short Form 4 | The Parenting Stress Index-Short Form 4 (PSI-SF) is a 36-item self-report questionnaire of three dimensions of parenting stress (parental distress, parent-child dysfunctional interaction, and difficult child). Higher scores indicate higher levels of parenting stress. Subscales: Minimum possible score: 12 Maximum possible score: 60 Total Score: Minimum possible score: 36 Maximum possible score: 180 | Time 1 (baseline assessment) and Time 2 (3-months post-baseline) | 
| Change in Eyberg Child Behavior Inventory | The Eyberg Child Behavior Inventory (ECBI) is a 36-item parent/caregiver-report questionnaire measure of children's behavior problems that obtains information about the frequency of problem behaviors (Intensity subscale; higher scores indicate greater intensity) and whether or not the behavior is problematic for the parent (Problem subscale; higher scores indicate greater problem). Behavior intensity: Minimum possible score: 36 Maximum possible score: 252 Problem behavior: Minimum possible score: 0 Maximum possible score: 36 | Time 1 (baseline assessment) and Time 2 (3-months post-baseline) | 
| Change in Preschool Feelings Checklist | The Preschool Feelings Checklist is a 16-item parent/caregiver-report questionnaire measure of children's depressive symptoms. Higher scores indicate higher depression symptoms. Minimum possible score: 0 Maximum possible score: 16 | Time 1 (baseline assessment) and Time 2 (3-months post-baseline) | 
| Change in Spence Child Anxiety Scale - Preschool Version | The Spence Child Anxiety Scale - Preschool Version is a 34-item parent/caregiver-report questionnaire measure of children's anxiety symptoms. Higher scores indicate higher anxiety symptoms. Minimum possible score: 0 Maximum possible score: 112 | Time 1 (baseline assessment) and Time 2 (3-months post-baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parents, Resilience, Families, Children, Preschooler, Intervention