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Intergenerational Transmission of Traumatic Stress

Primary Purpose

Stress, Psychological, Stress Disorders, Traumatic, Emotion Regulation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC)
Parenting Education Website
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress, Psychological focused on measuring Resilience, Families, Parents, Children, Preschooler, Intervention

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, Los Angeles (UCLA)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Families Over-Coming Under Stress-Early Childhood Program (FOCUS-EC)

Parenting Education Website

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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
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

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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

Full Information

First Posted
October 26, 2021
Last Updated
May 9, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05264415
Brief Title
Intergenerational Transmission of Traumatic Stress
Official Title
Interrupting the Intergenerational Transmission of Traumatic Stress: Identifying Parental Targets for Intervention by Looking Under the Skin
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Stress Disorders, Traumatic, Emotion Regulation, Behavior, Child, Emotional Stress, Trauma, Psychological, Anxiety, Depression, Coping Skills, Parent-Child Relations, Parenting
Keywords
Resilience, Families, Parents, Children, Preschooler, Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Families Over-Coming Under Stress-Early Childhood Program (FOCUS-EC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Parenting Education Website
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC)
Intervention Description
Trauma-informed, family-centered, skill-building preventive intervention for families with preschool-aged children.
Intervention Type
Other
Intervention Name(s)
Parenting Education Website
Intervention Description
A website providing parenting education resources in four primary domains relevant for families with preschool-aged children (parenting, child development, transitions, and self-care).
Primary Outcome Measure Information:
Title
Change in observed parenting behaviors during standardized parent-child interaction tasks
Description
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 Frame
Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Title
Change in self-reported parenting behaviors as measured by the Multidimensional Assessment of Parenting Scale (MAPS)
Description
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 Frame
Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Title
Change in posttraumatic stress disorder symptoms as measured by the Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5)
Description
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 Frame
Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Secondary Outcome Measure Information:
Title
Change in Emotion Regulation Questionnaire (ERQ)
Description
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 Frame
Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Title
Change in Parental Feelings Inventory (PFI)
Description
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 Frame
Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Title
Change in Parental Emotion Regulation Inventory-2 (PERI-2)
Description
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 Frame
Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Title
Change in Coping with Children's Negative Emotions Scale (CCNES)
Description
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 Frame
Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Title
Change in Patient Health Questionnaire-8 (PHQ-8)
Description
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 Frame
Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Title
Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7)
Description
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 Frame
Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Title
Change in Parenting Stress Index-Short Form 4
Description
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 Frame
Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Title
Change in Eyberg Child Behavior Inventory
Description
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 Frame
Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Title
Change in Preschool Feelings Checklist
Description
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 Frame
Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Title
Change in Spence Child Anxiety Scale - Preschool Version
Description
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 Frame
Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Other Pre-specified Outcome Measures:
Title
Change in electroencephalography (EEG)-measured cortical alpha asymmetry
Description
EEG will be used to examine parent/caregiver alpha asymmetry in the frontal and parietal cortices during several tasks: - Resting baseline tasks: 4 minutes of eyes open 4 minutes of eyes closed - Explicit emotion tasks: Participants passively view images of children Participants are asked to pay attention to and modulate their emotions while viewing images of children Participants engage in a task of executive functioning (Go/No-Go paradigm) that uses photos of children's facial emotion expression as stimuli - Implicit emotion task: Participants view photos of children's facial emotion expressions and are asked to categorize them by gender
Time Frame
Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Title
Change in electroencephalography (EEG)-measured cortical functional connectivity
Description
EEG will be used to examine parent/caregiver functional connectivity between the frontal and parietal cortices during several tasks: - Resting baseline tasks: 4 minutes of eyes open 4 minutes of eyes closed - Explicit emotion tasks: Participants passively view images of children Participants are asked to pay attention to and modulate their emotions while viewing images of children Participants engage in a task of executive functioning (Go/No-Go paradigm) that uses photos of children's facial emotion expression as stimuli - Implicit emotion task: Participants view photos of children's facial emotion expressions and are asked to categorize them by gender
Time Frame
Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Title
Change in Parent Reflective Functioning Questionnaire
Description
The Parent Reflective Functioning Questionnaire is a self-report questionnaire measure of parental reflective functioning. The questionnaire consists of 18 items corresponding to subscales that represent the following aspects of reflective functioning: Pre-mentalizing Certainty about Mental States Interest and Curiosity in Mental States The scale is scored such that higher scores indicate a higher degree of that type of reflective functioning (e.g., higher scores on the Certainty about Mental States subscale indicate greater certainty about infant mental states). Minimum possible score: 1 Maximum possible score: 7
Time Frame
Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Title
Change in Perth Alexithymia Questionnaire
Description
The Perth Alexithymia Questionnaire is a 24-item self-report questionnaire measure of alexithymia, with higher scores indicating higher levels of alexithymia. Minimum possible score: 24 Maximum possible score: 168
Time Frame
Time 1 (baseline assessment) and Time 2 (3-months post-baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nastassia Hajal, PhD
Phone
310-794-6073
Email
nhajal@mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Lester, MD
Phone
310-794-9584
Email
PLester@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nastassia Hajal, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nastassia Hajal, PhD
Phone
310-794-6073
Email
NHajal@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Patricia Lester, MD
Phone
310-794-9584
Email
NHajal@mednet.ucla.edu

12. IPD Sharing Statement

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Intergenerational Transmission of Traumatic Stress

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