Intergenerational Transmission of Traumatic Stress

NCT05264415 | Completed

• 2 other identifiers: KHD097277A1K08HD097277-01A1
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Change in Emotion Regulation Questionnaire (ERQ)

  Time 1 (baseline assessment) and Time 2 (3-months post-baseline)

• Change in Parental Feelings Inventory (PFI)

  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 Coping with Children's Negative Emotions Scale (CCNES)

  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)

Other Outcomes (4)

• Change in electroencephalography (EEG)-measured cortical alpha asymmetry

  Time 1 (baseline assessment) and Time 2 (3-months post-baseline)

• Change in electroencephalography (EEG)-measured cortical functional connectivity

  Time 1 (baseline assessment) and Time 2 (3-months post-baseline)

• Change in Parent Reflective Functioning Questionnaire

  Time 1 (baseline assessment) and Time 2 (3-months post-baseline)

Study Arms (2)

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

EXPERIMENTAL

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)

Parenting Education Website

ACTIVE COMPARATOR

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

Interventions

Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC) BEHAVIORAL

Trauma-informed, family-centered, skill-building preventive intervention for families with preschool-aged children.

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

Parenting Education Website OTHER

A website providing parenting education resources in four primary domains relevant for families with preschool-aged children (parenting, child development, transitions, and self-care).

Parenting Education Website

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of California, Los Angeles (UCLA)

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Stress Disorders, Traumatic; Emotional Regulation; Child Behavior; Psychological Trauma; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Trauma and Stressor Related Disorders; Mental Disorders; Self-Control; Social Behavior

Study Officials

• Nastassia Hajal, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: March 3, 2022
• Study Start: October 6, 2021
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

US (1)