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Intergenerational Transmission of Traumatic Stress

University of California, Los Angeles (UCLA) logo

University of California, Los Angeles (UCLA)

Status

Completed

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05264415
1K08HD097277-01A1 (U.S. NIH Grant/Contract)
KHD097277A

Details and patient eligibility

About

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.

Full 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).

Enrollment

65 patients

Sex

All

Ages

3+ years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

65 participants in 2 patient groups

Families Over-Coming Under Stress-Early Childhood Program (FOCUS-EC)
Experimental group
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.
Treatment:
Behavioral: Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC)
Parenting Education Website
Active Comparator group
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.
Treatment:
Other: Parenting Education Website

Trial contacts and locations

1

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Central trial contact

Patricia Lester, MD; Nastassia Hajal, PhD

Data sourced from clinicaltrials.gov

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