Summary

Eligibility
for people ages 3 years and up (full criteria)
Location
at Los Angeles, California
Dates
study started
completion around
Principal Investigator
by Nastassia Hajal, PhD

Description

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.

Official Title

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

Details

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).

Keywords

Stress, Psychological, Stress Disorders, Traumatic, Emotion Regulation, Behavior, Child, Emotional Stress, Trauma, Psychological, Anxiety, Depression, Coping Skills, Parent-Child Relations, Parenting, Resilience, Families, Parents, Children, Preschooler, Intervention, Traumatic Stress Disorders, Psychological Stress, Psychological Trauma, Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC), Parenting Education Website, Families Over-Coming Under Stress-Early Childhood Program (FOCUS-EC)

Eligibility

You can join if…

Open to people ages 3 years and up

  • 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 CAN'T join if...

  • 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.

Location

  • University of California, Los Angeles (UCLA)
    Los Angeles California 90095 United States

Lead Scientist at UCLA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
Links
Sign up for this study
ID
NCT05264415
Study Type
Interventional
Participants
About 65 people participating
Last Updated