Intergenerational Transmission of Traumatic Stress

Depression Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

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

• NCT number: NCT05264415
• Study type: Interventional
• Source: University of California, Los Angeles
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 6, 2021
• Completion date: May 30, 2024