Clinical trial NCT05264415: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-03-03
Enrollment: 65
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Change in observed parenting behaviors during standardized parent-child interaction tasks
timeFrame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
measure: Change in self-reported parenting behaviors as measured by the Multidimensional Assessment of Parenting Scale (MAPS)
timeFrame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
measure: Change in posttraumatic stress disorder symptoms as measured by the Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5)
timeFrame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Secondary outcomes:
measure: Change in Emotion Regulation Questionnaire (ERQ)
timeFrame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
measure: Change in Parental Feelings Inventory (PFI)
timeFrame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
measure: Change in Parental Emotion Regulation Inventory-2 (PERI-2)
timeFrame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
measure: Change in Coping with Children's Negative Emotions Scale (CCNES)
timeFrame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
measure: Change in Patient Health Questionnaire-8 (PHQ-8)
timeFrame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
measure: Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7)
timeFrame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
measure: Change in Parenting Stress Index-Short Form 4
timeFrame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
measure: Change in Eyberg Child Behavior Inventory
timeFrame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
measure: Change in Preschool Feelings Checklist
timeFrame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
measure: Change in Spence Child Anxiety Scale - Preschool Version
timeFrame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Other outcomes:
measure: Change in electroencephalography (EEG)-measured cortical alpha asymmetry
timeFrame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
measure: Change in electroencephalography (EEG)-measured cortical functional connectivity
timeFrame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
measure: Change in Parent Reflective Functioning Questionnaire
timeFrame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
measure: Change in Perth Alexithymia Questionnaire
timeFrame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles (UCLA)
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Nastassia Hajal, PhD
role: PRINCIPAL_INVESTIGATOR
References: