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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05264415
• Other study ID #: KHD097277A
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 6, 2021
• Est. completion date: May 30, 2024

Study information

• Verified date: March 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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.

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

Intervention

Behavioral:
• Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC)
Trauma-informed, family-centered, skill-building preventive intervention for families with preschool-aged children.

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

Locations

Country	Name	City	State
United States	University of California, Los Angeles (UCLA)	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in electroencephalography (EEG)-measured cortical alpha asymmetry	EEG will be used to examine parent/caregiver alpha asymmetry in the frontal and parietal cortices during several tasks: - Resting baseline tasks: 4 minutes of eyes open; 4 minutes of eyes closed; - Explicit emotion tasks: Participants passively view images of children; Participants are asked to pay attention to and modulate their emotions while viewing images of children; Participants engage in a task of executive functioning (Go/No-Go paradigm) that uses photos of children's facial emotion expression as stimuli; - Implicit emotion task: Participants view photos of children's facial emotion expressions and are asked to categorize them by gender	Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Other	Change in electroencephalography (EEG)-measured cortical functional connectivity	EEG will be used to examine parent/caregiver functional connectivity between the frontal and parietal cortices during several tasks: - Resting baseline tasks: 4 minutes of eyes open; 4 minutes of eyes closed; - Explicit emotion tasks: Participants passively view images of children; Participants are asked to pay attention to and modulate their emotions while viewing images of children; Participants engage in a task of executive functioning (Go/No-Go paradigm) that uses photos of children's facial emotion expression as stimuli; - Implicit emotion task: Participants view photos of children's facial emotion expressions and are asked to categorize them by gender	Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Other	Change in Parent Reflective Functioning Questionnaire	The Parent Reflective Functioning Questionnaire is a self-report questionnaire measure of parental reflective functioning. The questionnaire consists of 18 items corresponding to subscales that represent the following aspects of reflective functioning: Pre-mentalizing; Certainty about Mental States; Interest and Curiosity in Mental States; The scale is scored such that higher scores indicate a higher degree of that type of reflective functioning (e.g., higher scores on the Certainty about Mental States subscale indicate greater certainty about infant mental states).; Minimum possible score: 1 Maximum possible score: 7	Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Other	Change in Perth Alexithymia Questionnaire	The Perth Alexithymia Questionnaire is a 24-item self-report questionnaire measure of alexithymia, with higher scores indicating higher levels of alexithymia.; Minimum possible score: 24 Maximum possible score: 168	Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Primary	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)
Primary	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)
Primary	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	Change in Emotion Regulation Questionnaire (ERQ)	The Emotion Regulation Questionnaire (ERQ) is a 10-item self-report questionnaire that assesses emotion regulation strategies of cognitive reappraisal and expressive suppression, with higher scores indicating greater use of those strategies.; Minimum possible score: 1 Maximum possible score: 7	Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Secondary	Change in Parental Feelings Inventory (PFI)	The Parental Feelings Inventory (PFI) is a 31-item self-report questionnaire that assesses parents' experience of specific emotions in the parenting context (Bradley et al., 2013). Higher scores represent greater experience of each type of emotion in the parenting role within the past month.; Minimum possible score: 1 Maximum possible score: 7	Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Secondary	Change in Parental Emotion Regulation Inventory-2 (PERI-2)	The Parental Emotion Regulation Inventory-2 (PERI-2) is a self-report questionnaire that assesses coping and emotion regulation strategies used within the parenting context (Lorber et al., 2017). The scale includes 23 items corresponding to subscales that represent the following aspects of emotion regulation: reappraisal; suppression; capitulation; escape; The scale is scored such that higher scores indicate a higher degree of that type of strategy (e.g., higher scores on the reappraisal subscale indicate greater use of reappraisal).; Minimum possible score: 1 Maximum possible score: 7	Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Secondary	Change in Coping with Children's Negative Emotions Scale (CCNES)	The Coping with Children's Negative Emotions Scale (CCNES) is an 82-item self-report questionnaire that assesses parents' responses to children's displays of negative emotions (e.g., expressive encouragement, problem solving, punishment, minimization). Higher scores reflect higher use of that type of response (e.g., higher score on expressive encouragement subscale indicates higher use of expressive encouragement responses).; Minimum possible score: 1 Maximum possible score: 7	Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Secondary	Change in Patient Health Questionnaire-8 (PHQ-8)	The Patient Health Questionnaire-8 (PHQ-8) is a well-established, 8-item scale of depression symptoms, with higher total scores indicating higher levels of depression symptoms.; Minimum possible score: 0 Maximum possible score: 24	Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Secondary	Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7)	The Generalized Anxiety Disorder-7 Questionnaire (GAD-7) is a well-established, 7-item scale of anxiety symptoms, with higher total scores indicating higher levels of anxiety symptoms.; Minimum possible score: 0 Maximum possible score: 21	Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Secondary	Change in Parenting Stress Index-Short Form 4	The Parenting Stress Index-Short Form 4 (PSI-SF) is a 36-item self-report questionnaire of three dimensions of parenting stress (parental distress, parent-child dysfunctional interaction, and difficult child). Higher scores indicate higher levels of parenting stress.; Subscales: Minimum possible score: 12 Maximum possible score: 60; Total Score: Minimum possible score: 36 Maximum possible score: 180	Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Secondary	Change in Eyberg Child Behavior Inventory	The Eyberg Child Behavior Inventory (ECBI) is a 36-item parent/caregiver-report questionnaire measure of children's behavior problems that obtains information about the frequency of problem behaviors (Intensity subscale; higher scores indicate greater intensity) and whether or not the behavior is problematic for the parent (Problem subscale; higher scores indicate greater problem).; Behavior intensity: Minimum possible score: 36 Maximum possible score: 252; Problem behavior: Minimum possible score: 0 Maximum possible score: 36	Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Secondary	Change in Preschool Feelings Checklist	The Preschool Feelings Checklist is a 16-item parent/caregiver-report questionnaire measure of children's depressive symptoms. Higher scores indicate higher depression symptoms.; Minimum possible score: 0 Maximum possible score: 16	Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Secondary	Change in Spence Child Anxiety Scale - Preschool Version	The Spence Child Anxiety Scale - Preschool Version is a 34-item parent/caregiver-report questionnaire measure of children's anxiety symptoms. Higher scores indicate higher anxiety symptoms.; Minimum possible score: 0 Maximum possible score: 112	Time 1 (baseline assessment) and Time 2 (3-months post-baseline)