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Behavioral Intervention

FOCUS-EC for Traumatic Stress

N/A
Waitlist Available
Led By Nastassia Hajal, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child must cohabitate with the parent/caregiver
Parent/caregiver must have access to internet and Webcam
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time 1 (baseline assessment) and time 2 (3-months post-baseline)
Awards & highlights

Study Summary

This trial looks at how parental emotional trauma can lead to ineffective parenting, and uses neurophysiological methods to identify potential biomarkers of stress and response to intervention.

Who is the study for?
This trial is for parents or legal guardians of children aged 3-6 who live together. The parent must have experienced trauma in their own childhood, speak English, and have internet with a webcam. It's not for those without these experiences, who don't want their child to participate, or if there are significant neurological issues or developmental delays in the child.Check my eligibility
What is being tested?
The study tests how parental traumatic stress affects parenting by using an educational website and a program called FOCUS-EC designed to help families cope with stress. Researchers will use EEG brain scans to understand emotional regulation and find markers of traumatic stress response.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like education programs and psychological assessments rather than drugs or medical procedures, traditional physical side effects are not expected; however, participants may experience emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time 1 (baseline assessment) and time 2 (3-months post-baseline)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time 1 (baseline assessment) and time 2 (3-months post-baseline) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in observed parenting behaviors during standardized parent-child interaction tasks
Change in posttraumatic stress disorder symptoms as measured by the Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5)
Change in self-reported parenting behaviors as measured by the Multidimensional Assessment of Parenting Scale (MAPS)
Secondary outcome measures
Change in Coping with Children's Negative Emotions Scale (CCNES)
Change in Emotion Regulation Questionnaire (ERQ)
Change in Eyberg Child Behavior Inventory
+7 more
Other outcome measures
Change in Parent Reflective Functioning Questionnaire
Change in Perth Alexithymia Questionnaire
Change in electroencephalography (EEG)-measured cortical alpha asymmetry
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Families Over-Coming Under Stress-Early Childhood Program (FOCUS-EC)Experimental Treatment1 Intervention
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.
Group II: Parenting Education WebsiteActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,521 Previous Clinical Trials
10,278,871 Total Patients Enrolled
Nastassia Hajal, PhDPrincipal InvestigatorUniversity of California, Los Angeles

Media Library

Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05264415 — N/A
Traumatic Stress Disorders Research Study Groups: Families Over-Coming Under Stress-Early Childhood Program (FOCUS-EC), Parenting Education Website
Traumatic Stress Disorders Clinical Trial 2023: Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC) Highlights & Side Effects. Trial Name: NCT05264415 — N/A
Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05264415 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are partaking in this trial?

"Affirmative, according to the information shared on clinicaltrials.gov, this medical research initiative is presently looking for participants. It was published online on October 6th 2021 and recently refreshed on February 28th 2022. A total of 60 individuals between 1 sites will be accepted into the trial."

Answered by AI

Are there still opportunities for interested individuals to participate in this research initiative?

"Affirmative. According to clinicaltrials.gov, the recruitment process for this trial is ongoing and began on October 6th 2021. The study has been modified as recently as February 28th 2022 and aims to enroll 60 individuals at a single location."

Answered by AI

What is the prime motive of this clinical investigation?

"The primary outcome for this clinical trial, which will be evaluated during an initial assessment and three months post-baseline, is the alteration of parenting behaviours in a standardized parent-child setting. Secondary outcomes encompass changes in emotion regulation strategies (taken from both the Emotion Regulation Questionnaire and Parental Emotion Regulation Inventory), as well as alterations to anxiety levels by way of measurements taken on Spence's Child Anxiety Scale - Preschool Version."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
University of California, Los Angeles (UCLA)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~4 spots leftby May 2024