Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
65 participants
INTERVENTIONAL
2021-10-06
2024-11-04
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Families Over-Coming Under Stress-Early Childhood Program (FOCUS-EC)
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.
Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC)
Trauma-informed, family-centered, skill-building preventive intervention for families with preschool-aged children.
Parenting Education Website
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.
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).
Interventions
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Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC)
Trauma-informed, family-centered, skill-building preventive intervention for families with preschool-aged children.
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
3 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of California, Los Angeles
OTHER
Responsible Party
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Nastassia Hajal
Assistant Clinical Professor
Principal Investigators
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Nastassia Hajal, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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University of California, Los Angeles (UCLA)
Los Angeles, California, United States
Countries
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Other Identifiers
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KHD097277A
Identifier Type: -
Identifier Source: org_study_id