Clinical trial NCT06569303: Filipino Family Health Initiative 1.0
Official title: Virtual Positive Parenting Intervention to Promote Filipino Family Wellness: A Randomized Controlled Trial : Filipino Family Health Initiative 1.0
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Parenting
Keywords: Filipino Families
Incredible Years
Mental Health
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
name: University of Southern California
name: University of California, San Diego
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-08-26
Enrollment: 500
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to test the effectiveness of an online parenting program on Filipino parents living in California. The main aims are to:

* Test the effectiveness of the online Incredible Years® model of parent training and its impact on primary outcomes.
* Determine the impact of intervention engagement (i.e., higher attendance) on parenting practices and child behavior outcomes.
* Describe Intervention delivery and its online implementation in real-world community settings.

The study involves two phases:

* Phase 1: Participants will receive the Online Incredible Years® School Age Basic \& Advanced Parent Training Program (intervention) and complete parent-reported and child-reported measures at baseline, 3 months and 6 months.
* Phase 2: Parenting Group Leaders will each participate in one semi-structured interview to inform the sustainability of the intervention in real world community settings. Researchers will compare 250 Filipino families, half of which will receive the intervention and the other half will receive the American Academy of Pediatrics' Bright Futures handouts (control) and be placed on a 3-month waitlist for the IY parenting program. Both groups will be followed for a minimum of 6 months with follow- up assessments that include parent-report and child report measures.

Detailed description: Evidence-based parenting interventions provided in early childhood have proven to be effective in preventing the onset and escalation of child mental health disorders. The overall objective of the proposed research is to test the effectiveness of a parenting program (Incredible Years® School Age Advance and Basic Parent Training Program, IYP) in Filipino parents recruited from multiple community-based settings and its impact on trajectories of parenting practices, parenting stress, and child problem behavior. IYP is one of the best studied and most highly regarded parent training programs.

Through pilot studies funded by an National Institutes of Health (NIH) Mentored Patient-Oriented Research Career Development Award (K23) and an National Center for Advancing Translational Sciences (NCATS) Mentored Career Development Award (KL2) award, the investigators identified IYP as a community-identified solution for preventing behavioral health problems, demonstrated IYP efficacy in improving parenting practices and parenting stress in Filipino parents, and child problem behavior. This population was chosen because: 1) Filipinos are the third largest Asian population in the U.S. with the highest concentration living in Los Angeles; 2) Filipinos are exposed to multiple adversities, including immigration stress and relocation, loss of social status, and lower self-esteem, placing young children at risk for future behavioral and mental health problems; 3) U.S.-born Filipino youth exhibit higher rates of mental health problems than non-Hispanic whites and attain significantly lower levels of education than their foreign-born counterparts and other U.S.-born Asian American populations; and 4) Filipinos are less likely than non-Hispanic whites to participate in mental health and preventive care interventions.

The sample will include 500 individuals, 250 Filipino parent-child dyads. Data will be obtained using process evaluation tracking system and self-report instruments. The specific aim is to test the effectiveness of the Incredible Years model of parent training and its impact on parenting practices (primary outcome). It is hypothesized that 1) Parents will report and demonstrate improvements in parenting practices after IYP, as compared to baseline and to the control condition; 2) Parents in the experimental group will show more rapid improvement in parenting practices and these effects will be sustained over time compared to those in the control condition; and 3) Parents will report improvements in parenting stress, child problem behavior, such as internalizing, externalizing, and depressive symptoms (secondary outcomes) after IYP as compared to baseline and to the control condition.

Findings will contribute to the scientific literature on preventive and early intervention programs for children at high risk for future behavioral problems. The data will also provide important information to understand the processes underlying how IYP affects parenting practices and subsequent child problem behavior among Filipino families. The importance of this research rests on its potential to prevent behavioral health disparities in this understudied and high-risk population.

The investigators also aim to describe intervention delivery and its online implementation in real-world community settings. Research Question 1: What are the facilitators/barriers to implementing the intervention at multiple levels (consumer, staff/provider, community setting)? Research Question 2: What are the facilitators and barriers to sustaining the intervention during and after the study?

Eligibility criteria: Inclusion Criteria:

* Parent or legal guardian of at least one child 8-12 years of age
* Parent or legal guardian is of Filipino descent
* Parent or legal guardian and child are English speaking
* Pregnant women or legal guardians may be included if they have a child who meets the inclusion and exclusion criteria

Exclusion Criteria:

* Family plans to move out of the state of California within the next 6 months
* Family has previously participated in the Incredible Years (IY) curriculum
* Parent or legal guardian are not fluent in English
* Adults unable to consent or children unable to assent
* Prisoners

Note: All parent participants in the study are 18 years or older. Youth participants are 8-12 years old.

Primary outcomes:
measure: Parent Reported Positive Verbal Discipline
timeFrame: Baseline, 3 months, 6 months
measure: Child Reported Depression Symptoms
timeFrame: Baseline, 3 months, 6 months
measure: Child Reported Anxiety Symptoms
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Parent Reported Use of Physical Punishment
timeFrame: Baseline, 3 months, 6 months
measure: Parent Reported Change in Child Behavioral Problems
timeFrame: Baseline, 3 months, 6 months
measure: Parent Reported Child Anxiety
timeFrame: Baseline, 3 months, 6 months
measure: Parent Reported Child Depression
timeFrame: Baseline, 3 months, 6 months
measure: Parent Reported Child Resilience
timeFrame: Baseline, 3 months, 6 months
measure: Child Reported Child Resilience
timeFrame: Baseline, 3 months, 6 months
measure: Parenting Self Efficacy
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Kaiser Permanente Bernard J. Tyson School of Medicine
state: California
Study officials:
affiliation: Kaiser Permanente School of Medicine
name: Joyce R Javier, MD MPH MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Javier JR, Aguiling W, Cunanan P, Sepulveda A, Coffey DM, Castro J, Palinkas LA, Kipke MD, Mack WJ. Short-term outcomes from a pilot randomized controlled trial evaluating a virtual culturally adapted parenting intervention among Filipino parents of school-age children. Cultur Divers Ethnic Minor Psychol. 2025 Jan;31(1):124-137. doi: 10.1037/cdp0000616. Epub 2023 Oct 19.