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DepressionFFHINCT06569303

Filipino Family Health Initiative 1.0

A study testing Incredible Years® School Age Basic Parent Training Program and American Academy of Pediatrics, Bright Futures Handouts in people with Depression and Anxiety, run by Kaiser Permanente at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 years and olderHealthy volunteers can take part
Conditions the study is for
Depression, Anxiety, Parenting
What is being tested?
Incredible Years® School Age Basic Parent Training Program and American Academy of Pediatrics, Bright Futures Handouts
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteUnited States
Study dates
15 Apr 2025to 31 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Joyce R Javier, MD MPH MS contact

626-862-7072

joyce.r.javier@kp.org

Lindsey R Thompson, MS, MPH contact

lindsey.r.thompson@kp.org

United States1 site, 1 recruiting
  • Kaiser Permanente Bernard J. Tyson School of Medicine

    Pasadena, California, 91101

    Jasmine Raymundo, MPH, 949-385-1427, kpsom-incrediblefamilies@kp.org

    Joyce R Javier, MD

    Recruiting

Other trials in United States

About this study

Official title: Virtual Positive Parenting Intervention to Promote Filipino Family Wellness: A Randomized Controlled Trial : Filipino Family Health Initiative 1.0

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.
Read more

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.
Read the 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?

Being tested
Incredible Years® School Age Basic Parent Training Program, American Academy of Pediatrics, Bright Futures Handouts
Keywords
Filipino Families, Incredible Years, Mental Health
Medical subject headings
Depression, Anxiety Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Incredible Years® School Age Basic Parent Training ProgramBehavioural

    The Incredible Years® School Age Basic Parent Training Program targets many of the proposed mechanisms and risk factors for internalizing distress in early childhood: harsh and unpredictable or critical parenting behaviors. Parents also learn cognitive strategies; such as self-praise, coping thoughts, how to challenge negative thoughts, and how to get support that they are encouraged to model for and teach their children. Finally, the participants learn how to be more positive and nurturing through academic, social and emotional coaching.

  • American Academy of Pediatrics, Bright Futures HandoutsBehavioural

    Written materials that include age-group specific tips on how parents can support their child's development and social and academic success.

Study groups in NCT06569303
Study groupRoleWhat they receive
InterventionExperimentalParents assigned to the intervention arm will receive the Incredible Years® School Age Basic \& Advanced Parent Training Program. It consists of twelve (12) 2-hour online workshops led by a certified peer coach in the Incredible Years Parent Training Series.
Receives: Behavioral: Incredible Years® School Age Basic Parent Training Program
ControlOtherParents assigned to the control arm will be emailed and mailed written parent education materials from the American Academy of Pediatrics called the Bright Futures handouts. The control group is offered the Incredible Years® School Age Basic \& Advanced Parent Training Program after a 3-month wait list period.
Receives: Behavioral: Incredible Years® School Age Basic Parent Training Program; Behavioral: American Academy of Pediatrics, Bright Futures Handouts

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parent Reported Positive Verbal Discipline

    Parenting practices will be assessed using scores from the Parent Practices Interview (PPI). The PPI asks questions regarding parenting styles and behavior management techniques. Questions are rated on a scale ranging from never to always

    Measured: Baseline, 3 months, 6 months

  2. Child Reported Depression Symptoms

    Child depression will be measured using the Child Depression Inventory (CDI). Each item in this self-report instrument includes a list of sentences that describe how children typically feel. Children are asked to pick out the sentence that best describes how they feel over the past 2 weeks.

    Measured: Baseline, 3 months, 6 months

  3. Child Reported Anxiety Symptoms

    Child anxiety will be measured using the Screen for Child Anxiety Related Emotional Disorders (SCARED). Screen includes a list of sentences that describe how people feel over the last 3 months. Answers are rated on a scale from 0 (not true) to 2 (very true or often true).

    Measured: Baseline, 3 months, 6 months

Secondary outcomes (7)
  1. Parent Reported Use of Physical Punishment

    Parent reported use of physical punishment will be assessed using scores from the Parent Practices Interview (PPI).

    The PPI asks questions regarding parenting styles and behavior management techniques. Questions are rated on a scale ranging from never to always.

    Measured: Baseline, 3 months, 6 months

  2. Parent Reported Change in Child Behavioral Problems

    Child problem behavior will be measured using scores from Child Behavior Checklist (CBCL). Parents describe their child's behavior within the past 6 months. Questions are rated on a scale from 0 (not true) to 2 (very true or often true). The CBCL screens for the following behaviors: Aggressive Behavior, Anxious/Depressed, Attention Problems, Rule-Breaking Behavior, Somatic Complaints, Social Problems, Thought Problems, Withdrawn/Depressed. Results for each subscale are presented as a percentile and T-score, with scores above 97th percentile considered as "clinical range" based on the Diagnostic and Statistical Manual of Mental Disorders (DSM)-V.

    Measured: Baseline, 3 months, 6 months

  3. Parent Reported Child Anxiety

    Parent reported child anxiety will be measured using scores from the Screen for Child Anxiety Related Disorders (SCARED). Screen includes a list of sentences that describe how people feel over the last 3 months. Answers are rated on a scale from 0 (not true) to 2 (very true or often true).

    Measured: Baseline, 3 months, 6 months

  4. Parent Reported Child Depression

    Parent Reported Child Depression will be measured using scores from the Children's Depression Inventory (CDI).

    Screen includes statements that describes observations of subject's child over the past 2 weeks. Answers are rated on a scale from 0 (not at all) to 3 (much or most of the time).

    Measured: Baseline, 3 months, 6 months

  5. Parent Reported Child Resilience

    Parent Reported Child Resilience will be measured using scores from the Child \& Youth Resilience Measure- Revised Person Most Knowledgeable Version (PMK-CYRM-R). Questions include statements designed to better understand how the subject's child copes with daily life. Answers are rated on a scale from 1( not at all) to 5 (a lot).

    Measured: Baseline, 3 months, 6 months

  6. Child Reported Child Resilience

    Child Reported Child Resilience will be measured using scores from the Child \& Youth Resilience Measure (CYRM-R).

    Questions include statements designed to better understand how the child copes with daily life. Answers are rated on a scale from 1( not at all) to 5 (a lot).

    Measured: Baseline, 3 months, 6 months

  7. Parenting Self Efficacy

    Parenting Self Efficacy will be measured using scores from the Parenting Sense of Competence (PSOC). Questions include agree/ disagree statements about perceived self efficacy and satisfaction with parenting. Answers are rated on a scale from 1( Strongly Disagree) to 6 (Strong Agree).

    Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start15 Apr 2025
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06569303
Sponsor's protocol ID
KPSOM-2189823
Other IDs
7R01MD017003
Acronym
FFHI
Status last verified
Jan 2026
First submitted
22 Aug 2024
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data will be provided to the NIH National Institute of Mental Health Data Archives (NDA) repository. The de-identified individual data will be shared with the NIH National Institute of Mental Health Data Archives (NDA) repository. Any information that could be used to identify you will be removed before any data is shared. NDA provides infrastructure for sharing research data, tools, methods, and analyses enabling collaborative science and discovery. De-identified human subjects data, harmonized to a common standard, are available to qualified researchers. The NDA makes available human subjects data collected from hundreds of research projects across many scientific domains. De-identified human subjects data, harmonized to a common standard, are available to qualified researchers.

Publications

  • 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.

    PubMed 37856386

Questions about this trial

What is this clinical trial studying?

A study testing Incredible Years® School Age Basic Parent Training Program and American Academy of Pediatrics, Bright Futures Handouts in people with Depression and Anxiety, run by Kaiser Permanente at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joyce R Javier, MD MPH MS (626-862-7072, joyce.r.javier@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parent Reported Positive Verbal Discipline (time frame: Baseline, 3 months, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06569303, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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