NCT06569303

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable depression

Timeline
23mo left

Started Apr 2025

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Apr 2025Mar 2028

First Submitted

Initial submission to the registry

August 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

August 22, 2024

Last Update Submit

January 30, 2026

Conditions

Keywords

Filipino FamiliesIncredible YearsMental Health

Outcome Measures

Primary Outcomes (3)

  • 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

    Baseline, 3 months, 6 months

  • 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.

    Baseline, 3 months, 6 months

  • 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).

    Baseline, 3 months, 6 months

Secondary Outcomes (7)

  • Parent Reported Use of Physical Punishment

    Baseline, 3 months, 6 months

  • Parent Reported Change in Child Behavioral Problems

    Baseline, 3 months, 6 months

  • Parent Reported Child Anxiety

    Baseline, 3 months, 6 months

  • Parent Reported Child Depression

    Baseline, 3 months, 6 months

  • Parent Reported Child Resilience

    Baseline, 3 months, 6 months

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Parents 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.

Behavioral: Incredible Years® School Age Basic Parent Training Program

Control

OTHER

Parents 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.

Behavioral: Incredible Years® School Age Basic Parent Training ProgramBehavioral: American Academy of Pediatrics, Bright Futures Handouts

Interventions

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

Control

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.

ControlIntervention

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Bernard J. Tyson School of Medicine

Pasadena, California, 91101, United States

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPersonal Satisfaction

Study Officials

  • Joyce R Javier, MD MPH MS

    Kaiser Permanente School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joyce R Javier, MD MPH MS

CONTACT

Lindsey R Thompson, MS, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 22, 2024

First Posted

August 26, 2024

Study Start

April 15, 2025

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Time Frame
Data will be shared with authorized users upon publication (via an NDA Study) or 1-2 years after the grant end date specified on the first Notice of Award, as defined in the applicable Data Sharing Terms and Conditions. Specific data used in a publication will be shared at the time of publication. All other data that are part of the principal investigator's final dataset as defined in the Data Sharing Terms and Conditions will be shared 2 years after the original project end date.
Access Criteria
Researchers studying parenting and child behavior outcomes.
More information

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