NCT04031170

Brief Summary

The overall objective of this research is to test the effectiveness of a parenting program on Filipino parents living in California. The sample will include 180 Filipino immigrant families, half of which will receive the Online Incredible Years® School Age Basic \& Advanced Parent Training Program (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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

July 7, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

7.5 years

First QC Date

December 12, 2018

Last Update Submit

April 12, 2025

Conditions

Keywords

Filipino FamiliesIncredible Years

Outcome Measures

Primary Outcomes (5)

  • Change in parenting practices at 3 months in comparison to Baseline

    Parenting practices will be assessed using scores from the Parenting Practices Inventory (PPI). The PPI asks questions regarding parenting styles and behavior management techniques. Questions are rated on a scale ranging from never to always. A total score is not calculated.

    Baseline and 3 months

  • Change in child behavioral problems at 3 months in comparison to Baseline

    Child problem behavior will be measured using scores from Child Behavior Checklist (CBCL). Parents describe their child's behavior within the past 6 months (from baseline and from 3 month time points). 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 DSM-V.

    Baseline and 3 months

  • Change in parenting practices at 6 months in comparison to Baseline and 3-month surveys

    Parenting practices will be assessed using scores from the Parenting Practices Inventory (PPI). The PPI asks questions regarding parenting styles and behavior management techniques. Questions are rated on a scale ranging from never to always. A total score is not calculated.

    Baseline through 6 months

  • Change in child behavioral problems at 6 months in comparison to Baseline and 3-month surveys

    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 DSM-V.

    Baseline through 6 months

  • Effectiveness of parenting workshop (Intervention group only): Incredible Years Parent Satisfaction Questionnaire

    Consumer satisfaction will be assessed through the Incredible Years Parent Satisfaction Questionnaire. Consumer satisfaction will be assessed through the Incredible Years Parent Satisfaction Questionnaire. The questionnaire is rated on a 7-point scale ranging from unsatisfied extremely satisfied. A total score is not calculated.

    3 months

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 classes led by Dean Coffey, a senior psychologist and 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.

Other: American Academy of Pediatrics, Bright Futures Handouts

Interventions

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 for themselves; 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, they learn how to be more positive and nurturing through academic, social and emotional coaching.

Intervention

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

Also known as: Control
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • is 18 years or older
  • identified as a parent of at least one Filipino or Half-Filipino child aged 8-12 years

You may not qualify if:

  • if the parent plans to move out of California during the next 9 months
  • parent does not speak English
  • has a target child with a developmental disability (Global Developmental Delay, GDD), Pervasive Developmental Disorder (PDD), or another significant developmental condition)
  • parent has completed Incredible Years school age program in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (2)

  • 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.

  • Macam SR, Mack W, Palinkas L, Kipke M, Javier JR. Evaluating an Evidence-Based Parenting Intervention Among Filipino Parents: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Feb 17;11(2):e21867. doi: 10.2196/21867.

Study Officials

  • Joyce R Javier, MD, MPH, MS

    Children's Hospital Los Angeles, USC Keck School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 12, 2018

First Posted

July 24, 2019

Study Start

July 7, 2018

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Individual participant data will be provided to the NIH National Institute of Mental Health Data Archives (NDA) repository. https://nda.nih.gov https://nda.nih.gov/nda/nimh-common-data-elements The NDA makes available human subjects data collected from hundreds of research projects across many scientific domains. 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.

Locations