Filipino Family Health Initiative

• ClinicalTrials.gov Identifier: NCT04031170
• Recruitment Status: Recruiting
• First Posted: July 24, 2019
• Last Update Posted: July 24, 2019
• Sponsor: Children's Hospital Los Angeles
• Collaborator: Robert Wood Johnson Foundation
• Information provided by (Responsible Party): Joyce Javier, Children's Hospital Los Angeles

Study Description

Brief Summary:

The overall objective of this research is to test the effectiveness of a parenting program on Filipino parents living in Southern California. The sample will include 180 Filipino immigrant families, half of which will receive the Incredible Years® School Age Basic Parent Training Program (intervention) and the other half will receive the American Academy of Pediatrics' Bright Futures handouts (control).

Condition or disease	Intervention/treatment	Phase
Parenting; Family Relations; Education	Behavioral: Incredible Years® School Age Basic Parent Training Program; Other: American Academy of Pediatrics, Bright Futures Handouts	Not Applicable

Detailed Description:

The overall objective of the proposed research is to test the effectiveness of a parenting program (Incredible Years® School Age Basic Parent Training Program, IYP) on Filipino parents recruited from multiple community-based settings and its impact on trajectories of parenting practices, parenting stress, and child problem behavior.

Evidence-based parenting interventions provided in early childhood have proven to be effective in preventing the onset and escalation of child mental health disorders. IYP is one of the best-studied and most highly regarded parent training programs. As a result of pilot studies funded by a NIH K23 and a NCATS KL2 award, the investigators have identified IYP as a community-identified solution for preventing behavioral health disparities, 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 second largest immigrant 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 due to discrimination, 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 proposed study will be a randomized controlled trial involving 180 parents of children aged 8-12 years old. Parents will be randomly chosen to receive either a) a 12 - week parenting intervention called the Incredible Years (intervention group) or b) AAP bright future handouts with general parenting advice (control group). Due to limited funding, the investigators are unable to offer the Incredible Years intervention to the control group. Additionally, the parent's child and child's teacher will be surveyed to increase the validity of outcome data.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 540 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Filipino Family Health Initiative: The Incredible Years for Parents of School Age Children
• Actual Study Start Date: July 7, 2018
• Estimated Primary Completion Date: September 30, 2020
• Estimated Study Completion Date: September 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; Parents assigned to the intervention arm will receive the Incredible Years® School Age Basic 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; 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.
Control; 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.	Other: American Academy of Pediatrics, Bright Futures Handouts; Written materials that include age-group specific tips on how parents can support their child's development and social and academic success.; Other Name: Control

Outcome Measures

Primary Outcome Measures :

1. Change in parenting practices at 3 months in comparison to Baseline [ Time Frame: Baseline and 3 months ]
   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.
2. Change in child behavioral problems at 3 months in comparison to Baseline [ Time Frame: Baseline and 3 months ]
   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.
3. Change in parenting practices at 6 months in comparison to Baseline and 3-month surveys [ Time Frame: Baseline through 6 months ]
   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.
4. Change in child behavioral problems at 6 months in comparison to Baseline and 3-month surveys [ Time Frame: Baseline through 6 months ]
   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.
5. Effectiveness of parenting workshop (Intervention group only): Incredible Years Parent Satisfaction Questionnaire [ Time Frame: 3 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

NOTE: All parent and teacher participants in the study are 18 years or older. Youth participants are 8-12 years old. Since parents are the MAIN participants in this study (parents are randomized; students and teachers only fill out surveys), the age limits in this record are set for parents.

Inclusion Criteria:

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

Exclusion Criteria:

• if the parent plans to move out of the area 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

Contacts and Locations

Contacts

Contact: Joyce R Javier, MD, MPH, MS; 323-671-2093; jojavier@chla.usc.edu

Locations

United States, California

Filipino Cultural School; Recruiting

Cerritos, California, United States, 90703

Contact: Paolo Roca, BS 714-494-3090 proca@filipinoculturalschool.org

Sponsors and Collaborators

Children's Hospital Los Angeles

Robert Wood Johnson Foundation

Investigators

• Principal Investigator: Joyce R Javier, MD, MPH, MS; Children's Hospital Los Angeles, USC Keck School of Medicine

More Information

• Responsible Party: Joyce Javier, Assistant Professor, Clinical Pediatrics, Children's Hospital Los Angeles
• ClinicalTrials.gov Identifier: NCT04031170 History of Changes
• Other Study ID Numbers: CHLA-18-00066
• First Posted: July 24, 2019
• Last Update Posted: July 24, 2019
• Last Verified: July 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joyce Javier, Children's Hospital Los Angeles:

Filipino Families; Incredible Years