Filipino Family Health Initiative

Parenting Clinical Trial

Official title:

Filipino Family Health Initiative: The Incredible Years for Parents of School Age Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04031170
• Other study ID #: CHLA-18-00066
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Children's Hospital Los Angeles
• Contact: Joyce R Javier, MD, MPH, MS
• Phone: 323-671-2093
• Email: jojavier[@]chla.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The overall objective of the proposed research is to test the effectiveness of a parenting program (Incredible Years® School Age Basic & Advanced 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) an online 12 - week parenting intervention called the Incredible Years (intervention group) or b) AAP bright future handouts with general parenting advice (control group). The control group will be offered the Incredible Years after a 3-month wait list period. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

NOTE: All parent 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; children 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 Filipino or Half-Filipino child aged 8-12 years

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Education
• Family Relations
• Parenting

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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