Filipino Family Health Initiative 1.0
NCT Number: NCT06569303
Acronym: FFHI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression|Anxiety|Parenting
Interventions: BEHAVIORAL: Incredible Years® School Age Basic Parent Training Program|BEHAVIORAL: American Academy of Pediatrics, Bright Futures Handouts
Sponsor: Kaiser Permanente
Collaborators: Children's Hospital Los Angeles|University of Southern California|University of California, San Diego|National Institute on Minority Health and Health Disparities (NIMHD)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-10-01
Completion Date: 2029-03-31

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 immigrant 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.

Primary Outcome Measures: 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 Outcome Measures: 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., Baseline, 3 months, 6 months|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., Baseline, 3 months, 6 months|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)., Baseline, 3 months, 6 months|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)., Baseline, 3 months, 6 months|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)., Baseline, 3 months, 6 months|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)., Baseline, 3 months, 6 months|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)., Baseline, 3 months, 6 months