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Идёт набор NCT06569303

Filipino Family Health Initiative 1.0

Без фазы С лечением Depression Anxiety Parenting

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Incredible Years® School Age Basic Parent Training Program, American Academy of Pediatrics, Bright Futures Handouts.
Кому может быть актуально
Состояния в реестре: Depression, Anxiety, Parenting. Базовые параметры: от 8 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Virtual Positive Parenting Intervention to Promote Filipino Family Wellness: A Randomized Controlled Trial : Filipino Family Health Initiative 1.0

Обзор

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.

Подробное описание

Evidence-based parenting interventions provided in early childhood have proven to be effective in preventing the onset and escalation of child mental health disorders. The overall objective of the proposed research is to test the effectiveness of a parenting program (Incredible Years® School Age Advance and Basic Parent Training Program, IYP) in Filipino parents recruited from multiple community-based settings and its impact on trajectories of parenting practices, parenting stress, and child problem behavior. IYP is one of the best studied and most highly regarded parent training programs.

Through pilot studies funded by an National Institutes of Health (NIH) Mentored Patient-Oriented Research Career Development Award (K23) and an National Center for Advancing Translational Sciences (NCATS) Mentored Career Development Award (KL2) award, the investigators identified IYP as a community-identified solution for preventing behavioral health problems, 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 third largest Asian 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, 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 sample will include 500 individuals, 250 Filipino parent-child dyads. Data will be obtained using process evaluation tracking system and self-report instruments. The specific aim is to test the effectiveness of the Incredible Years model of parent training and its impact on parenting practices (primary outcome). It is hypothesized that 1) Parents will report and demonstrate improvements in parenting practices after IYP, as compared to baseline and to the control condition; 2) Parents in the experimental group will show more rapid improvement in parenting practices and these effects will be sustained over time compared to those in the control condition; and 3) Parents will report improvements in parenting stress, child problem behavior, such as internalizing, externalizing, and depressive symptoms (secondary outcomes) after IYP as compared to baseline and to the control condition.

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.

The investigators also aim to describe intervention delivery and its online implementation in real-world community settings. Research Question 1: What are the facilitators/barriers to implementing the intervention at multiple levels (consumer, staff/provider, community setting)? Research Question 2: What are the facilitators and barriers to sustaining the intervention during and after the study?

Вмешательства

  • Поведенческое 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; 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 thro
  • Поведенческое 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.

Первичные конечные точки

  • Parent Reported Positive Verbal Discipline [Срок оценки: Baseline, 3 months, 6 months]
  • Child Reported Depression Symptoms [Срок оценки: Baseline, 3 months, 6 months]
  • Child Reported Anxiety Symptoms [Срок оценки: Baseline, 3 months, 6 months]
Вторичные конечные точки (7)
  • Parent Reported Use of Physical Punishment [Срок оценки: Baseline, 3 months, 6 months]
  • Parent Reported Change in Child Behavioral Problems [Срок оценки: Baseline, 3 months, 6 months]
  • Parent Reported Child Anxiety [Срок оценки: Baseline, 3 months, 6 months]
  • Parent Reported Child Depression [Срок оценки: Baseline, 3 months, 6 months]
  • Parent Reported Child Resilience [Срок оценки: Baseline, 3 months, 6 months]
  • Child Reported Child Resilience [Срок оценки: Baseline, 3 months, 6 months]
  • Parenting Self Efficacy [Срок оценки: Baseline, 3 months, 6 months]

Критерии участия

Критерии включения

  • 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
  • Pregnant women or legal guardians may be included if they have a child who meets the inclusion and exclusion criteria

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Kaiser Permanente Bernard J. Tyson School of Medicine — Pasadena

Публикации

  • 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. PMID 37856386

Идентификаторы

NCT: NCT06569303 · KPSOM-2189823 · 7R01MD017003

Первоисточники (государственные реестры)

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