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Идёт набор NCT05233150

Child-Adult Relationship Enhancement in Primary Care (PriCARE) / Criando Niños Con CARIÑO (CARIÑO)

Без фазы С лечением Parent-Child Relations Child Maltreatment

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: PriCARE/CARIÑO.
Кому может быть актуально
Состояния в реестре: Parent-Child Relations, Child Maltreatment. Базовые параметры: 18 мес. — 99 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

Child-Adult Relationship Enhancement in Primary Care: Supporting Parents and Children

Обзор

The purpose of this study is evaluate the effectiveness of PriCARE/CARIÑO to reduce child maltreatment, improve parent-child interactions, and reduce harsh/neglectful parenting, parent stress, and child behaviors.

Подробное описание

The primary objective of this study is to evaluate the effectiveness of PriCARE/CARIÑO to reduce investigations of suspected Child Maltreatment (CM) by Child Protective Services (CPS), and CM risk as measured by the Brief Child Abuse Potential Inventory (BCAP).

The secondary objectives of this study are to measure the impact of PriCARE/CARIÑO on:

1. Parent-reported child behavior problems as assessed by the Eyberg Child Behavior Inventory (ECBI). 2. The quality of the parent-child relationship as measured by the Dyadic Parent-Child Interaction Coding System (DPICS). 3. Parenting stress as measured by the Parenting Stress Index-Short From (PSI). 4. Harsh parenting as measured by Conflict Tactics Scales, Parent-Child version (CTS) and the Parenting Scale (PS)

The investigators will perform a randomized controlled trial (RCT) of the effectiveness of the PriCARE/CARIÑO on objectives listed above among 2- to 6-year-old children and their parents at 3 Children's Hospital of Philadelphia (CHOP) Primary Care Centers and 10 pediatric clinics in North Carolina. The investigators intend to randomize 966 child-caregiver dyads (1932 subjects) to receive PriCARE/CARIÑO plus usual care (intervention group) and 966 child-parent dyads (1932 subjects) to receive usual care (control group). CM risk, parenting attitudes and skills, child behavior, and quality of the child-caregiver relationship will be measured at baseline and approximately 6-8 months after randomization for both the intervention and control groups. CPS investigations will be collected starting 4 months after randomization until the end of the study (up to 52 months).

Вмешательства

  • Поведенческое PriCARE/CARIÑO
    PriCARE/CARIÑO is a group caregiver training program designed to improve child behaviors, caregiver-child relationships, parenting capacity, and reduce caregiver stress. Sessions occur in the primary care clinic or virtually. PriCARE/CARIÑO uses the 3 P skills (Praise, Paraphrase and Point-out-Behavior). The training starts with skills on giving attention to children's positive, pro-social behaviors, while ignoring minor misbehaviors. The second part of the training teaches skills for giving eff

Первичные конечные точки

  • Child Protective Services Investigations from time 3 to time 5 [Срок оценки: 4 month after baseline (time 3) up to 52 months after baseline (time 5)]
  • Change in the Brief Child Abuse Potential Inventory (BCAP) score from time 1 to time 4 [Срок оценки: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
Вторичные конечные точки (12)
  • Change in the Eyberg Child Behavior Inventory (ECBI) intensity scale score from time 1 to time 4 [Срок оценки: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
  • Change in the Eyberg Child Behavior Inventory (ECBI) problem scale score from time 1 to time 4 [Срок оценки: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
  • Change in the number of child led play skills in the Dyadic Parent-Child Interaction Coding System (DPICS) from time 1 to time 4 [Срок оценки: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
  • Change in the number of non-child led skill in Dyadic Parent-Child Interaction Coding System (DPICS) score from time 1 to time 4 [Срок оценки: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
  • Change in the number of direct commands in Dyadic Parent-Child Interaction Coding System (DPICS) score from time 1 to time 4 [Срок оценки: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
  • Change in the number child's compliance with commands in Dyadic Parent-Child Interaction Coding System (DPICS) score from time 1 to time 4 [Срок оценки: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
  • Change in the Parenting Stress Index-Short Form (PSI) total score from time 1 to time 4 [Срок оценки: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
  • Change in the Parenting Stress Index-Short Form (PSI) Parental Distress subscale score from time 1 to time 4 [Срок оценки: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
  • Change in the Parenting Stress Index-Short Form (PSI) Parent-Child Dysfunctional Interaction subscale score from time 1 to time 4 [Срок оценки: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
  • Change in the Parenting Stress Index-Short Form (PSI) Difficult Child subscale score from time 1 to time 4 [Срок оценки: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
  • Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Nonviolent Discipline score from time 1 to time 4 [Срок оценки: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
  • Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Psychological Aggression score from time 1 to time 4 [Срок оценки: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]

Критерии участия

Критерии включения

  • Caregiver is age 18 years or older
  • Caregiver is English or Spanish Speaking
  • Caregiver is legal guardian of child subject
  • Caregiver provides informed consent
  • Caregiver is available to attend scheduled times of PriCARE/CARIÑO groups
  • Caregiver has cellular phone with text messaging capacity
  • Caregiver has appropriate technological tools and access to participate in virtual intervention
  • Child is between 18 months and 6 years old
  • Child receives care at participating primary care center
  • Child has Medicaid/Children's Health Insurance Program (CHIP)/no insurance
  • Child lives in North Carolina or Philadelphia

Критерии исключения

  • Caregiver or another caregiver in the household has previously participated in PriCARE/CARIÑO
  • Child has a cognitive functioning below 2-year-old level, as determined by the screening questions and/or the referring clinician
  • Child has a diagnosis of autism
  • Child is receiving individual behavioral health treatment or medication for a behavioral health problem

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 · 2 центра
  • University of North Carolina Chapel Hill — Chapel Hill
  • Children's Hospital of Philadelphia — Philadelphia

Публикации

  • Andom F, Wood JN, Jiang L, Lin FC, Schilling S. Bridging access and impact: primary care parenting intervention reduces early behavior problems in both virtual and in-person delivery modes. Front Pediatr. 2026 Feb 11;14:1709280. doi: 10.3389/fped.2026.1709280. eCollection 2026. PMID 41756184
  • Schilling S, Powell BJ, Stewart PW, Wood JN. Child Adult Relationship Enhancement in Primary Care (PriCARE): study design/protocol for a randomized trial of a primary care-based group parenting intervention to prevent child maltreatment. Trials. 2023 Feb 23;24(1):138. doi: 10.1186/s13063-022-07024-y. PMID 36823526

Идентификаторы

NCT: NCT05233150 · 20-2605 · 1R01HD103902-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗