The Early Childhood Friendship Project - Phase 3

Официальное название

The Early Childhood Friendship Project: Testing Key Mechanisms and the Moderating Role of Physiological Reactivity

Обзор

The purpose of this study is to assess the impact of the Early Childhood Friendship Project (ECFP) on changes in aggression/peer victimization subtypes, prosocial behavior, and social and academic competence with a teacher-implemented (with coaching) version of the program. Further, investigators will examine whether changes in executive functioning, emotion regulation, and hostile attribution biases indirectly account for the program effects. Investigators will test if physiological reactivity (skin conductance and respiratory sinus arrhythmia) serves as moderators of intervention effects. Data will be collected from 600 children (30 randomly assigned preschool classrooms) diverse in socioeconomic status and race/ethnicity. Investigators will use multiple methods (school-based observations, direct academic assessments, child interviews, physiological reactivity using two tasks, observer, caregiver, and teacher reports) to assess the efficacy of the program, hypothesized mechanisms, and role of physiology as a moderator of intervention effects. The duration of the effects will be tested at both 4 month and 12-month follow-up and will thus demonstrate the impact the program has on children's school readiness and transition to kindergarten. It is expected that preschool children randomly assigned to the ECFP intervention relative to the control condition will show significant and moderate reductions in physical and relational aggression/victimization at post-test and follow-up; the ECFP intervention group will also show increases in prosocial behavior, social competence, and academic competence, relative to the control group at post-test and follow-up (4-months at the end of preschool and 12 months after transitioning to kindergarten). Additionally, it is hypothesized that changes in executive functioning, emotion regulation, and hostile attribution biases will mediate treatment effects from baseline to respective follow-ups. It is anticipated that these hypothesis will be moderated by gender such that effects will be stronger for girls relative to boys. Finally, it is hypothesized that physiological reactivity will act as a moderator of intervention effects and of the executive functioning, emotion regulation, and hostile attribution biases mechanisms.

Вмешательства

• Поведенческое Early Childhood Friendship Project
  Classroom-based intervention where teachers will implement 8 10-minute puppet shows, 7 5-minute active gross motor activities to reinforce the social skill of the week, and 7 5-minute passive rehearsal activities such as making their own puppet and practicing the steps of the week. Up to three 1 hour in vivo behavioral reinforcement periods will occur per week and during these free play sessions teachers and the main puppet will use developmentally appropriate praise to reinforce the use of the

Первичные конечные точки

• Observations of Physical Aggression (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions) [Срок оценки: Up to 12 weeks post-intervention completion.]
• Observations of Prosocial Behavior (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions) [Срок оценки: Up to 12 weeks post-intervention completion.]
• Observations of Relational Aggression (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions) [Срок оценки: Up to 12 weeks post-intervention completion.]
• Observations of Physical Victimization (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions) [Срок оценки: Up to 12 weeks post-intervention completion.]
• Observations of Relational Victimization (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions) [Срок оценки: Up to 12 weeks post-intervention completion.]
• Dynamic Indicators of Basic Early Learning (DIBELS) - Sound Fluency [Срок оценки: Up to 4 months post-intervention completion.]
• Dynamic Indicators of Basic Early Learning (DIBELS) - Letter Naming Fluency [Срок оценки: Up to 4 months post-intervention completion.]
• Early Numeracy Skills: Set Comparison [Срок оценки: Up to 4 months post-intervention completion.]
• Early Numeracy Skills: One-to-One Counting [Срок оценки: Up to 4 months post-intervention completion.]
• Early Numeracy Skills: Verbal Counting [Срок оценки: Up to 4 months post-intervention completion.]

Критерии участия

Критерии включения

• A child is eligible if attending one of the participating child care centers in the greater Buffalo region of Western New York and planning to enter kindergarten in the fall.

Критерии исключения

• None

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

Фундаментальное исследование

Центры проведения

США · 1 центр

• University at Buffalo, SUNY — Buffalo

Идентификаторы

NCT: NCT05908461 · STUDY00004375 · 1R01HD105496-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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