The Early Childhood Friendship Project: Testing Key Mechanisms and the Moderating Role of Physiological Reactivity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Observations of Relational Aggression (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Control Group
Participants will not receive the Early Childhood Friendship project intervention.
Intervention Group
Participants will receive the Early Childhood Friendship project intervention (8x10-min puppet shows, 7x5-min gross motor activities7x5-min passive activities, up to 3x1-hour in-vivo behavioral reinforcement periods).
干预措施: Early Childhood Friendship Project (Behavioral)
结局指标
主要结局
Observations of Relational Aggression (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)
时间窗: Up to 12 weeks post-intervention completion.
Relational aggression will be assessed via focal child sampling with continuous recording observations for each participating child. Each observation is 10 minutes for up to 8 separate observations (i.e., frequency counts divided by number of sessions out of 8 sessions).
Observations of Relational Victimization (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)
时间窗: Up to 12 weeks post-intervention completion.
Relational victimization will be assessed via focal child sampling with continuous recording observations for each participating child. Each observation is 10 minutes for up to 8 separate observations (i.e., frequency counts divided by number of sessions out of 8 sessions).
Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Physical Victimization Subscale
时间窗: Up to 4 months post-intervention completion.
Research assistant observers will complete the PPVM-T-R physical victimization to assess physical victimization. Raw scores are 4-20 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of physical victimization.
Early Numeracy Skills: Verbal Counting
时间窗: Up to 4 months post-intervention completion.
Early numeracy will be assessed using the task verbal counting. In this task, a child is asked to count as high as possible until the child makes a mistake or correctly counts up to 100. A child's score is a single score based on correct counting out of 100. Scores range from 1-7, with higher scores indicating stronger performance.
Dynamic Indicators of Basic Early Learning (DIBELS) - Letter Naming Fluency
时间窗: Up to 4 months post-intervention completion.
Letter naming fluency will be measured using the DIBELS - Letter Naming Fluency measure. Scores on this measure range from 0 to 110, with higher scores indicating greater performance.
Observations of Physical Aggression (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)
时间窗: Up to 12 weeks post-intervention completion.
Physical aggression will be assessed via focal child sampling with continuous recording observation for each participating child. Each observation is 10 minutes for up to 8 separate observations (i.e., frequency counts divided by number of sessions out of 8 sessions).
Dynamic Indicators of Basic Early Learning (DIBELS) - Sound Fluency
时间窗: Up to 4 months post-intervention completion.
Sound fluency will be measured using the DIBELS - Sound Fluency measure. Scores are calculated as the correct initial sounds per minute, with higher scores indicating greater performance on this measure.
Early Numeracy Skills: Set Comparison
时间窗: Up to 4 months post-intervention completion.
Early numeracy will be assessed using the task set comparisons. In this activity, a child is presented with four sets of dots representing different amounts and asked which has the most or fewest dots. A child's score is a sum of correct responses. Scores range from 0-6, with higher scores indicating stronger performance.
Early Numeracy Skills: One-to-One Counting
时间窗: Up to 4 months post-intervention completion.
Early numeracy will be assessed using the task one-to-one counting. In this task, a child is presented with a set of dots and asked to count the set. A child's score is sum of correct responses. Scores range from 0 to 5, with higher scores indicating stronger performance.
Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Prosocial Behavior Subscale
时间窗: Up to 4 months post-intervention completion.
Research assistant observers will complete the PSBS-TR prosocial behavior subscale to assess prosocial behavior. Raw scores are 4-20 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of physical aggression.
Observations of Prosocial Behavior (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)
时间窗: Up to 12 weeks post-intervention completion.
Prosocial behavior will be assessed via focal child sampling with continuous recording observations for each participating child. Each observation is 10 minutes for up to 8 separate observations (i.e., frequency counts divided by number of sessions out of 8 sessions).
Observations of Physical Victimization (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)
时间窗: Up to 12 weeks post-intervention completion.
Physical victimization will be assessed via focal child sampling with continuous recording observations for each participating child. Each observation is 10 minutes for up to 8 separate observations (i.e., frequency counts divided by number of sessions out of 8 sessions).
Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Relational Victimization Subscale
时间窗: Up to 4 months post-intervention completion.
Research assistant observers will complete the PPVM-T-R relational victimization subscale to assess relational victimization. Raw scores are 4-20 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of physical victimization.
Preschool Social Behavior Scale - Teacher Report (PSBS-TR): Physical Aggression Subscale
时间窗: An average of 12 months post-intervention completion.
Teachers will complete the PSBS-TR physical aggression subscale to assess physical aggression. Raw scores are 6-30 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of physical aggression.
Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Physical Aggression Subscale
时间窗: Up to 4 months post-intervention completion.
Research assistant observers will complete the PSBS-TR physical aggression subscale to assess physical aggression. Raw scores are 6-30 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of physical aggression.
MacArthur Health and Behavior Questionnaire (HBQ) - School Engagement Subscale
时间窗: An average of 12 months post-intervention completion.
Teachers will complete the HBQ school engagement subscale to assess school engagement. Raw scores range from 0-16, with average scores on this measure ranging from 0-2, and with higher scores indicating higher levels of school engagement.
Social Skills Rating Scale (SSRS)
时间窗: Up to 4 months post-intervention completion.
Research assistant observers will complete this standard measure of social skills. Raw scores range from 0 to 60, with average scores on this measure ranging from 0-2, and with higher scores indicating higher levels of social skills.
Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Relational Aggression Subscale
时间窗: Up to 4 months post-intervention completion.
Research assistant observers will complete the PSBS-TR relational aggression subscale to assess relational aggression. Raw scores are 6-30 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of relational aggression.
MacArthur Health and Behavior Questionnaire (HBQ) - School Performance Subscale
时间窗: An average of 12 months post-intervention completion.
Teachers will complete the HBQ school performance subscale to assess academic competence. Raw scores range from 5-25, with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of academic competence.
次要结局
未报告次要终点
研究者
Jamie M. Ostrov, Ph.D.
Professor of Psychology, Clinical Area Head, Director of Clinical Training
State University of New York at Buffalo