Clinical trial NCT05908461: The Early Childhood Friendship Project - Phase 3
Official title: The Early Childhood Friendship Project: Testing Key Mechanisms and the Moderating Role of Physiological Reactivity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-06-18
Enrollment: 600
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* None

Primary outcomes:
measure: Observations of Physical Aggression (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)
timeFrame: Up to 12 weeks post-intervention completion.
measure: Observations of Prosocial Behavior (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)
timeFrame: Up to 12 weeks post-intervention completion.
measure: Observations of Relational Aggression (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)
timeFrame: Up to 12 weeks post-intervention completion.
measure: Observations of Physical Victimization (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)
timeFrame: Up to 12 weeks post-intervention completion.
measure: Observations of Relational Victimization (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)
timeFrame: Up to 12 weeks post-intervention completion.
measure: Dynamic Indicators of Basic Early Learning (DIBELS) - Sound Fluency
timeFrame: Up to 4 months post-intervention completion.
measure: Dynamic Indicators of Basic Early Learning (DIBELS) - Letter Naming Fluency
timeFrame: Up to 4 months post-intervention completion.
measure: Early Numeracy Skills: Set Comparison
timeFrame: Up to 4 months post-intervention completion.
measure: Early Numeracy Skills: One-to-One Counting
timeFrame: Up to 4 months post-intervention completion.
measure: Early Numeracy Skills: Verbal Counting
timeFrame: Up to 4 months post-intervention completion.
measure: Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Relational Victimization Subscale
timeFrame: An average of 12 months post-intervention completion.
measure: Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Physical Victimization Subscale
timeFrame: An average of 12 months post-intervention completion.
measure: Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Physical Victimization Subscale
timeFrame: Up to 12 weeks post-intervention completion.
measure: Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Relational Victimization Subscale
timeFrame: Up to 12 weeks post-intervention completion.
measure: Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Physical Victimization Subscale
timeFrame: Up to 4 months post-intervention completion.
measure: Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Relational Victimization Subscale
timeFrame: Up to 4 months post-intervention completion.
measure: Preschool Social Behavior Scale - Teacher Report (PSBS-TR): Physical Aggression Subscale
timeFrame: An average of 12 months post-intervention completion.
measure: Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Relational Aggression Subscale
timeFrame: An average of 12 months post-intervention completion.
measure: Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Prosocial Behavior Subscale
timeFrame: An average of 12 months post-intervention completion.
measure: Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Relational Aggression Subscale
timeFrame: Up to 12 weeks post-intervention completion.
measure: Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Physical Aggression Subscale
timeFrame: Up to 12 weeks post-intervention completion.
measure: Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Prosocial Behavior Subscale
timeFrame: Up to 12 weeks post-intervention completion.
measure: Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Physical Aggression Subscale
timeFrame: Up to 4 months post-intervention completion.
measure: Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Relational Aggression Subscale
timeFrame: Up to 4 months post-intervention completion.
measure: Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Prosocial Behavior Subscale
timeFrame: Up to 4 months post-intervention completion.
measure: MacArthur Health and Behavior Questionnaire (HBQ) - School Performance Subscale
timeFrame: Up to 12 weeks post-intervention completion.
measure: MacArthur Health and Behavior Questionnaire (HBQ) - School Performance Subscale
timeFrame: An average of 12 months post-intervention completion.
measure: MacArthur Health and Behavior Questionnaire (HBQ) - School Engagement Subscale
timeFrame: Up to 12 weeks post-intervention completion.
measure: MacArthur Health and Behavior Questionnaire (HBQ) - School Engagement Subscale
timeFrame: An average of 12 months post-intervention completion.
measure: Social Skills Rating Scale (SSRS)
timeFrame: An average of 12 months post-intervention completion.
measure: Social Skills Rating Scale (SSRS)
timeFrame: Up to 12 weeks post-intervention completion.
measure: Social Skills Rating Scale (SSRS)
timeFrame: Up to 4 months post-intervention completion.
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo, SUNY
state: New York
Study officials:
affiliation: University at Buffalo, SUNY
name: Jamie M Ostrov, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: