The Early Childhood Friendship Project - Phase 3
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early Childhood Friendship Project.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 4 years — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Early Childhood Friendship Project: Testing Key Mechanisms and the Moderating Role of Physiological Reactivity
Overview
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.
Interventions
- Behavioral 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
Primary outcome measures
- Observations of Physical Aggression (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions) [Time frame: Up to 12 weeks post-intervention completion.]
- Observations of Prosocial Behavior (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions) [Time frame: Up to 12 weeks post-intervention completion.]
- Observations of Relational Aggression (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions) [Time frame: Up to 12 weeks post-intervention completion.]
- Observations of Physical Victimization (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions) [Time frame: Up to 12 weeks post-intervention completion.]
- Observations of Relational Victimization (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions) [Time frame: Up to 12 weeks post-intervention completion.]
- Dynamic Indicators of Basic Early Learning (DIBELS) - Sound Fluency [Time frame: Up to 4 months post-intervention completion.]
- Dynamic Indicators of Basic Early Learning (DIBELS) - Letter Naming Fluency [Time frame: Up to 4 months post-intervention completion.]
- Early Numeracy Skills: Set Comparison [Time frame: Up to 4 months post-intervention completion.]
- Early Numeracy Skills: One-to-One Counting [Time frame: Up to 4 months post-intervention completion.]
- Early Numeracy Skills: Verbal Counting [Time frame: Up to 4 months post-intervention completion.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University at Buffalo, SUNY — Buffalo
Identifiers
NCT: NCT05908461 · STUDY00004375 · 1R01HD105496-01A1