The Early Childhood Friendship Project - Phase 3
ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-6
SponsorState University of New York at Buffalo
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Early Childhood Friendship Project
BehavioralClassroom-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 social skills of the week.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Observations of Physical Aggression (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)
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).
Time frame
Up to 12 weeks post-intervention completion.2
Observations of Prosocial Behavior (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)
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).
Time frame
Up to 12 weeks post-intervention completion.3
Observations of Relational Aggression (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)
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).
Time frame
Up to 12 weeks post-intervention completion.4
Observations of Physical Victimization (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)
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).
Time frame
Up to 12 weeks post-intervention completion.Sponsors and contacts
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State University of New York at Buffalo
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov