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Behavioural Intervention
Early Childhood Friendship Project for Healthy Preschoolers (ECFP-3 Trial)
N/A
Recruiting
Led By Jamie M Ostrov, Ph.D.
Research Sponsored by State University of New York at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up an average of 12 months post-intervention completion.
Awards & highlights
Summary
This trial aims to test the impact of an Early Childhood Friendship Project (ECFP) on preschoolers' aggression, prosocial behavior, & school readiness, & examine how physiology and other factors affect success.
Who is the study for?
This trial is for children attending certain child care centers in the Buffalo region of New York who are planning to start kindergarten in the fall. There are no specific exclusion criteria, so it appears open to all eligible children at these centers.Check my eligibility
What is being tested?
The Early Childhood Friendship Project (ECFP) aims to improve kids' social skills and reduce aggression by having teachers implement a program with coaching support. The study will track changes over time, including after the kids start kindergarten.See study design
What are the potential side effects?
Since this intervention involves educational and behavioral techniques rather than medical or pharmaceutical treatments, traditional side effects are not applicable. However, there may be variations in individual responses to the program.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ an average of 12 months post-intervention completion.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~an average of 12 months post-intervention completion.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dynamic Indicators of Basic Early Learning (DIBELS) - Letter Naming Fluency
Dynamic Indicators of Basic Early Learning (DIBELS) - Sound Fluency
Early Numeracy Skills: One-to-One Counting
+16 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
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).
Group II: Control GroupActive Control1 Intervention
Participants will not receive the Early Childhood Friendship project intervention.
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,988 Previous Clinical Trials
2,682,923 Total Patients Enrolled
State University of New York at BuffaloLead Sponsor
249 Previous Clinical Trials
48,936 Total Patients Enrolled
Jamie M Ostrov, Ph.D.Principal InvestigatorUniversity at Buffalo, SUNY
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Eligibility Criteria:
This trial includes the following eligibility criteria:- N/A
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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