Last reviewed · How we verify
NCT05908461: ECFP-3
The Early Childhood Friendship Project - Phase 3
NA trial testing Early Childhood Friendship Project in Healthy in 600 participants. Currently enrolling.
16 April 2027
Quick facts
| Lead sponsor | State University of New York at Buffalo |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 600 |
| Start date | 16 August 2023 |
| Primary completion | 16 April 2027 |
| Estimated completion | 16 April 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Early Childhood Friendship Project
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
State University of New York at Buffalo
Who can join
Adults 4 to 6, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05908461
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Healthy
Currently open trials in the same condition.
- NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
- NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
- NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
- NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
- NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting
Other State University of New York at Buffalo trials
Trials by the same sponsor.
- NCT07072767 — Hybrid Dissemination Study of A Digital-Analog Intervention to Increase Live Donor Kidney Transplantation · NA · not yet recruiting
- NCT07140848 — CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes · NA · not yet recruiting
- NCT07433959 — Neuromodulation to Improve Grasping Function After SCI · NA · not yet recruiting
- NCT07403539 — Speech Learning and Speech Production in Parkinson's Disease · NA · recruiting
- NCT05367362 — Minocycline Efficacy in Improving Neurological Outcome of Patients Who Undergo Endovascular Revascularization for Acute · Phase 2 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05908461 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by State University of New York at Buffalo
- Last refreshed: 3 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05908461.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing