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Recruiting NCT07017010

NCT07017010 Optimizing Phonological Awareness Learning in Prekindergarten and Kindergarten to Improve Later Reading and Spelling

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Clinical Trial Summary
NCT ID NCT07017010
Status Recruiting
Phase —
Sponsor Ohio State University
Condition Reading Difficulties
Study Type INTERVENTIONAL
Enrollment 720 participants
Start Date 2025-09-12
Primary Completion 2029-07

Eligibility & Interventions

Sex All sexes
Min Age 4 Years
Max Age 9 Years
Study Type INTERVENTIONAL
Interventions
phonemic awareness intervention (PA)phonological sensitivity + phonemic awareness intervention (PSPA)delayed onset phonemic awareness intervention (DPA)

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 720 participants in total. It began in 2025-09-12 with a primary completion date of 2029-07.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The goal of the proposed study is to directly and rigorously address current scientific controversy about phonological awareness intervention content and timing for prekindergarten and kindergarten children. Using an experimental design, we will compare the relative impact of phonological sensitivity + phonemic awareness intervention versus phonemic awareness intervention on children's phonemic awareness and later reading and spelling abilities. We expect that both types of intervention will lead to impacts beyond business-as-usual instruction but do not have directional hypotheses as to which type of intervention will be most effective. Also, we will determine the relative efficacy of intervening in prekindergarten versus kindergarten, examine child characteristics that might moderate effects, and explore whether a transition point can be identified as to when phonemic awareness intervention may be most effective. Ultimately, our findings will help optimize early phonological awareness instruction.

Eligibility Criteria

Inclusion Criteria: * Parent consent * Child assent * Enrollment in prekindergarten or kindergarten * At least 4 years old * Score below the 50th percentile on the Phonological Awareness Component Score of the Comprehensive Test of Phonological Processing 2 (CTOPP 2). Exclusion Criteria: * Severe sensory impairment that interferes with the capacity to hear instructions or see visual stimuli as reported by parents on the initial Child/Family Survey. * Inability to speak or understand English at a basic level, as indicated by a criterion score \< 6 on the Clinical Evaluation of Language Fundamentals Preschool-3 Screening Test (CELF:PS). * Severe behavior issues as indicated by (a) a score 3 on the aggressive behavior item of the externalizing subscale of the Student Risk Screening Scale-Early Childhood (SRSS-EC) or (b) a total score ≥ 16 on the externalizing subscale of the SRSS-EC.

Contact & Investigator

Central Contact

Shayne B Piasta, PhD

✉ piasta.1@osu.edu

📞 614-688-4454

Principal Investigator

Shayne B Piasta, PhD

PRINCIPAL INVESTIGATOR

Ohio State University

Frequently Asked Questions

Who can join the NCT07017010 clinical trial?

This trial is open to participants of all sexes, aged 4 Years or older, up to 9 Years, studying Reading Difficulties. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07017010 currently recruiting?

Yes, NCT07017010 is actively recruiting participants. Contact the research team at piasta.1@osu.edu for enrollment information.

Where is the NCT07017010 trial being conducted?

This trial is being conducted at Tallahassee, United States, Columbus, United States.

Who is sponsoring the NCT07017010 clinical trial?

NCT07017010 is sponsored by Ohio State University. The principal investigator is Shayne B Piasta, PhD at Ohio State University. The trial plans to enroll 720 participants.

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