Clinical trial NCT07017010: Optimizing Phonological Awareness Learning in Prekindergarten and Kindergarten to Improve Later Reading and Spelling
Official title: Optimizing Phonological Awareness Learning in Prekindergarten and Kindergarten to Improve Later Reading and Spelling
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Reading Difficulties
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Florida State University
First posted: 2025-06-12
Enrollment: 720
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Primary outcomes:
measure: Test of Preschool Early Literacy: PA subtest
timeFrame: screening/pretest (within first 3 months of school year prior to intervention), midtest (within 2 months following the first 6 weeks of intervention and before starting the second 6 weeks of intervention), posttest (within 3 months of intervention end)
measure: Comprehensive Test of Phonological Processing 2: Elision, Blending Words, and Sound Matching subtests
timeFrame: screening/pretest (within first 3 mos, prior to intervention), midtest (within 2 mos after first 6 weeks of intervention, posttest (within 3 mos of intervention end), followup 1 (~15-18 mos after enrollment), followup 2 (PK only, ~27-30 mos after enroll)
Secondary outcomes:
measure: Woodcock-Johnson Tests of Achievement IV: Letter Word ID, Word Attack, and Spelling subtests
timeFrame: posttest (within 3 months of intervention end), followup 1 (~15-18 mos after enrollment), followup 2 (PK only, ~27-30 mos after enroll)
measure: Test of Word Reading Efficiency 2
timeFrame: posttest (within 3 months of intervention end), followup 1 (~15-18 mos after enrollment), followup 2 (PK only, ~27-30 mos after enroll)
measure: Word Spelling assessment
timeFrame: posttest (within 3 months of intervention end), followup 1 (~15-18 mos after enrollment), followup 2 (PK only, ~27-30 mos after enroll)
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Shayne B Piasta, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida State University
name: Beth M Phillips, PhD
role: PRINCIPAL_INVESTIGATOR
References: