Recruiting

Phonological Interventions

Sponsor:

Ohio State University

Code:

NCT07017010

Conditions

Reading Difficulties

Eligibility Criteria

Sex: All

Age: 4 - 9

Healthy Volunteers: Not accepted

Interventions

phonemic awareness intervention (PA)

phonological sensitivity + phonemic awareness intervention (PSPA)

delayed onset phonemic awareness intervention (DPA)

Study Details

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.

Conditions

Reading Difficulties

Study ID

NCT07017010

Start date

Sep 12, 2025

Status verified date

Aug, 2025

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 9

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

720 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: phonemic awareness intervention (PA)

In the PA condition, children will receive 12 weeks of intervention, approximately 15 minutes per day, for 4 or 5 days per week, for a maximum of 48 lessons.

experimental: phonological sensitivity + phonemic awareness intervention (PSPA)

In the PSPA condition, children will receive 12 weeks of intervention in 15- minute lessons, with a maximum of 48 lessons, 4 or 5 days per week.

experimental: delayed onset phonemic awareness intervention (DPA)

In the DPA condition, children will receive intervention that includes identical types of lessons to the PA condition but with a delayed onset to match the start of week 7 for other conditions. The difference will be that they receive instruction for only 6 weeks, or for a total of 24 maximum lessons. These also will be delivered for approximately 15 minutes each day, for 4 or 5 days per week.

no intervention: Instruction-as-usual control (BAU)

In the BAU condition children will receive only their typical general education classroom instruction as provided by their classroom teacher. This will vary naturally from classroom to classroom.

Interventions

phonemic awareness intervention (PA)

All 12 weeks of lessons will exclusively focus on instruction at the phoneme level (i.e., the individual sounds in words), with activities addressing the blending of sounds to form short words. Other activities may include counting the number of sounds heard in a word, matching letter tiles to the sounds heard in the word, and separating short words into their component sounds.

phonological sensitivity + phonemic awareness intervention (PSPA)

The first six weeks of intervention will include a focus on being able to manipulate (separate and blend) parts of words larger than the individual sounds. This will include manipulating compound word components, syllables, and initial sounds and rhyming components of words. Activities may include matching pictures of words, assembling/disassembling puzzle pieces that represent words, and sorting pictures (words) by their first or ending sounds. The second six weeks of intervention will focus on phonemic awareness, as described for the PA intervention condition, and be the same as what the children in the DPA intervention condition experience.

delayed onset phonemic awareness intervention (DPA)

The six weeks of intervention will focus on phonemic awareness, as described for the PA intervention condition, and be the same as the second six weeks of lessons that the children in the PSPA intervention condition experience.

Primary outcome measure

  • Test of Preschool Early Literacy: PA subtest [ Time Frame: 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) ]
  • Comprehensive Test of Phonological Processing 2: Elision, Blending Words, and Sound Matching subtests [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Shayne B Piasta, PhD

614-688-4454piasta.1@osu.edu

Caitlin Florek

614-247-9944florek.16@osu.edu

Locations

Florida State University

Recruiting

Tallahassee, Florida, United States, 32310

Contacts

Karli Willis

850-645-1172kborowski@fcrr.org

Principal Investigator:

Beth M Phillips, PhD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Caitlin Florek

614-247-9944florek.16@osu.edu

Principal Investigator:

Shayne B Piasta, PhD

More Information

Sponsor

Ohio State University

Last update posted

Dec 8, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-12-08.