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Recruiting NCT07017010

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

No phase Interventional Reading Difficulties

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: phonemic awareness intervention (PA), phonological sensitivity + phonemic awareness intervention (PSPA), delayed onset phonemic awareness intervention (DPA).
Who it may be relevant to
Registry conditions: Reading Difficulties. Basic parameters: 4 years — 9 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral 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.
  • Behavioral 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
  • Behavioral 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 measures

  • 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)]
Secondary outcome measures (3)
  • Woodcock-Johnson Tests of Achievement IV: Letter Word ID, Word Attack, and Spelling subtests [Time frame: posttest (within 3 months of intervention end), followup 1 (~15-18 mos after enrollment), followup 2 (PK only, ~27-30 mos after enroll)]
  • Test of Word Reading Efficiency 2 [Time frame: posttest (within 3 months of intervention end), followup 1 (~15-18 mos after enrollment), followup 2 (PK only, ~27-30 mos after enroll)]
  • Word Spelling assessment [Time frame: posttest (within 3 months of intervention end), followup 1 (~15-18 mos after enrollment), followup 2 (PK only, ~27-30 mos after enroll)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 2 centers
  • Florida State University — Tallahassee
  • The Ohio State University — Columbus

Identifiers

NCT: NCT07017010 · OSUSTUDY20250377 · R01HD112429

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗