Reading DifficultiesProject OPALNCT07017010
Optimizing Phonological Awareness Learning in Prekindergarten and Kindergarten to Improve Later Reading and Spelling
A study testing phonemic awareness intervention (PA), phonological sensitivity + phonemic awareness intervention (PSPA) and delayed onset phonemic awareness intervention (DPA) in people with Reading Difficulties, run by Ohio State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Reading Difficulties
- What is being tested?
- phonemic awareness intervention (PA), phonological sensitivity + phonemic awareness intervention (PSPA) and delayed onset phonemic awareness intervention (DPA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Sep 2025to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Caitlin Florek, 614-247-9944, florek.16@osu.edu
Shayne B Piasta, PhD
- Recruiting
Florida State University
Tallahassee, Florida, 32310
Karli Willis, 850-645-1172, kborowski@fcrr.org
Beth M Phillips, PhD
About this study
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
- Being tested
- phonemic awareness intervention (PA), phonological sensitivity + phonemic awareness intervention (PSPA), delayed onset phonemic awareness intervention (DPA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phonemic awareness intervention (PA)Behavioural
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)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| phonemic awareness intervention (PA) | Experimental | 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. Receives: Behavioral: phonemic awareness intervention (PA) |
| phonological sensitivity + phonemic awareness intervention (PSPA) | Experimental | 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. Receives: Behavioral: phonological sensitivity + phonemic awareness intervention (PSPA) |
| delayed onset phonemic awareness intervention (DPA) | Experimental | 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. Receives: Behavioral: delayed onset phonemic awareness intervention (DPA) |
| Instruction-as-usual control (BAU) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Preschool Early Literacy: PA subtest
The TOPEL phonological awareness subtest includes 27 items with a focus on blending and deleting various sound components within words (e.g., compound word components, syllables, individual sounds). Some items do, and others do not include pictorial supports where children can respond by pointing to their answer.
Measured: 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
The CTOPP2 includes three core subtests that we will administer. Elision is a 34- item subtest to assess how participants can say a word then say what is left after leaving out designated sounds. Blending Words is a 33-item subtest to see how a participant would combine sounds by listening to a series of audio recorded separate sounds then putting together the sounds to make a full word. Sound matching is a 26-item subtest to see how a participant can match sounds. The examiner says a target word then says three other words while pointing to drawings showing the words. For the first 13 items, participants have to point to pictures that match the first sound in the target word and for the following 13 items they match the end sound.
Measured: 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 (3)
Woodcock-Johnson Tests of Achievement IV: Letter Word ID, Word Attack, and Spelling subtests
We will administer three subtests of the widely used standardized measure the Woodcock-Johnson Tests of Achievement IV (WJ Letter Word ID, WJ Word Attack, and WJ Spelling). Letter Word ID requires children to correctly label individual letters and then individual words of increasing difficulty (maximum 75, with stopping rules after successive errors). Word Attack requires children to correctly pronounce nonwords of increasing length and difficulty (maximum 32, with stopping rules after successive errors). Spelling requires children to write the conventional spelling of words dictated to them by a recording (maximum 30, with stopping rules after successive errors).
Measured: 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
The Test of Word Reading Efficiency 2 is a standardized and widely used measure of reading fluency. In both subtests children are given 45 seconds in which to read as many of a list of presented words as possible. In list one, the words are real words. In list two the words are pronounceable nonsense words. Both lists become increasingly difficult.
Measured: 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
The Word Spelling assessment includes two parts: asking children to spell 5 dictated real words and 5 dictated nonsense words, with each part scored separately.
Measured: posttest (within 3 months of intervention end), followup 1 (~15-18 mos after enrollment), followup 2 (PK only, ~27-30 mos after enroll)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start12 Sep 2025
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reading DifficultiesStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Florida State University
- Responsible party
- Principal investigator, Shayne B. Piasta, Ohio State University
- Investigators
- Shayne B Piasta, PhD, Principal investigator, Ohio State UniversityBeth M Phillips, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017010
- Sponsor's protocol ID
- OSUSTUDY20250377
- Other IDs
- R01HD112429
- Acronym
- Project OPAL
- Status last verified
- Aug 2025
- First submitted
- 2 Jun 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will generate (a) longitudinal data concerning children's phonological awareness, reading and spelling, and other early literacy skills; (b) data concerning children's speech/language skills, working memory, and problem behavior at screening/pretest; and (c) descriptive data concerning child demographics, participating centers/schools, and intervention implementation/fidelity. We will share child behavioral data (raw scores plus normative scores when available), child demographic data (with age at first assessment rather than birthdate), center/school descriptive data, and summative scores for intervention implementation/fidelity data. We will make deidentified study data publicly available via LDbase. We will also use the Open Science Framework for sharing project protocols and analytic code, along with preregistrations for specific analyses related to main (or supplemental) aims.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Phonological Awareness Learning in Prekindergarten and Kindergarten to Improve Later Reading and Spelling
- ClinicalTrials.gov ID
- NCT07017010
- Acronym / sponsor ID
- Project OPAL / OSUSTUDY20250377
- Conditions
- Reading Difficulties
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Florida State University
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| phonemic awareness intervention (PA) | Experimental | Behavioral: 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. |
| phonological sensitivity + phonemic awareness intervention (PSPA) | Experimental | Behavioral: 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. |
| delayed onset phonemic awareness intervention (DPA) | Experimental | Behavioral: 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. |
| Instruction-as-usual control (BAU) | No intervention | –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. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | phonemic awareness intervention (PA) |
| 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. | Behavioural | phonological sensitivity + phonemic awareness intervention (PSPA) |
| 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. | Behavioural | delayed onset phonemic awareness intervention (DPA) |
Primary outcome
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)
The TOPEL phonological awareness subtest includes 27 items with a focus on blending and deleting various sound components within words (e.g., compound word components, syllables, individual sounds). Some items do, and others do not include pictorial supports where children can respond by pointing to their answer.
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)
The CTOPP2 includes three core subtests that we will administer. Elision is a 34- item subtest to assess how participants can say a word then say what is left after leaving out designated sounds. Blending Words is a 33-item subtest to see how a participant would combine sounds by listening to a series of audio recorded separate sounds then putting together the sounds to make a full word. Sound matching is a 26-item subtest to see how a participant can match sounds. The examiner says a target word then says three other words while pointing to drawings showing the words. For the first 13 items, participants have to point to pictures that match the first sound in the target word and for the following 13 items they match the end sound.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Project websiteLink provided by the sponsor.
- Project Open Science Framework siteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The study will generate (a) longitudinal data concerning children's phonological awareness, reading and spelling, and other early literacy skills; (b) data concerning children's speech/language skills, working memory, and problem behavior at screening/pretest; and (c) descriptive data concerning child demographics, participating centers/schools, and intervention implementation/fidelity. We will share child behavioral data (raw scores plus normative scores when available), child demographic data (with age at first assessment rather than birthdate), center/school descriptive data, and summative scores for intervention implementation/fidelity data. We will make deidentified study data publicly available via LDbase. We will also use the Open Science Framework for sharing project protocols and analytic code, along with preregistrations for specific analyses related to main (or supplemental) aims.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shayne B Piasta, PhD principal investigator
Ohio State University
Beth M Phillips, PhD principal investigator
Florida State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phonemic awareness intervention (PA), phonological sensitivity + phonemic awareness intervention (PSPA) and delayed onset phonemic awareness intervention (DPA) in people with Reading Difficulties, run by Ohio State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shayne B Piasta, PhD (614-688-4454, piasta.1@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.