NCT07103044

Brief Summary

Language skills are important for long-term reading comprehension success. Yet there are limited instructional approaches available for prekindergarten (pre-K) teachers to use in their inclusive classrooms to boost literacy-related language skills in children with and without language delays or disorders. In the first part of this study, the investigators will develop a teacher training program focused on building pre-K children's language-based literacy skills. Teachers will be trained and will use the strategies that they learn during literacy-related activities in their inclusive pre-K classrooms. Their students' language-related literacy skills will be measured before and after their training. Based on teacher feedback and child assessment information, the training program will be revised. In the final part of the study, a preliminary randomized control trial (RCT) will be done using the revised training approach. The results of the RCT will help the investigators know if the teacher training program helps to improve the effectiveness of teachers' instruction and their students' development of language-related literacy skills. The primary goal of this research study is to determine whether study-trained pre-K teachers in inclusive early childhood education classrooms use more effective teaching strategies than teachers who do not receive the training. A secondary goal of this research study is to determine if this teacher training program strengthens language-related literacy skills for students with and without language disorders or delays. The research team hypothesizes that teachers who participate in the training program will use effective teaching strategies more often than teachers who do not receive the training. Additionally, the investigators predict that teachers who receive the training will feel more confident teaching early language-based literacy skills to their students (with and without language delays/disorders) than teachers who do not receive the training. Researchers also predict that students taught by teachers who receive the training will perform better on language tests when compared to their peers in classrooms where the teacher training program was not used.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Aug 2021Oct 2026

Study Start

First participant enrolled

August 26, 2021

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

5.1 years

First QC Date

July 10, 2025

Last Update Submit

July 28, 2025

Conditions

Keywords

LiteracyReadingLanguageEducation

Outcome Measures

Primary Outcomes (5)

  • Assessment of Story Comprehension (ASC)

    This measure serves as an indicator of narrative comprehension at pre- and post-treatment time points. Students will be administered two parallel versions of this assessment at both testing points. The combined raw score will be used for comparison. This measure was used in iterative development phases and will be used in the RCT

    Baseline and post 14-week training period

  • Narrative Language Measure - Listening (NLM)

    This measure serves as an indicator of narrative comprehension at pre- and post-treatment time points. Students will be administered two parallel versions of this assessment at both testing points. The combined raw score will be used for comparison. This measure was used in iterative development phases and will be used in the RC

    Baseline

  • Vocabulary Assessment

    This researcher created measure assesses vocabulary learning throughout the study. Students will participate in testing at pre- and post-treatment time points. Additionally, students will participate in monthly intra-intervention testing. Raw scores will be used for data analyses. This measure was used in iterative development phases. It was revised across phases. The most updated version will be used in the RCT.

    Baseline and post 14-week training period as well as every 2-4 weeks during the training period.

  • The Narrative Assessment Protocol-Second Edition (NAP-2)

    This measure was used in early iterative phases to measure syntax and narrative production, without transcription. Two stories were used (equated on length and difficulty) each at pre-, mid-point and post-treatment (constant across children and phases), with one story given at all three times to control for confounding effects of different stories administered per the authors' recommendation.

    Baseline and post 16-week training period

  • Expressive Vocabulary Test, Third Edition (EVT-3; Williams, 2019)

    This student assessment was used in early iterative phases of this research. It was used as a direct assessment of generalized expressive vocabulary performance. This measure will not be used in the RCT.

    Baseline (served as a participant characterization measure).

Secondary Outcomes (13)

  • Clinical Evaluation of Language Fundamentals - Preschool, 3rd Edition (CELF-P3)

    Baseline and post 14-week training period

  • Teacher Book and Book-Related Activity Fidelity

    Baseline and post 14-week training period as well as 1-3 times during the training period

  • Teacher Satisfaction and Feasibility Survey

    Post 14-week training period.

  • The Barriers Checklist

    Post 14-week training period.

  • The Teacher Consumer Review Form

    Post 14-week training period.

  • +8 more secondary outcomes

Study Arms (2)

Experimental: Full Training Group

EXPERIMENTAL

Teachers assigned to the Full Training group will participate in a collaborative coaching approach, Practice-Based Coaching (Snyder et al., 2015). Coaches will support teachers in targeting meaning-related (language-based) emergent literacy skills during whole and small group interactions with their students. The duration of the coaching period is approximately 14 weeks with about one coaching session per week. Teachers will be coached to implement Early Achievements-Shaping Early Language and Literacy Skills (EA-SHELLS) strategies during book reading and book-related activities. See more details about the instructional approach below in the intervention description.

Behavioral: Early Achievements - Shaping Early Language and Literacy Skills

No Intervention: Quick Training Group

NO INTERVENTION

Teachers assigned to the Quick Training group will not receive any training or intervention while data are being collected from both groups. Teachers in this group will conduct their classroom instruction as originally planned while the teachers in the Full Training group receive the EA-SHELLS training. After the completion of data collection, teachers will be invited to participate in a collaborative coaching approach, Practice-Based Coaching (Snyder et al., 2015). Coaches will support teachers in targeting meaning-related emergent literacy skills during whole and small group interactions with their students for 2 coaching sessions. Teachers will be coached to implement EA-SHELLS strategies during book reading and book-related activities. Teacher data will be collected during the quick training period but will be analyzed separately from RCT data used to examine efficacy of EA-SHELLS.

Interventions

EA-SHELLS is a professional development program that includes a 6-hour workshop and about 14 in-person coaching sessions using Practice-Based Coaching. Teachers will implement the EA-SHELLS instructional approach in their classrooms during whole-group book sharing activities to target vocabulary, syntax, story grammar, and listening comprehension. Teachers will also lead story retelling activities using pictures cards and 3D props to further target all four skills. Teachers will be provided with commercially available children's books augmented with supplemental text to explicitly define vocabulary and cue teachers' elicitation of children's verbal engagement for targeted vocabulary, syntactically elaborated sentences, and story grammar elements. Instructional strategies include naturalistic developmental behavioral intervention and language facilitating (e.g., focused stimulation) strategies. Teachers will read each provided book about four times over one to two weeks.

Experimental: Full Training Group

Eligibility Criteria

Age45 Months - 65 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Having students in the identified age range
  • Having at least one child in their classroom who receives language-focused related services, has an existing diagnosis of language delay or disorder, or meets study criteria for DLD on the research measures
  • Planning to teach for the duration of the training period.
  • use phrases containing a noun and a verb in most spontaneous utterances (per teacher report)
  • are exposed to English \>50% of their time at home (per parent report). receive language-focused related services, have a prior diagnosis of language delay or disorder, or meet study criteria for language delay on the CELF P-3 and/or CUBED NLM.
  • CELF P-3: score more than 1 standard deviation below the mean on at least one subtest
  • NLM criteria: receives two Listening Retell score raw score of \<5 on Fall measures or \<7 on Winter measures
  • between approximately 45-65 months of age
  • cannot have an identified DLD or developmental disability and does not meet above criteria for language delay/disorder
  • between approximately 45-65 months of age.
  • are exposed to English \>50% of their time at home (per parent report)

You may not qualify if:

  • having a visual or hearing impairment after correction (per parent report)
  • having a motor impairment that renders them unable to reach and grasp objects or sit independently
  • score more than1.5 standard deviation below the mean on the Mullen Scales of Early Learning Visual Reception subscale
  • This criterion will be evaluated on a case-by-case basis at the PI's discretion as children's performance may be affected by any of a number of factors and a single response variation may result in a child missing the cut-off while clearly succeeding cognitively in the classroom.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Language Development DisordersLiteracyLanguage

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCommunicationBehavior

Study Officials

  • Rebecca Landa, PhD

    Hugo W. Moser Research Institute at Kennedy Krieger Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Landa, PhD

CONTACT

Shaylee Woods, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Upon confirmation of eligibility and completion of the baseline assessments, teachers will be randomly assigned to the Full Training group or the Quick Training group. Randomization will be done at the classroom level as teachers will implement the instructional approach with their whole class rather than specific students.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2025

First Posted

August 5, 2025

Study Start

August 26, 2021

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

August 5, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations