Developmental Language DisorderEA-SHELLSNCT07103044
Early Achievements - Shaping Early Language and Literacy Skills
A study testing Early Achievements - Shaping Early Language and Literacy Skills in people with Developmental Language Disorder, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 monthsHealthy volunteers can take part
- Conditions the study is for
- Developmental Language Disorder
- What is being tested?
- Early Achievements - Shaping Early Language and Literacy Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2021to 31 Oct 2026
- 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 45 to 65 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 12Show fewer
- 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
- Inclusionary criteria for students in the TD group:
- 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)
Who cannot join
- Exclusionary criteria for both the DLD group and TD group:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shaylee Woods, MS contact
United States1 site, 1 recruiting
- Recruiting
Kennedy Krieger Institute
Baltimore, Maryland, 21211
Rebecca Landa, PhD, 443-923-7584, landa@kennedykrieger.org
Ebony Holliday, PhD, 4439237724, hollidaye@kennedykrieger.org
About this study
Official title: Developing Early Achievements for Pre-K Children With Developmental Language Disorders: A Comprehensive Contextualized Embodied Approach
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.
Read the detailed description
The primary goal of this research study is to determine whether Early Achievements - Shaping Early Language and Literacy Skills (EA-SHELLS) training improves teachers' implementation of the EA-SHELLS instructional approach in their inclusive prekindergarten (pre-K) classrooms. A secondary purpose of this research study is to determine the effects the EA-SHELLS instructional approach on pre-K children's (with and without language disorders/delays) language-related emergent literacy skills (vocabulary, syntax, narrative representation, and listening comprehension). The investigators hypothesize that teachers who participate in the EA-SHELLS professional development program will show greater use of evidence-based instructional strategies (the EA-SHELLS approach) and greater self-efficacy relating to language-related literacy instruction compared to teachers who do not receive the training. Additionally, the investigators predict that students taught by teachers receiving the training will perform better on testing measures when compared to their peers who do not receive supported classroom instruction.
An iterative development process was utilized for this study. Phase 1 (initial development and implementation) and Phase 2 (iterative development and implementation of the intervention) took place prior to this clinicaltrials.gov submission. A total of 17 teachers and 87 students completed the full research program in these phases. Preliminary results show significant positive outcomes on student and teacher measures.
In Phase 3 (randomized control trial), investigators will further test the above hypotheses by collecting data from teacher and student participants at pre-treatment, midpoint, and post-treatment time points in comparison to teachers and students who do not receive the training. The duration of the study will last approximately 14 weeks. Teachers may be randomly assigned to receive either the full training or no training until after post-treatment data are collected. Teachers in the EA-SHELLS trained group will attend the 6-hour virtual EA-SHELLS workshop and participate in approximately 14 in-person coaching sessions. During this EA-SHELLS training period, data will be collected on teacher and student participants in both arms of the trial.
- Conditions
- Developmental Language Disorder
- Being tested
- Early Achievements - Shaping Early Language and Literacy Skills
- Keywords
- Literacy, Reading, Language, Education
- Medical subject headings
- Language Development Disorders, Literacy, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Achievements - Shaping Early Language and Literacy SkillsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (served as a participant characterization measure).
Secondary outcomes (13)
Clinical Evaluation of Language Fundamentals - Preschool, 3rd Edition (CELF-P3)
This measure serves as an indicator of overall language ability at pre- and post-treatment time points. Additionally, this test helps differentiate between TD and DLD students. Students will be administered the following subtests: Sentence Comprehension, Word Structure, Expressive Vocabulary, and Basic Concepts. This measure was used in iterative development phases and will be used in the RCT.
Measured: Baseline and post 14-week training period
Teacher Book and Book-Related Activity Fidelity
Video recordings are collected and coded (masked to group and timepoint) to evaluate teachers' implementation fidelity of book and book-related activities in their classrooms. Videos will be collected pre- and post-treatment as well as approximately 1-3 times during the training period (intra-intervention). These measures were used in iterative development phases and will be used in the RCT.
Measured: Baseline and post 14-week training period as well as 1-3 times during the training period
Teacher Satisfaction and Feasibility Survey
This survey provides insights about EA-SHELLS features that inspire willingness to use and those that present implementation barriers and/or facilitators (related to feasibility). A subset of items addresses perceptions of the feasibility and satisfaction of EA-SHELLS, as will open-ended questions about how to improve each component of EA-SHELLS to engage and enrich learning for their students. Data collected from iterative development phases was used to inform revisions to maximize practicality of adopting the intervention. This measure will continue to be used in the RCT to measure satisfaction with, and perceptions of, the feasibility of EA-SHELLS.
Measured: Post 14-week training period.
The Barriers Checklist
This survey was adapted from Bartholomew et al. (2007) and consists of 10 items pertaining to resources (e.g., insufficient time, resource, training) and procedural barriers (e.g., complexity, compatibility) that threaten usability and feasibility. This measure was used in iterative development phases to inform revisions to the intervention. We will continue to use this measure in the RCT to provide information regarding teacher perceived barriers to implementation of EA-SHELLS.
Measured: Post 14-week training period.
The Teacher Consumer Review Form
This survey is a 5-point Likert-type scale to rate EA-SHELLS components (scope and sequence, instructional contexts, instructional strategies, materials, and PD) regarding: (1) relative advantage over currently available (or previously experienced) oral language interventions (including cost); (2) compatibility with available resources and organizational structures, work demands, and instructional practices already used; and (3) complexity of the content, activities, and structure of the intervention. For each dimension, teachers are asked to describe two ways to improve the program to increase its relative advantage and overall compatibility, and to reduce complexity. This measure was used in iterative development phases and will be used in the RCT.
Measured: Post 14-week training period.
The Self-Efficacy Scale
This survey is completed by teachers at pre- and post-treatment to document their confidence in delivering the EA-SHELLS intervention. Results will have implications for the usability and feasibility of EA-SHELLS and perceived complexity. During the iterative development phase, this scale was given to all teacher participants. Responses influenced revisions to the intervention. For the RCT, this scale will only be given to teachers in the Full Training group.
Measured: Post 14-week training period.
Teacher Self-Rating of Coaching Impact
This researcher developed survey provides information about the social validity, feasibility, and practicality of the coaching process and content obtained. This measure was used in iterative development phases and will be used in the RCT.
Measured: Post 14-week training period
Adapted Texas Christian University Workshop Evaluation Form
Researchers adapted the Texas Christian University Workshop Evaluation Form (Institute of Behavioral Research, 2002) to address a DLD and TD populations included in this study. This survey consists of 22 items each rated on a 5-point Likert-type scale. Data collected measure teachers' reactions to workshop content and intentions to implement EA-SHELLS components. This measure was used in iterative development phases and will be used in the RCT.
Measured: Baseline, after the initial workshop training.
Demographic Forms
Demographic information is collected for both student and teacher participants. Data is collected via an online survey. Teachers provide additional information regarding education and teaching experience. Surveys focused on children include specific questions regarding development and any diagnosed developmental delays. These measures were used in iterative development phases and will be used in the RCT.
Measured: Baseline
EA-SHELLS Home Survey
The EA-SHELLS Home Survey is a researcher created measure relating to participants' exposure to books and early literacy/communication enhancing strategies at home. The Home Survey consists of 15 multiple choice and Likert scale items. This measure was used in iterative development phases and will be used in the RCT.
Measured: Baseline
Teacher Rating of Oral Language and Literacy (TROLL), adapted
Teacher participants complete an adapted version of the TROLL (Dickinson et al., 2003) for each consented student. This teacher completed survey provides information pertaining to students' language and literacy skills as observed by their teacher in their daily classroom routines. This measure was used in iterative development phases and will be used in the RCT.
Measured: Baseline
Focus Group Feedback
Focus group meetings last approximately 1 hour and use a set of IRB approved interview questions. Teacher responses are transcribed and qualitatively analyzed. This measure was used in iterative development phases and will be used in the RCT. In iterative development phases, all teacher participants attended pre- and post-training focus group meetings. In the RCT, only teacher participants in the Full Training Group will attend pre- and post-treatment focus group meetings.
Measured: Baseline and post 14-week training period
Unit Review Forms
Teachers complete the researcher-created forms at the end of each intervention unit. Teachers report the frequency with which they use instructional strategies as well as their perceived strengths and challenges when instructing their students. This measure was used in iterative development phases and will be used in the RCT.
Measured: Every 2-4 weeks throughout the training period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start26 Aug 2021
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Language DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Education Sciences
- Responsible party
- Sponsor
- Investigators
- Rebecca Landa, PhD, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103044
- Sponsor's protocol ID
- IRB00294058
- Other IDs
- R324A210031
- Acronym
- EA-SHELLS
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Early Achievements for Pre-K Children With Developmental Language Disorders: A Comprehensive Contextualized Embodied Approach
- ClinicalTrials.gov ID
- NCT07103044
- Acronym / sponsor ID
- EA-SHELLS / IRB00294058
- Conditions
- Developmental Language Disorder
- Keywords
- Literacy, Reading, Language, Education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- Institute of Education Sciences
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 5 Aug 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.
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.
Detailed description
The primary goal of this research study is to determine whether Early Achievements - Shaping Early Language and Literacy Skills (EA-SHELLS) training improves teachers' implementation of the EA-SHELLS instructional approach in their inclusive prekindergarten (pre-K) classrooms. A secondary purpose of this research study is to determine the effects the EA-SHELLS instructional approach on pre-K children's (with and without language disorders/delays) language-related emergent literacy skills (vocabulary, syntax, narrative representation, and listening comprehension). The investigators hypothesize that teachers who participate in the EA-SHELLS professional development program will show greater use of evidence-based instructional strategies (the EA-SHELLS approach) and greater self-efficacy relating to language-related literacy instruction compared to teachers who do not receive the training. Additionally, the investigators predict that students taught by teachers receiving the training will perform better on testing measures when compared to their peers who do not receive supported classroom instruction.
An iterative development process was utilized for this study. Phase 1 (initial development and implementation) and Phase 2 (iterative development and implementation of the intervention) took place prior to this clinicaltrials.gov submission. A total of 17 teachers and 87 students completed the full research program in these phases. Preliminary results show significant positive outcomes on student and teacher measures.
In Phase 3 (randomized control trial), investigators will further test the above hypotheses by collecting data from teacher and student participants at pre-treatment, midpoint, and post-treatment time points in comparison to teachers and students who do not receive the training. The duration of the study will last approximately 14 weeks. Teachers may be randomly assigned to receive either the full training or no training until after post-treatment data are collected. Teachers in the EA-SHELLS trained group will attend the 6-hour virtual EA-SHELLS workshop and participate in approximately 14 in-person coaching sessions. During this EA-SHELLS training period, data will be collected on teacher and student participants in both arms of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Full Training Group | Experimental | Behavioral: Early Achievements - Shaping Early Language and Literacy SkillsTeachers 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. |
| 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. |
Who may qualify
- Ages
- 45 to 65 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Early Achievements - Shaping Early Language and Literacy SkillsEA-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. | Behavioural | Experimental: Full Training Group |
Primary outcome
Assessment of Story Comprehension (ASC)
Time frame: Baseline and post 14-week training period
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
Narrative Language Measure - Listening (NLM)
Time frame: Baseline
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
Vocabulary Assessment
Time frame: Baseline and post 14-week training period as well as every 2-4 weeks during the training period.
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.
The Narrative Assessment Protocol-Second Edition (NAP-2)
Time frame: Baseline and post 16-week training period
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.
Expressive Vocabulary Test, Third Edition (EVT-3; Williams, 2019)
Time frame: Baseline (served as a participant characterization measure).
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.
13 secondary outcomes
Clinical Evaluation of Language Fundamentals - Preschool, 3rd Edition (CELF-P3)
Time frame: Baseline and post 14-week training period
Teacher Book and Book-Related Activity Fidelity
Time frame: Baseline and post 14-week training period as well as 1-3 times during the training period
Teacher Satisfaction and Feasibility Survey
Time frame: Post 14-week training period.
The Barriers Checklist
Time frame: Post 14-week training period.
The Teacher Consumer Review Form
Time frame: Post 14-week training period.
The Self-Efficacy Scale
Time frame: Post 14-week training period.
Teacher Self-Rating of Coaching Impact
Time frame: Post 14-week training period
Adapted Texas Christian University Workshop Evaluation Form
Time frame: Baseline, after the initial workshop training.
Demographic Forms
Time frame: Baseline
EA-SHELLS Home Survey
Time frame: Baseline
Teacher Rating of Oral Language and Literacy (TROLL), adapted
Time frame: Baseline
Focus Group Feedback
Time frame: Baseline and post 14-week training period
Unit Review Forms
Time frame: Every 2-4 weeks throughout the training period
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 5 Aug 2025.
- This page provides an overview of the EA-SHELLS study for interested teachers to learn more about participation.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Shaylee Woods, MS contact
Rebecca Landa, PhD principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Achievements - Shaping Early Language and Literacy Skills in people with Developmental Language Disorder, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site 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 12 inclusion and 5 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 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Rebecca Landa, PhD (443-923-7591, landa@kennedykrieger.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Story Comprehension (ASC) (time frame: Baseline and post 14-week training period). The study lists 5 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 5 Aug 2025.