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Clinical Trials/NCT07103044
NCT07103044RecruitingNot Applicable

Developing Early Achievements for Pre-K Children With Developmental Language Disorders: A Comprehensive Contextualized Embodied Approach

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.1 site in 1 country360 target enrollmentStarted: August 26, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
360
Locations
1
Primary Endpoint
Narrative Language Measure - Listening (NLM)

Study Overview

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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
45 Months to 65 Months (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •for Teachers
  • •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.
  • •Inclusion Criteria for Students in the DLD group:
  • •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
  • •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)

Exclusion Criteria

  • •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.

Arms & Interventions

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.

Intervention: Early Achievements - Shaping Early Language and Literacy Skills (Behavioral)

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.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

  • Clinical Evaluation of Language Fundamentals - Preschool, 3rd Edition (CELF-P3)(Baseline and post 14-week training period)
  • The Self-Efficacy Scale(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)
  • The Barriers Checklist(Post 14-week training period.)
  • Demographic Forms(Baseline)
  • Teacher Satisfaction and Feasibility Survey(Post 14-week training period.)
  • EA-SHELLS Home Survey(Baseline)
  • Teacher Rating of Oral Language and Literacy (TROLL), adapted(Baseline)
  • The Teacher Consumer Review Form(Post 14-week training period.)
  • Teacher Self-Rating of Coaching Impact(Post 14-week training period)
  • Adapted Texas Christian University Workshop Evaluation Form(Baseline, after the initial workshop training.)
  • Focus Group Feedback(Baseline and post 14-week training period)
  • Unit Review Forms(Every 2-4 weeks throughout the training period)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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