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CompletedNCT03878641Updated Nov 6, 2020

Literacy and Language Interventions Via Telepractice for School-Age Children

An interventional study of Children in Grade 1 to 5 with literacy and language needs in Literacy-language Intervention, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2020-11-06.

Sponsored by Vanderbilt University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
6 Years to 11 Years
Sex
All
01

Study summary

Telepractice refers to the application of telecommunication technology (e.g., Skype, Webex, Zoom) to the delivery of speech-language and audiology services. The development of telepractice, an emerging alternative to traditional service delivery, has been driven by the need for equitable access and cost-effective services to all client, regardless of geographical locations, physical conditions, or social and economic status (Theodoros, 2011).

The purpose of this study is to examine the feasibility of telepractice-delivered intervention targeting literacy (i.e., reading and writing) and literate language skills (e.g., narrative skills) to promote better academic outcomes in school-age children. The investigators conduct a single-subject, multiple probe design across four participants to examine the functional relation between a telepractice intervention and two educational outcomes - reading self-corrections and narrative ability. Participants with language and literacy needs receive three weekly intervention sessions via ZOOM (a videoconferencing software). A single-subject, multiple-probe design across participants enables the examination of treatment effectiveness: If three replications of treatment effect are established across participants (i.e., visual analysis indicates evident behavioral change on progress-monitoring assessment), the proposed intervention yields a high likelihood of producing benefits to children who share similar learning needs.

In addition to intervention effectiveness of telepractice, the investigators examine feasibility along two dimensions: Fidelity and scoring reliability. Fidelity here includes two components - fidelity of intervention (i.e., whether the intervention activities are implemented as intended) and procedural fidelity of probe assessment administration (whether the progress-monitoring probes are administered as intended). Scoring reliability (e.g., interobserver agreement) examines if the interventionist's scoring is consistent with a reliability coder's scoring. Evidence derived from analyses of fidelity, reliability, and intervention effectiveness will be examined collectively to determine the feasibility of delivering literacy and language intervention via telepractice.

Read the detailed description

The single-subject multiple-probe design comprises four phases: (a) eligibility determination, (b) a baseline condition, wherein participants receive business-as-usual practice, (c) a 15-week intervention condition, and (d) a maintenance condition (see Figure 1).

Eligibility determination. The investigators employ a two-stage screening procedure (psycho-educational assessments) to identify children in Grade 1 to 5 who demonstrate language-based learning difficulties. Following the completion of the two-stage screening, the investigators conduct a mock tutoring session to familiarize the potential participants with the technology platform. The interventionist fills out a behavior checklist that consists of steps needed to be accomplished in the mock session to determine if the child meets the minimum criteria for telepractice candidacy.

Baseline condition. In the baseline condition, the interventionist meets with each participant three times a week to collect baseline data. Participants receive business-as-usual instruction-that is, the interventionist stops the child immediately at point of miscues, supplies the word, and tells the child to continue reading.

Intervention condition. The proposed intervention program consists of three components: (a) Word reading and phonics instruction, (b) applying a comprehension monitoring strategy to improve text reading accuracy, and (c) complex sentences use in written text. With each participant, instruction is delivered in three 50-minute weekly sessions across 15 weeks. Intervention activities delivered in the first, second, and third session of the week is outlined in Figure 1. The interventionist collects the CUBED Narrative Language Measure (NLM) probe on the fourth day of the week when no instruction is given. The 3-minute reading probes will be administered on a weekly basis.

Maintenance condition. Across three weeks of no intervention, each of the progress-monitoring assessments is administered once per week.

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Conditions studied

  • Literacy-language Intervention
03

In context

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Children who produce substantial number of reading miscues and/or self-correct more less 25% of their miscues, and/or who present weaknesses in expressive language skills with a total CUBED score lower than grade-specific cut scores.

Exclusion criteria

Exclusion Criteria:

  • Additional exclusionary criteria include: (a) nonverbal IQ standard score > 80 and (b) no reported history of autism, hearing loss, visual impairment, or other neurological disorder (c) meet the criteria for telepratice candidacy (as informed by a behavior checklist filled out by the examiner).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Children in Grade 1 to 5 with literacy and language needs

    The investigators intend to identify children in Grade 1 to 5 who demonstrate language-based learning difficulties. Using the two-stage screening, the investigators will identify children who produce substantial number of reading miscues and/or self-correct more less 25% of their miscues, and/or who present weaknesses in expressive language skills with a total CUBED score lower than grade-specific cut scores.

    Behavioral: Children in Grade 1 to 5 with literacy and language needs

Interventions

  • BehavioralChildren in Grade 1 to 5 with literacy and language needs

    The investigators deliver a telepractice-based intervention targeting: (a) Word reading and phonics instruction, (b) applying a comprehension monitoring strategy to improve text reading accuracy, and (c) complex sentences use in written text. Participants receive 3 online 50-minute tutoring session weekly across 15 weeks.

06

What researchers measure

Primary outcomes

  1. Reading Comprehension

    The Passage Comprehension subtest of the Woodcock Reading Mastery Test-3rd edition (WRMT-III) and the Reading Comprehension test of the Wechsler Individual Achievement Test-3rd edition (WIAT-III) will be administered to assess a child's reading comprehension

    Time frame: Baseline to 4 months

Secondary outcomes

  1. Complex sentence use in narrative production

    The investigators count the instances of dependent clauses and T-units (operationalized as an independent clause plus its dependent clause\[s\]). We divide the number of dependent clause tokens by the number of T-units to form the index of complex sentence proportion.

    Time frame: Weekly for 4 months

  2. Reading self-correction in independent oral reading

    The Curriculum-Based Measurement Passage Reading Fluency probe is administered twice weekly to monitor a child's progress in self-correction proportion. The primary dependent variable, self-correction proportion, is operationalized as the number of self-corrections divided by the number of reading miscues produced in a 3-minute reading probe.

    Time frame: Weekly to 4 months

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Study locations

1 site
  • Vanderbilt University
    Nashville, Tennessee 37203, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03878641
Lead sponsor
Vanderbilt University
Responsible party
Shih-Yuan Liang (Principal Investigator, Vanderbilt University) — Principal investigator
First posted
Mar 18, 2019
Start date
Apr 29, 2019
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Nov 6, 2020

Study contacts

Melanie Schuele, PhD
study chair · Vanderbilt University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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