NCT03878641

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 29, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

March 15, 2019

Last Update Submit

November 5, 2020

Conditions

Outcome Measures

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

    Baseline to 4 months

Secondary Outcomes (2)

  • Complex sentence use in narrative production

    Weekly for 4 months

  • Reading self-correction in independent oral reading

    Weekly to 4 months

Study Arms (1)

Children in Grade 1 to 5 with literacy and language needs

EXPERIMENTAL

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

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.

Children in Grade 1 to 5 with literacy and language needs

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

Study Officials

  • Melanie Schuele, PhD

    Vanderbilt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 18, 2019

Study Start

April 29, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations