Clinical trial NCT03878641: Literacy and Language Interventions Via Telepractice for School-Age Children
Official title: Literacy and Language Interventions Via Telepractice for School-Age Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Literacy-language Intervention
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 4
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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:

* 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).

Primary outcomes:
measure: Reading Comprehension
timeFrame: Baseline to 4 months
Secondary outcomes:
measure: Complex sentence use in narrative production
timeFrame: Weekly for 4 months
measure: Reading self-correction in independent oral reading
timeFrame: Weekly to 4 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Melanie Schuele, PhD
role: STUDY_CHAIR
References: