Literacy-language InterventionNCT03878641
Literacy and Language Interventions Via Telepractice for School-Age Children
A study testing Children in Grade 1 to 5 with literacy and language needs in people with Literacy-language Intervention, run by Vanderbilt University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Literacy-language Intervention
- What is being tested?
- Children in Grade 1 to 5 with literacy and language needs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Literacy-language Intervention
- Being tested
- Children in Grade 1 to 5 with literacy and language needs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Children in Grade 1 to 5 with literacy and language needsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Children in Grade 1 to 5 with literacy and language needs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 4 months
Secondary outcomes (2)
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.
Measured: Weekly for 4 months
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.
Measured: Weekly to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start29 Apr 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Literacy-language InterventionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shih-Yuan Liang, Vanderbilt University
- Investigators
- Melanie Schuele, PhD, Study chair, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878641
- Sponsor's protocol ID
- Telepractice
- Status last verified
- Nov 2020
- First submitted
- 15 Mar 2019
- Last updated
- 6 Nov 2020
- 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 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Literacy and Language Interventions Via Telepractice for School-Age Children
- ClinicalTrials.gov ID
- NCT03878641
- Acronym / sponsor ID
- Telepractice
- Conditions
- Literacy-language Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 Mar 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children in Grade 1 to 5 with literacy and language needs | Experimental | Behavioral: Children in Grade 1 to 5 with literacy and language needsThe 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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
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 |
|---|---|---|
| Children in Grade 1 to 5 with literacy and language needsThe 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. | Behavioural | Children in Grade 1 to 5 with literacy and language needs |
Primary outcome
Reading Comprehension
Time frame: Baseline to 4 months
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
2 secondary outcomes
Complex sentence use in narrative production
Time frame: Weekly for 4 months
Reading self-correction in independent oral reading
Time frame: Weekly to 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Literacy-language Intervention
Active, not recruiting
Promoting Caregiver Implementation of an Effective Early Learning Intervention
Developmental Language Disorder, Reading; Difficult
Recruiting
Haptics in Virtual Reality
Literacy, Literacy-language Intervention
Enrolling by invitationPhase 2
Long-Term Outcomes of Early Communication Intervention for Deaf/Hard of Hearing Toddlers
Hearing Loss, Bilateral
Not yet recruiting
eHealth Literacy Intervention for Spanish Speaking Older Adults in the US
eHealth Literacy
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. This study is not recruiting at the moment.
Melanie Schuele, PhD study chair
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Children in Grade 1 to 5 with literacy and language needs in people with Literacy-language Intervention, run by Vanderbilt University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading Comprehension (time frame: Baseline to 4 months). 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 6 Nov 2020.