Speech DisordersNCT02490826

Table to Tablet (T2T): A Novel Intervention Framework for Children With Speech Sound Disorders

A study testing Table-based T2T intervention and Tablet-based T2T intervention in people with Speech Disorders, run by Aveiro University at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 42 to 78 months
Conditions the study is for: Speech Disorders
What is being tested?: Table-based T2T intervention and Tablet-based T2T intervention
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 sitePortugal
Study dates: Oct 2014to 1 Oct 2017
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 42 to 78 months
All sexes
No healthy volunteers
Child

Who may be able to join

Diagnose of Phonologically based Speech and Sound Disorder;
Portuguese as native language;
Audition of 20 decibels (dB) or lower in the frequencies 500, 1000, 2000 and 4000;
Normal non-verbal ability (NVIQ) according to age;
Receptive language skills within normal limits.

Who cannot join

Diagnose of childhood apraxia of speech;
Structural or functional oral alterations

Trial locations and contacts

1 site in 1 country.

Portugal1 site

Aveiro's University
Aveiro, 3810

Other trials in Portugal

About this study

Official title: Intervention Software for Children With Speech Sound Disorders

The primary aim of this study is to develop software as a tool in speech and language therapy for the treatment of children (Portuguese and English) with phonologically based Speech Sound Disorders (SSD). Further, this project aims to test the effectiveness of this approach with two groups of preschool and school aged children with phonologically based SSD, with one group consisting of European Portuguese (EP) speakers and one group of British English (BE) speakers. Performance across the two groups will be compared. The total duration of the project will be 30 month.

Read the detailed description

The Table to Tablet (T2T) project aims to develop software as a tool in speech and language therapy for the treatment of children (Portuguese and English) with phonologically based Speech Sound Disorders (SSD). Further, this project aims to test the effectiveness of this approach with two groups of children aged between 3 years and 6 months and 6 years and 6 months with phonologically based Speech Sound Disorders (SSD).

One group consists of European Portuguese (EP) speakers and one group of British English (BE) speakers. Each group should include 20 children with the referred criteria and the performance across the two groups will be compared.

The total duration of the project will be 30 month (software development over the first 12 months and an intervention study during following 18 months).

The T2T team includes 3 Speech and Language Therapists and 3 engineers/researchers plus a designer that will develop the T2T material.

Conditions: Speech Disorders
Being tested: Table-based T2T intervention, Tablet-based T2T intervention
Keywords: Speech Sound Disorders, Tabletop, Digital
Medical subject headings: Speech Disorders, Speech Sound Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Table-based T2T interventionOther
Phonological therapy consists of a combination of phonological awareness activities, auditory and discrimination and auditory bombardment activities. This activities will be based on table top materials. The items used in the intervention will be based on the child's target speech production goals. This intervention will include the following areas:
- Auditory Bombardment;
- Auditory and discrimination;
- Letter-sound knowledge;
- Phoneme identity and phoneme matching;
- Blending;
- Segmentation;
- Rhyme;
- Phoneme manipulation.
Tablet-based T2T interventionOther
Phonological therapy consists of a combination of phonological awareness activities, auditory and discrimination and auditory bombardment activities. This activities will be based on digital materials presented on a tablet. The items used in the intervention will be based on the child's target speech production goals. This intervention will include the following areas:
- Auditory Bombardment;
- Auditory and discrimination;
- Letter-sound knowledge;
- Phoneme identity and phoneme matching;
- Blending;
- Segmentation;
- Rhyme;
- Phoneme manipulation.

Study groups in NCT02490826
Study group	Role	What they receive
Table-based T2T intervention	Active comparator	A combined phonological awareness therapy, listening and discrimination and auditory bombardment activities intervention will be applied. This will be based in a table top material version. The intervention will consist of 12 weekly sessions (individual) of 45 min in duration, divided into two blocks (6+6) without any breaks. Receives: Other: Table-based T2T intervention
Tablet-based T2T intervention	Active comparator	A combined phonological awareness therapy, listening and discrimination and auditory bombardment activities intervention will be applied. This will be based in a tablet (digital) material version. The intervention will consist of 12 weekly sessions (individual) of 45 min in duration, divided into two blocks (6+6) without any breaks. Receives: Other: Tablet-based T2T intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Consonants Correct
Calculation of the percentage of the correct produced consonants
Measured: one year

Secondary outcomes (7)

Parental Reports
Questionnaire focused on: speech improvement; enjoyment of therapy; effect of therapy on their understanding of their child.
Measured: one and a half year
Intelligibility Score
How well a client's speech is understood by other individuals, i.e. understandability of speech.
Measured: one year
Percentage of occurence of phonological processes
Calculations of the percentage of occurence of phonological processes
Measured: one year
Generalisation Score
Generalization probe of the trained phonological process to five non-intervention words.
Measured: one year
Phonetic Inventory
List of produces consonants
Measured: one year
Percentage of Correct Vowels
Calculation of the percentage of the correct produced vowels
Measured: one year
Percentage of Phonemes Correct
Calculation of the percentage of the correct produced phonemes
Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 20141 Oct 2017

First posted7 Jul 2015 (estimated)
Study startOct 2014
Primary completion1 Oct 2017
Study completion1 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Speech DisordersStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02490826
Sponsor's protocol ID: PGIS73
Status last verified: Aug 2019
First submitted: 22 Jun 2015
Last updated: 28 Aug 2019
Results posted: No
Data monitoring committee: No

Publications

Lousada M, Jesus LM, Capelas S, Margaca C, Simoes D, Valente A, Hall A, Joffe VL. Phonological and articulation treatment approaches in Portuguese children with speech and language impairments: a randomized controlled intervention study. Int J Lang Commun Disord. 2013 Mar-Apr;48(2):172-87. doi: 10.1111/j.1460-6984.2012.00191.x. Epub 2012 Dec 4.
PubMed 23472957
Lousada M, Jesus LM, Hall A, Joffe V. Intelligibility as a clinical outcome measure following intervention with children with phonologically based speech-sound disorders. Int J Lang Commun Disord. 2014 Sep-Oct;49(5):584-601. doi: 10.1111/1460-6984.12095. Epub 2014 May 26.
PubMed 24861159
Jesus LM, Santos J, Martinez J. The Table to Tablet (T2T) Speech and Language Therapy Software Development Roadmap. JMIR Res Protoc. 2019 Jan 30;8(1):e11596. doi: 10.2196/11596.
PubMed 30698534

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Feasibility and Preliminary Effects of a Therapeutic Approach Using Ultrasound Visual Biofeedback in Children With AFI: a Pilot Randomized Clinical Trial.
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Using Non-invasive Brain Stimulation to Explore Potential Treatments to Reduce Speech Errors in Adults Who Stutter
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All Speech Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intervention Software for Children With Speech Sound Disorders
ClinicalTrials.gov ID: NCT02490826
Acronym / sponsor ID: PGIS73
Conditions: Speech Disorders
Keywords: Speech Sound Disorders, Tabletop, Digital
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Aveiro UniversityUniversity, hospital or other
Study start: Oct 2014
Primary completion: 1 Oct 2017 (actual)
Study completion: 1 Oct 2017 (actual)
First posted: 7 Jul 2015 (estimated)
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.

Detailed description

The total duration of the project will be 30 month (software development over the first 12 months and an intervention study during following 18 months).

The T2T team includes 3 Speech and Language Therapists and 3 engineers/researchers plus a designer that will develop the T2T material.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Table-based T2T intervention	Active comparator	Other: Table-based T2T interventionA combined phonological awareness therapy, listening and discrimination and auditory bombardment activities intervention will be applied. This will be based in a table top material version. The intervention will consist of 12 weekly sessions (individual) of 45 min in duration, divided into two blocks (6+6) without any breaks.
Tablet-based T2T intervention	Active comparator	Other: Tablet-based T2T interventionA combined phonological awareness therapy, listening and discrimination and auditory bombardment activities intervention will be applied. This will be based in a tablet (digital) material version. The intervention will consist of 12 weekly sessions (individual) of 45 min in duration, divided into two blocks (6+6) without any breaks.

Who may qualify

Ages: 42 to 78 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Diagnose of Phonologically based Speech and Sound Disorder;
Portuguese as native language;
Audition of 20 decibels (dB) or lower in the frequencies 500, 1000, 2000 and 4000;
Normal non-verbal ability (NVIQ) according to age;
Receptive language skills within normal limits.

Key exclusion criteria (2 listed)

Diagnose of childhood apraxia of speech;
Structural or functional oral alterations

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
Table-based T2T interventionPhonological therapy consists of a combination of phonological awareness activities, auditory and discrimination and auditory bombardment activities. This activities will be based on table top materials. The items used in the intervention will be based on the child's target speech production goals. This intervention will include the following areas: * Auditory Bombardment; * Auditory and discrimination; * Letter-sound knowledge; * Phoneme identity and phoneme matching; * Blending; * Segmentation; * Rhyme; * Phoneme manipulation.	Other	Table-based T2T intervention
Tablet-based T2T interventionPhonological therapy consists of a combination of phonological awareness activities, auditory and discrimination and auditory bombardment activities. This activities will be based on digital materials presented on a tablet. The items used in the intervention will be based on the child's target speech production goals. This intervention will include the following areas: * Auditory Bombardment; * Auditory and discrimination; * Letter-sound knowledge; * Phoneme identity and phoneme matching; * Blending; * Segmentation; * Rhyme; * Phoneme manipulation.	Other	Tablet-based T2T intervention

Primary outcome

Percentage of Consonants Correct
Time frame: one year
Calculation of the percentage of the correct produced consonants

7 secondary outcomes

Parental Reports
Time frame: one and a half year
Intelligibility Score
Time frame: one year
Percentage of occurence of phonological processes
Time frame: one year
Generalisation Score
Time frame: one year
Phonetic Inventory
Time frame: one year
Percentage of Correct Vowels
Time frame: one year
Percentage of Phonemes Correct
Time frame: one year

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 28 Aug 2019.
Background: PubMed 23472957Lousada M, Jesus LM, Capelas S, Margaca C, Simoes D, Valente A, Hall A, Joffe VL. Phonological and articulation treatment approaches in Portuguese children with speech and language impairments: a randomized controlled intervention study. Int J Lang Commun Disord. 2013 Mar-Apr;48(2):172-87. doi: 10.1111/j.1460-6984.2012.00191.x. Epub 2012 Dec 4.
Background: PubMed 24861159Lousada M, Jesus LM, Hall A, Joffe V. Intelligibility as a clinical outcome measure following intervention with children with phonologically based speech-sound disorders. Int J Lang Commun Disord. 2014 Sep-Oct;49(5):584-601. doi: 10.1111/1460-6984.12095. Epub 2014 May 26.
Derived from this study: PubMed 30698534Jesus LM, Santos J, Martinez J. The Table to Tablet (T2T) Speech and Language Therapy Software Development Roadmap. JMIR Res Protoc. 2019 Jan 30;8(1):e11596. doi: 10.2196/11596.
Official T2T websiteLink provided by the sponsor.

Related trials for Speech Disorders

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Feasibility and Preliminary Effects of a Therapeutic Approach Using Ultrasound Visual Biofeedback in Children With AFI: a Pilot Randomized Clinical Trial.
Childhood Apraxia of Speech, Speech Sound Disorders
Recruiting
Using Non-invasive Brain Stimulation to Explore Potential Treatments to Reduce Speech Errors in Adults Who Stutter
Stuttering, Fluency Disorder
Recruiting
STIMPulseControl Ancillary Speech Study
Parkinson Disease, Impulse Control Disorder
Recruiting
Network Connectivity and Temporal Processing in Adolescents Who Stutter
Stuttering, Childhood, Stuttering

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.

Luís MT Jesus principal investigator

Aveiro's 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 Table-based T2T intervention and Tablet-based T2T intervention in people with Speech Disorders, run by Aveiro University at 1 site in Portugal.

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 5 inclusion and 2 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 28 Aug 2019. 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 Portugal. 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?

Percentage of Consonants Correct (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02490826, which also lists 3 linked publications.

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 28 Aug 2019; AzTrials last refreshed its copy on 29 Oct 2026.