NCT02490826

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

June 22, 2015

Last Update Submit

August 22, 2019

Conditions

Keywords

Speech Sound DisordersTabletopDigital

Outcome Measures

Primary Outcomes (1)

  • Percentage of Consonants Correct

    Calculation of the percentage of the correct produced consonants

    one year

Secondary Outcomes (7)

  • Parental Reports

    one and a half year

  • Intelligibility Score

    one year

  • Percentage of occurence of phonological processes

    one year

  • Generalisation Score

    one year

  • Phonetic Inventory

    one year

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Other: Tablet-based T2T intervention

Interventions

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.

Table-based T2T intervention

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.

Tablet-based T2T intervention

Eligibility Criteria

Age42 Months - 78 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aveiro's University

Aveiro, 3810, Portugal

Location

Related Publications (3)

  • 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.

    PMID: 23472957BACKGROUND
  • 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.

    PMID: 24861159BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Speech DisordersSpeech Sound Disorder

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Luís MT Jesus

    Aveiro's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 22, 2015

First Posted

July 7, 2015

Study Start

October 1, 2014

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations