Speech TherapyNCT05900180
Pediatric Speech Therapy Session Frequency and Speech Outcomes
A study testing Speech Therapy in people with Speech Therapy and Language Disorders in Children, run by Connecticut Children's Medical Center at 1 site in United States.
Trial summary
Examination of frequency of therapy and effect on clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 months to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Speech Therapy, Language Disorders in Children, Articulation Disorders in Children
- What is being tested?
- Speech Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 30 Oct 2023
- 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 18 months to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Medical order for speech therapy
- Patients eligible for speech therapy at Connecticut Children's (qualify for receptive, expressive language and/or articulation therapy)
- Diagnosis of communication disorder.ICD-10 codes will be utilized pertaining to expressive, receptive language and articulation disorders (ICD-10 code specific to patient: F80.0, F80.1, F80.2, F80.4, F80.9, R47.89, R41.841)
- Patient recommended for individual (i.e. not group) treatment
- 18 months to 16 years of age
- Completed 1 plan of care (POC) with a duration of 8 sessions
- Attended at least 80% of scheduled visits during their plan of care period (still completing 8 sessions of therapy, may have extended time to completion).
- Services for a full 8-session plan of care.
Who cannot join
- - Seeking speech therapy care for treatment of disorders related to diagnosis of voice, feeding, fluency, and/or cognition
- Patient unable to complete standardized tests (EOWPVT-4, ROWPVT-4, GFTA-3, REEL-4)
- Patients in group speech therapy
- Patients younger than 18 months or older than 16 years of age
- Not willing to complete a full POC (8 sessions)
- Unable/unwilling to attend 80% of scheduled visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
About this study
Examination of frequency of therapy and effect on clinical outcomes.
Read the detailed description
The goal of this clinical trial is to compare speech therapy outcomes in children ages 18 months to 16 years who participate in weekly speech therapy with home programming versus every-other week speech therapy with home programming in outpatient speech therapy. The main question it aims to answer is: Does a change in how often speech therapy sessions are delivered show an increased benefit in language and articulation standardized test scores? Participants will be randomly assigned to either (1) weekly or (2) every-other-week speech therapy for a total of 8 sessions. Researchers will compare these two groups to see if there are differences in speech outcomes.
- Conditions
- Speech Therapy, Language Disorders in Children, Articulation Disorders in Children, Communication Disorder, Childhood, Pediatric, Mode of Therapy
- Being tested
- Speech Therapy
- Medical subject headings
- Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech TherapyBehavioural
Delivery of speech therapy services
| Study group | Role | What they receive |
|---|---|---|
| Every-other-week therapy with home programming | Active comparator | Receipt of standard speech therapy care (every-other-week) for 8.0 sessions Receives: Behavioral: Speech Therapy |
| Weekly therapy with home programming | Experimental | Receipt of speech therapy care (every week) for 8.0 sessions Receives: Behavioral: Speech Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Articulation and intelligibility
Scores on the following standardized measures: Goldman Fristoe Test of Articulation- Third Edition (GFTA-3) ; Average Standard Score range is from 86-114; an increase in standard score indicates improvement in intelligibility.
Measured: Baseline, immediately after treatment (up to 4 months)
Change in Receptive vocabulary skills
Scores on the following standardized measure: Receptive One Word Picture Vocabulary Test- Fourth Edition (ROVPVT-4); Average Standard Score range is from 85-115; an increase in standard score indicates improvement in understanding vocabulary.
Measured: Baseline, immediately after treatment (up to 4 months)
Change in Expressive vocabulary skills
Scores on the following standardized measure: Expressive One Word Picture Vocabulary Test- Fourth Edition (EOWPVT-4); Average Standard Score range is from 85-115; an increase in standard score indicates improvement in understanding or labeling vocabulary.
Measured: Baseline, immediately after treatment (up to 4 months)
Change in Receptive and expressive early language skills
Scores on the following standardized measures: Receptive-Expressive Emergent Language Scale- Fourth Edition (REEL-4); Average Standard Score range is from 90-109; an increase in standard score indicates improvement in language ability score.
Measured: Baseline, immediately after treatment (up to 4 months)
Secondary outcomes (1)
Home Exercise Plan (HEP) provision
Parent-reported compliance with home therapy programming
Measured: up 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 posted12 Jun 2023
- Study start1 Jan 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Speech TherapyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginia Van Epps, M.Ed., Principal investigator, Connecticut Children's Medical CenterMary Dortenzio, MS, Study director, Connecticut Children's Medical CenterJodi Urzua, MS, Study director, Connecticut Children's Medical CenterEmma Mendillo, MA, Study director, Connecticut Children's Medical CenterMorgan Daur-Schierholz, MS, Study director, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900180
- Sponsor's protocol ID
- 22-160
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van Epps VM, Daur-Schierholz M, Dortenzio M, Mendillo E, Urzua J, Brimacombe M, Hinderer KA. How changes to frequency of treatment and mode of treatment improved paediatric speech-language pathology services: A pragmatic clinical trial. Int J Speech Lang Pathol. 2026 Mar 8:1-12. doi: 10.1080/17549507.2026.2630835. Online ahead of print.
PubMed 41795638
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Speech Therapy Session Frequency and Speech Outcomes
- ClinicalTrials.gov ID
- NCT05900180
- Acronym / sponsor ID
- 22-160
- Conditions
- Speech Therapy, Language Disorders in Children, Articulation Disorders in Children, Communication Disorder, Childhood, Pediatric, Mode of Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 12 Jun 2023 (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.
Examination of frequency of therapy and effect on clinical outcomes.
Detailed description
The goal of this clinical trial is to compare speech therapy outcomes in children ages 18 months to 16 years who participate in weekly speech therapy with home programming versus every-other week speech therapy with home programming in outpatient speech therapy. The main question it aims to answer is: Does a change in how often speech therapy sessions are delivered show an increased benefit in language and articulation standardized test scores? Participants will be randomly assigned to either (1) weekly or (2) every-other-week speech therapy for a total of 8 sessions. Researchers will compare these two groups to see if there are differences in speech outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Every-other-week therapy with home programming | Active comparator | Behavioral: Speech TherapyReceipt of standard speech therapy care (every-other-week) for 8.0 sessions |
| Weekly therapy with home programming | Experimental | Behavioral: Speech TherapyReceipt of speech therapy care (every week) for 8.0 sessions |
Who may qualify
- Ages
- 18 months to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Medical order for speech therapy
- Patients eligible for speech therapy at Connecticut Children's (qualify for receptive, expressive language and/or articulation therapy)
- Diagnosis of communication disorder.ICD-10 codes will be utilized pertaining to expressive, receptive language and articulation disorders (ICD-10 code specific to patient: F80.0, F80.1, F80.2, F80.4, F80.9, R47.89, R41.841)
- Patient recommended for individual (i.e. not group) treatment
- 18 months to 16 years of age
Key exclusion criteria (6 listed)
- - Seeking speech therapy care for treatment of disorders related to diagnosis of voice, feeding, fluency, and/or cognition
- Patient unable to complete standardized tests (EOWPVT-4, ROWPVT-4, GFTA-3, REEL-4)
- Patients in group speech therapy
- Patients younger than 18 months or older than 16 years of age
- Not willing to complete a full POC (8 sessions)
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 |
|---|---|---|
| Speech TherapyDelivery of speech therapy services | Behavioural | Every-other-week therapy with home programming, Weekly therapy with home programming |
Primary outcome
Change in Articulation and intelligibility
Time frame: Baseline, immediately after treatment (up to 4 months)
Scores on the following standardized measures: Goldman Fristoe Test of Articulation- Third Edition (GFTA-3) ; Average Standard Score range is from 86-114; an increase in standard score indicates improvement in intelligibility.
Change in Receptive vocabulary skills
Time frame: Baseline, immediately after treatment (up to 4 months)
Scores on the following standardized measure: Receptive One Word Picture Vocabulary Test- Fourth Edition (ROVPVT-4); Average Standard Score range is from 85-115; an increase in standard score indicates improvement in understanding vocabulary.
Change in Expressive vocabulary skills
Time frame: Baseline, immediately after treatment (up to 4 months)
Scores on the following standardized measure: Expressive One Word Picture Vocabulary Test- Fourth Edition (EOWPVT-4); Average Standard Score range is from 85-115; an increase in standard score indicates improvement in understanding or labeling vocabulary.
Change in Receptive and expressive early language skills
Time frame: Baseline, immediately after treatment (up to 4 months)
Scores on the following standardized measures: Receptive-Expressive Emergent Language Scale- Fourth Edition (REEL-4); Average Standard Score range is from 90-109; an increase in standard score indicates improvement in language ability score.
1 secondary outcome
Home Exercise Plan (HEP) provision
Time frame: up 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 4 May 2026.
- Results publication: PubMed 41795638Van Epps VM, Daur-Schierholz M, Dortenzio M, Mendillo E, Urzua J, Brimacombe M, Hinderer KA. How changes to frequency of treatment and mode of treatment improved paediatric speech-language pathology services: A pragmatic clinical trial. Int J Speech Lang Pathol. 2026 Mar 8:1-12. doi: 10.1080/17549507.2026.2630835. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Virginia Van Epps, M.Ed. principal investigator
Connecticut Children's Medical Center
Mary Dortenzio, MS study director
Connecticut Children's Medical Center
Jodi Urzua, MS study director
Connecticut Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech Therapy in people with Speech Therapy and Language Disorders in Children, run by Connecticut Children's Medical Center 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 8 inclusion and 6 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 4 May 2026. 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?
Change in Articulation and intelligibility (time frame: Baseline, immediately after treatment (up to 4 months)). The study lists 4 primary outcomes in all. 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 NCT05900180, which also lists 1 linked publication.
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 4 May 2026.