StammeringNCT00945113
Pilot: Group Therapy for Children Who Stammer
A study testing One-week speech therapy group in people with Stammering, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The aim of the study is to answer the question: Is a large-scale research study of the effectiveness of group speech and language therapy (SALT) for young people who stammer possible? The study will look at the issues involved in setting up a large-scale investigation of treatment for young people who stammer. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Stammering
- What is being tested?
- One-week speech therapy group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2009to Oct 2009
- 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 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 8;0 years and 15;11 years at 20.07.09
- Currently in treatment, on review or on waiting list for treatment.
- Has had an initial NHS Speech and Language Therapy assessment by Newcastle, Northumberland or North Tyneside Speech and Language Therapy service.
- Has a diagnosis of stammering.
- Has sufficient understanding of spoken (English) language to score at or above the 16th percentile on the Understanding Linguistic Concepts subtest of the CELF-4UK assessment.
- Available to attend treatment for the whole week of 20th July 2009
- Available to attend treatment for the whole week of 24th August 2009
Who cannot join
- Diagnosis of Attention and/or Hyperactivity Disorders
- Diagnosis of moderate or severe general learning difficulties
- Diagnosis of moderate or severe receptive and/or pragmatic language difficulties
- Parent/carer for whom an interpreter would be required
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Newcastle-upon-Tyne Hospitals NHS Trust
Newcastle upon Tyne, Tyne and Wear
About this study
Official title: A Pilot Randomised Controlled Trial of the Effectiveness of Intensive Group Speech and Language Therapy as a Treatment for Older Children Who Stammer
The aim of the study is to answer the question: Is a large-scale research study of the effectiveness of group speech and language therapy (SALT) for young people who stammer possible?
The study will look at the issues involved in setting up a large-scale investigation of treatment for young people who stammer. It will inform the investigators whether larger studies would be possible and give some early-stage information on the effectiveness of group SALT for these young people. The findings will pave the way for building and testing out treatment programmes where there will be clear positive benefit for young people who stammer and their families.
Read more
To answer the research question, the study will tell the investigators (a) how easy/difficult it was to get people to take part, (b) young people and parents'/carers' views on taking part and (c) whether the assessments were able to pick up changes in speech and attitudes towards stammering reported by the young people and their carers.
Sufficient numbers of participants were not recruited to carry out the intended rehearsal pilot RCT study design.
- Conditions
- Stammering
- Being tested
- One-week speech therapy group
- Keywords
- pilot, stammer, stutter, children, randomised controlled trial, RCT, Speech and Language Therapy, Stuttering
- Medical subject headings
- Stuttering, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-week speech therapy groupBehavioural
One-week cross-district speech therapy group for older children (aged 8 to 15) who stammer
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | attendance at one-week speech therapy group Receives: Behavioral: One-week speech therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Assessment of the Speaker's Evaluation of Stuttering (OASES) score
Measured: July 2009 week 2, July 2009 week 4, October 2009 week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StammeringStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Newcastle Upon-Tyne, North Tyneside Primary Care Trust, Northumberland Care Trust
- Responsible party
- Sponsor
- Investigators
- Lucy E Paterson, MA, BSc, Principal investigator, Newcastle upon Tyne NHS Hospitals Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945113
- Sponsor's protocol ID
- 4565
- Status last verified
- Oct 2015
- First submitted
- 21 Jul 2009
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomised Controlled Trial of the Effectiveness of Intensive Group Speech and Language Therapy as a Treatment for Older Children Who Stammer
- ClinicalTrials.gov ID
- NCT00945113
- Acronym / sponsor ID
- 4565
- Conditions
- Stammering
- Keywords
- pilot, stammer, stutter, children, randomised controlled trial, RCT, Speech and Language Therapy, Stuttering
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Newcastle Upon-Tyne, North Tyneside Primary Care Trust, Northumberland Care Trust
- Study start
- Jun 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 23 Jul 2009 (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.
The aim of the study is to answer the question: Is a large-scale research study of the effectiveness of group speech and language therapy (SALT) for young people who stammer possible?
The study will look at the issues involved in setting up a large-scale investigation of treatment for young people who stammer. It will inform the investigators whether larger studies would be possible and give some early-stage information on the effectiveness of group SALT for these young people. The findings will pave the way for building and testing out treatment programmes where there will be clear positive benefit for young people who stammer and their families.
To answer the research question, the study will tell the investigators (a) how easy/difficult it was to get people to take part, (b) young people and parents'/carers' views on taking part and (c) whether the assessments were able to pick up changes in speech and attitudes towards stammering reported by the young people and their carers.
Sufficient numbers of participants were not recruited to carry out the intended rehearsal pilot RCT study design.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: One-week speech therapy groupattendance at one-week speech therapy group |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Aged between 8;0 years and 15;11 years at 20.07.09
- Currently in treatment, on review or on waiting list for treatment.
- Has had an initial NHS Speech and Language Therapy assessment by Newcastle, Northumberland or North Tyneside Speech and Language Therapy service.
- Has a diagnosis of stammering.
- Has sufficient understanding of spoken (English) language to score at or above the 16th percentile on the Understanding Linguistic Concepts subtest of the CELF-4UK assessment.
Key exclusion criteria (4 listed)
- Diagnosis of Attention and/or Hyperactivity Disorders
- Diagnosis of moderate or severe general learning difficulties
- Diagnosis of moderate or severe receptive and/or pragmatic language difficulties
- Parent/carer for whom an interpreter would be required
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 |
|---|---|---|
| One-week speech therapy groupOne-week cross-district speech therapy group for older children (aged 8 to 15) who stammer | Behavioural | Treatment group |
Primary outcome
Overall Assessment of the Speaker's Evaluation of Stuttering (OASES) score
Time frame: July 2009 week 2, July 2009 week 4, October 2009 week 4
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 12 Oct 2015.
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.
Lucy E Paterson, MA, BSc principal investigator
Newcastle upon Tyne NHS Hospitals Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-week speech therapy group in people with Stammering, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
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 7 inclusion and 4 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 12 Oct 2015. 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 Kingdom. 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?
Overall Assessment of the Speaker's Evaluation of Stuttering (OASES) score (time frame: July 2009 week 2, July 2009 week 4, October 2009 week 4). 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 12 Oct 2015; AzTrials last refreshed its copy on 4 Nov 2026.