- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00945113
Pilot: Group Therapy for Children Who Stammer
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tyne and Wear
-
Newcastle-upon-Tyne, Tyne and Wear, United Kingdom
- Newcastle-upon-Tyne Hospitals NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
attendance at one-week speech therapy group
|
One-week cross-district speech therapy group for older children (aged 8 to 15) who stammer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
July 2009 week 2, July 2009 week 4, October 2009 week 4
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lucy E Paterson, MA, BSc, Newcastle upon Tyne NHS Hospitals Foundation Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4565
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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