Pilot: Group Therapy for Children Who Stammer

Stammering Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00945113
• Other study ID #: 4565
• Status: Completed
• Phase: N/A
• First received: July 21, 2009
• Last updated: October 7, 2015
• Start date: June 2009
• Est. completion date: October 2009

Study information

• Verified date: October 2015
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics CommitteeUnited Kingdom: Newcastle University
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 15 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Stammering

Intervention

Behavioral:
• One-week speech therapy group
One-week cross-district speech therapy group for older children (aged 8 to 15) who stammer

Locations

Country	Name	City	State
United Kingdom	Newcastle-upon-Tyne Hospitals NHS Trust	Newcastle-upon-Tyne	Tyne and Wear

Sponsors (4)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust	North Tyneside Primary Care Trust, Northumberland Care Trust, University of Newcastle Upon-Tyne

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Assessment of the Speaker's Evaluation of Stuttering (OASES) score		July 2009 week 2, July 2009 week 4, October 2009 week 4	No