NCT00945113

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2009

Shorter than P25 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

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

4 months

First QC Date

July 21, 2009

Last Update Submit

October 7, 2015

Conditions

Keywords

pilotstammerstutterchildrenrandomised controlled trialRCTSpeech and Language TherapyStuttering

Outcome Measures

Primary Outcomes (1)

  • Overall Assessment of the Speaker's Evaluation of Stuttering (OASES) score

    July 2009 week 2, July 2009 week 4, October 2009 week 4

Study Arms (1)

Treatment group

EXPERIMENTAL

attendance at one-week speech therapy group

Behavioral: One-week speech therapy group

Interventions

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

Treatment group

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Newcastle-upon-Tyne Hospitals NHS Trust

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Location

MeSH Terms

Conditions

StutteringCommunication Disorders

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Lucy E Paterson, MA, BSc

    Newcastle upon Tyne NHS Hospitals Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2009

First Posted

July 23, 2009

Study Start

June 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations