StutteringPhase 2NCT00709072
Follow-up of Children After Stuttering Treatment
A Phase 2 study testing SMS (Short Message Service) reminders in people with Stuttering, run by University of Sydney at 1 site in Australia.
Trial summary
This study aims to determine the percentage and predictors of stuttering relapse following treatment with the Lidcombe Program. It will also investigate the effectiveness of sending reminder messages to parents to assist in reducing relapse. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Stuttering
- What is being tested?
- SMS (Short Message Service) reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2009to Dec 2011
- Phase
- Phase 2
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Completion of stage I of Lidcombe Program
- Less than 1 percent syllables stuttered at recruitment
- Means of receiving SMS email or phone reminder
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Australian Stuttering Research Centre
Sydney, New South Wales, 1825
Mark Onslow, PhD, 61 2 9351 9061, M.Onslow@usyd.edu.au
About this study
Official title: Relapse Following the Lidcombe Program for Preschool Children Who Stutter
This study aims to determine the percentage and predictors of stuttering relapse following treatment with the Lidcombe Program. It will also investigate the effectiveness of sending reminder messages to parents to assist in reducing relapse.
Read the detailed description
Stuttering treatment becomes more time-consuming and less effective as children become older. Therefore it is crucial to prevent relapse following treatment in the early years. This study will investigate predictors of relapse and assess the effectiveness of a simple two-weekly user-friendly reminder to parents, about when and how to address any re-occurring stuttering after treatment. Results from the study may help to prevent stuttering relapse in this age group in the future.
- Conditions
- Stuttering
- Being tested
- SMS (Short Message Service) reminders
- Keywords
- stuttering, relapse, Lidcombe Program, Preschool children
- Medical subject headings
- Stuttering, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS (Short Message Service) remindersBehavioural
SMS reminders sent every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SMS reminders Receives: Behavioral: SMS (Short Message Service) reminders |
| 2 | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of syllables stuttered
Measured: six monthly for three years
Secondary outcomes (1)
parent reported stuttering severity
Measured: six monthly for three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startFeb 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StutteringStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Investigators
- Mark Onslow, PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709072
- Sponsor's protocol ID
- 10483
- Status last verified
- Jun 2009
- First submitted
- 1 Jul 2008
- Last updated
- 26 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relapse Following the Lidcombe Program for Preschool Children Who Stutter
- ClinicalTrials.gov ID
- NCT00709072
- Acronym / sponsor ID
- 10483
- Conditions
- Stuttering
- Keywords
- stuttering, relapse, Lidcombe Program, Preschool children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 3 Jul 2008 (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.
This study aims to determine the percentage and predictors of stuttering relapse following treatment with the Lidcombe Program. It will also investigate the effectiveness of sending reminder messages to parents to assist in reducing relapse.
Detailed description
Stuttering treatment becomes more time-consuming and less effective as children become older. Therefore it is crucial to prevent relapse following treatment in the early years. This study will investigate predictors of relapse and assess the effectiveness of a simple two-weekly user-friendly reminder to parents, about when and how to address any re-occurring stuttering after treatment. Results from the study may help to prevent stuttering relapse in this age group in the future.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: SMS (Short Message Service) remindersSMS reminders |
| 2 | No intervention | –control group |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Completion of stage I of Lidcombe Program
- Less than 1 percent syllables stuttered at recruitment
- Means of receiving SMS email or phone reminder
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SMS (Short Message Service) remindersSMS reminders sent every 2 weeks | Behavioural | 1 |
Primary outcome
percentage of syllables stuttered
Time frame: six monthly for three years
1 secondary outcome
parent reported stuttering severity
Time frame: six monthly for three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2010.
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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.
Mark Onslow, PhD principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SMS (Short Message Service) reminders in people with Stuttering, run by University of Sydney at 1 site in Australia.
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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 26 Apr 2010. 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 Australia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of syllables stuttered (time frame: six monthly for three years). 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 26 Apr 2010.