Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000723987
Ethics application status
Approved
Date submitted
28/05/2020
Date registered
7/07/2020
Date last updated
3/12/2020
Date data sharing statement initially provided
7/07/2020
Date results provided
7/07/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of stuttering in school-aged children using The Camperdown Program and The Happiness Trap Pocketbook
Scientific title
An evaluation of the impact of a combined Camperdown Program with a self-help Acceptance and Commitment Therapy (ACT) program on stuttering severity in school-aged children who stutter
Secondary ID [1] 301551 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood stuttering 310043 0
Childhood anxiety 317918 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308794 308794 0 0
Speech therapy
Mental Health 315567 315567 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will collect outcome data for an individual treatment with supported self-help treatment. Treatment will involve student speech pathologists (supervised by the Clinical Educator who is also a member of the research team) facilitating the treatment. The treatment protocol involves teaching fluency techniques, addressing thoughts and feelings associated with stuttering, and individual goal setting. The individual treatment will be provided to 12 individuals using The Camperdown Program to address childhood stuttering and supported self-help using 'The Happiness Trap- Pocketbook Edition'. During the sessions with the student speech pathologists, participants will be taught prolonged speech techniques to control stuttering, using the Camperdown Program method. Participants will be assigned a chapter per night to read and complete the exercises in The Happiness Trap Pocketbook. The student speech pathologists will review The Happiness Trap Pocketbook exercises completed at home during the first third of the session, and spend the remainder of the session teaching and practising prolonged speech, and in later sessions, problem-solving transfer of skills beyond the clinic. In addition to completing the self-help exercises in The Happiness Trap Pocketbook, participants will also be requested to practise their prolonged speech technique between clinic visits.

Outcome measures will be obtained on 4 separate occasions: pre-treatment, immediately post-treatment, one month post-treatment and at a 9 month follow up session.

Treatment occurs twice per week for a total of 3 weeks duration. Treatment will be provided face-to-face at one of three locations: the Flinders University Fluency Clinics (Women's and Children's Hospital or Flinders Medical Centre) or a private practice 'Swift Speech and Stuttering'. The treatment program will be based on standard care but will be personalised dependent on the child and family/caregiver's goals.

Participants will complete a total of 10 study visits - one pre-treatment study visit, 6 treatment sessions (twice weekly for 3 weeks) and a further 3 post-treatment study visits immediately post-treatment, one month post-treatment and 9 months post-treatment.
Intervention code [1] 312657 0
Behaviour
Intervention code [2] 317591 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323849 0
Change in severity rating (0-8 scale) as used in The Camperdown Program, which measures the global severity of overt stuttering including frequency and type of stutters as well as any superfluous behaviours present (e.g., eye blinks, head nods and similar).
Timepoint [1] 323849 0
pre-treatment (baseline)
immediately post-treatment completion
one month post-treatment completion
nine months post-treatment completion
Primary outcome [2] 323850 0
Change in Overall Assessment of the Speaker's Experience of Stuttering - School-aged (OASES-S) impact rating which assesses the impact of stuttering on the speaker's reactions, daily communication and quality of life.
Timepoint [2] 323850 0
pre-treatment (baseline)
immediately post-treatment completion
one month post-treatment completion
nine months post-treatment completion
Primary outcome [3] 323851 0
Change in Social Phobia and Anxiety Inventory for Children (SPAI-C) score, which assesses levels of social phobia and anxiety.
Timepoint [3] 323851 0
pre-treatment (baseline)
immediately post-treatment completion
one month post-treatment completion
nine months post-treatment completion
Secondary outcome [1] 383057 0
Change in perceived difficulties and negative attitude towards communication through changes in the Communication Attitude Test (CAT) score.
Timepoint [1] 383057 0
pre-treatment (baseline)
immediately post-treatment completion
one month post-treatment completion
nine months post-treatment completion
Secondary outcome [2] 383058 0
Change in parental knowledge and confidence regarding their child's stuttering, and the parent's perspective of the child's stuttering, through changes in the Palin Parent Rating Scales scores.
Timepoint [2] 383058 0
pre-treatment (baseline)
immediately post-treatment completion
one month post-treatment completion
nine months post-treatment completion
Secondary outcome [3] 383059 0
Change in levels of social phobia, through changes in the Social Phobia Inventory (SPIN) scores.
Timepoint [3] 383059 0
pre-treatment (baseline)
immediately post-treatment completion
one month post-treatment completion
nine months post-treatment completion
Secondary outcome [4] 383060 0
Changes in levels of anxiety, through changes in the Spence Children's Anxiety Scale score.
Timepoint [4] 383060 0
pre-treatment (baseline)
immediately post-treatment completion
one month post-treatment completion
nine months post-treatment completion

Eligibility
Key inclusion criteria
• Age, between 8;0 and 12;0 years old
• Stuttering Severity Rating of 2 or above
• Overall score on the OASES-S of ‘mild to moderate’ or higher
• A level of English proficiency that enables participation in individual treatment without the use of an interpreter
• Written consent
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Critical realistic evaluation methodology is the analysis approach used in this study. It provides a holistic approach towards the analysis of the proposed intervention by analysing the various contexts and mechanisms that give rise to positive and negative outcomes and expresses these in the form of Context-Mechanism-Outcome (CMO) configurations or hypotheses. The formulation of CMO hypotheses occurs via semi-structured interviews, supported with quantitative data from various speech, communication and anxiety measures. To form the CMO configurations the data from each participant is entered into a Participation Matrix. The Participation Matrix is a combination of demographic data, quantitative data results, as well as the qualitative data analysis (thematic analysis coding). These contexts, mechanisms and outcomes are combined for each participant and across participants to formulate CMO hypotheses.
Twelve participants were chosen as the target participant number as there is research supporting the achievement of saturation or near-saturation of qualitative data after 12 participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/04/2019
Date of last participant enrolment
Anticipated
Actual
8/05/2019
Date of last data collection
Anticipated
13/07/2020
Actual
8/07/2020
Sample size
Target
12
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 12177 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 12178 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 24345 0
5006 - North Adelaide
Recruitment postcode(s) [2] 24346 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 300926 0
University
Name [1] 300926 0
Flinders University
Country [1] 300926 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders Drive
BEDFORD PARK, SA, 5042
Country
Australia
Secondary sponsor category [1] 300492 0
None
Name [1] 300492 0
None
Address [1] 300492 0
None
Country [1] 300492 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301697 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 301697 0
Ethics committee country [1] 301697 0
Australia
Date submitted for ethics approval [1] 301697 0
26/09/2018
Approval date [1] 301697 0
06/03/2019
Ethics approval number [1] 301697 0
HREC/18/WCHN/127

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87810 0
Dr Michelle Swift
Address 87810 0
Speech Pathology Flinders University
GPO Box 2100
ADELAIDE SA 5001
Country 87810 0
Australia
Phone 87810 0
+61 436202121
Fax 87810 0
Email 87810 0
[email protected]
Contact person for public queries
Name 87811 0
Michelle Swift
Address 87811 0
Speech Pathology Flinders University
GPO Box 2100
ADELAIDE SA 5001
Country 87811 0
Australia
Phone 87811 0
+61 436202121
Fax 87811 0
Email 87811 0
[email protected]
Contact person for scientific queries
Name 87812 0
Michelle Swift
Address 87812 0
Speech Pathology Flinders University
GPO Box 2100
ADELAIDE SA 5001
Country 87812 0
Australia
Phone 87812 0
+61 436202121
Fax 87812 0
Email 87812 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified transcripts of the interviews and speech samples.
When will data be available (start and end dates)?
Immediately after publication and available for 7 years after publication.
Available to whom?
Researchers with a methodologically sound proposal
Available for what types of analyses?
Linguistic analyses, critical realistic evaluation, qualitative analyses
How or where can data be obtained?
Access via approval of Principal Investigator - Dr Michelle Swift - [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.