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Trial registered on ANZCTR


Registration number
ACTRN12617001080314
Ethics application status
Approved
Date submitted
26/06/2017
Date registered
25/07/2017
Date last updated
12/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and acceptability of a mindfulness-based intervention for temper outbursts in Prader–Willi syndrome
Scientific title
Feasibility and acceptability of a mindfulness-based intervention for temper outbursts in Prader–Willi syndrome
Secondary ID [1] 292263 0
N/A
Universal Trial Number (UTN)
U1111-1198-2652
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prader-Willi syndrome 303803 0
Condition category
Condition code
Human Genetics and Inherited Disorders 303170 303170 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is called Meditation on the Soles of the Feet (SOF). It is a mindfulness-based training program designed for people with an intellectual disability. SoF teaches the person to recognise the precursors to their aggression, disengage attention from the emotionally arousing situation and redirect their attention to the soles of their feet. The primary caregiver will be trained by a member of the research team to personally use and to teach SoF to the person with PWS. Individual training sessions will be conducted via video conference over two half days in the two weeks prior to baseline. Each primary caregiver will be provided with a copy of the trainer’s manual (Singh et al., 2011), which includes step-by-step instructions for their own training and for training the person with PWS.
During the intervention period, the primary caregivers will use the 6-week training program, outlined in the trainer’s manual, to the person with PWS to implement SoF. Training will occur in the person’s home. Participants will be asked to participate in the training as many days as possible over the six weeks. Ideally, once a day. The training program breaks the intervention down into five steps. Participants are advised to work through each step at their own pace and to only progress through the steps when each one is successfully completed So, how often they do each step will vary across participants. The training session will take anywhere from 5 to 20 minutes, depending on how well the person is grasping the content. The five steps include: learning how to draw attention to their breath, learning how to draw attention to the soles of their feet, switching attention from a positive memory to the soles of their feet and then from a negative memory to their soles and finally how to redirect attention to the soles of their feet during times of anger.
The primary caregivers will be assessed by an expert SoF trainer (via video conferences) to ensure that they are competent in teaching the technique before the trial begins. Primary caregivers will then be asked to video record three training sessions that they conduct with the person with PWS at weeks one, three and six of the intervention period. A member of the research team will use the recordings to assess fidelity through a checklist. Caregivers will participate in weekly phone calls with the research team where they will be given feedback about their training and have an opportunity to ask questions. Caregivers will also be asked to keep a record of the number and length of the sessions and how many times they practised each step.

Singh, N. N., Singh, J., Singh, A. D. A., Singh, A. N. A., & Winton, A. S. W. (2011). Mediation of the Soles of the Feet for Anger Management: A Trainers Manual. Raleigh, NC: Fernleaf Publishing.
Intervention code [1] 298458 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302545 0
The Developmental Behaviour Checklist Monitor version (DBC-M) asks caregivers to rate specific behaviours as either 0 = not a problem; 1 = somewhat a problem; 2 = a major problem. The behaviours are selected from validated items on the Developmental Behaviour Checklist – Parent (Einfeld et al. 2002) and Adult (Mohr et al. 2011) versions. The DBC-M is a combined measure of the frequency and severity of behaviours. Primary caregivers will be asked to complete the DBC-M at the end of each day. This data will be used to determine whether the SoF intervention can reduce outburst and outburst-related behaviours.
A teacher or support worker at a day centre or place of employment will also be asked to complete the DBC-M on the days the person with PWS is at school/work/day centre. Teachers or support staff will be asked to rate the same behaviours as primary caregivers. This data will be used to determine whether the intervention can lead to a reduction in outburst related behaviours in environments beyond the home.
Timepoint [1] 302545 0
The DBC-M will be completed each day the primary caregiver and teacher or support worker sees the person with PWS during the 18-weeks (6week baseline, 6-week intervention, and 6 week follow-up periods). For some this maybe every day for others it may be three or four times a week.
Primary outcome [2] 302547 0
Feasibility: Feasibility will be assessed based on the following criteria:
1. successful recruitment of 10 participants
2. retention of 80% of participants over the 18 weeks.
3. 80% of DBC data from each participant
4. Fidelity recordings from at least 3 participants
5. Scores of 75% or higher on the fidelity checklist
Timepoint [2] 302547 0
At the end of the 18-week study, which will be 6 weeks post end of the intervention.
Primary outcome [3] 302548 0
Acceptability: Primary caregivers will be asked to complete a brief questionnaire to assess the acceptability of the training program and data collection. The questionnaire, designed specifically for this study, will ask primary caregivers questions about a number of training sessions they completed with the person with PWS, how engaged the person with PWS was in the sessions, how helpful they thought the intervention was for the person with PWS, whether the individual continued to practise mindfulness in the follow-up and whether there was anything that they liked, disliked or would change about the training program and data collection.
Timepoint [3] 302548 0
Participants will be sent this questionnaire immediately after the follow-up period, which is At 6 weeks post end of the intervention.
Secondary outcome [1] 336354 0
Rage Outbursts and Anger Rating Scale (ROARS) measures the frequency, duration and intensity of rages in the past week using three 4-point likert-scales. The psychometric properties of this measure have been assessed in children with OCD (Storch et al. 2012) and in a group of children and teens with varying psychiatric disorders (Nadeau et al. 2016). The measure has good divergent validity with the CGI-Rage as well as good internal consistency, inter-rater reliability and test re-test reliability. Primary caregivers will be interviewed each week by a member of the research team who will complete the ROARS.
Timepoint [1] 336354 0
Weekly during the 6-week baseline, 6-week intervention and 6-week follow-up periods.
Secondary outcome [2] 336355 0
Fidelity of SoF Training: Primary caregivers will be asked to record three training sessions, in the first, third and sixth week of training. The recordings will be used to assess the fidelity of the caregivers training of the person with PWS in the SoF procedure. A checklist completed by a member of the research team will be used to assess the fidelity.
Timepoint [2] 336355 0
In the first, third and sixth week during the 6 week intervention period

Eligibility
Key inclusion criteria
Person with PWS
1. Aged 13 to 30 years
2. Typical IQ or mild intellectual disability (Full IQ 50>). Determined through a copy of a cognitive assessment
3. PWS confirmed via a copy of a genetic report
4. The person currently displays at least two outbursts a week
Primary caregiver
1. Has known the person with PWS for at least 12 months.
2. Spends at least 5 days a week with the person with PWS. In residential settings, two care staff members may be enrolled into the study to share the primary caregiver role. In which case both staff members will be trained to provide the intervention.
Teacher/support staff
1. Sees the person with PWS at least three days a week
Minimum age
13 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
n/a

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
Single group
Other design features
All participants will be assigned to a six-week baseline period followed by six weeks of SoF training and six weeks of follow-up.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary caregiver completes the DBC-M at the end of each day. These scores will be summed up so each person has 18 weekly scores (6 weeks baseline, 6 weeks treatment and 6 weeks follow-up). These scores will then be used to calculate means for each participant in each condition (baseline, intervention). The same will be done for ratings provided by the teacher or support staff. The standard deviations for the baseline and treatment phase will be used to determine the sample size of a randomised control trial (RCT).
The fidelity checklist and feasibility and acceptability data will be summed up and descriptive data will be used to inform the study protocol for the RCT.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2018
Actual
Date of last participant enrolment
Anticipated
1/06/2019
Actual
Date of last data collection
Anticipated
31/08/2019
Actual
Sample size
Target
13
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 9018 0
New Zealand
State/province [1] 9018 0
Country [2] 9019 0
United Kingdom
State/province [2] 9019 0
Country [3] 9020 0
Canada
State/province [3] 9020 0
Country [4] 9021 0
United States of America
State/province [4] 9021 0

Funding & Sponsors
Funding source category [1] 296810 0
Charities/Societies/Foundations
Name [1] 296810 0
Foundation for Prader-Willi Syndrome
Country [1] 296810 0
United States of America
Primary sponsor type
University
Name
University of Sydney
Address
Level 6, Jane Foss Russell Building G02,
The University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 295798 0
None
Name [1] 295798 0
Address [1] 295798 0
Country [1] 295798 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298044 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 298044 0
Human Ethics Office
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 298044 0
Australia
Date submitted for ethics approval [1] 298044 0
26/06/2017
Approval date [1] 298044 0
29/11/2017
Ethics approval number [1] 298044 0
2017/795

Summary
Brief summary
Temper outbursts are a leading cause of morbidity for individuals with Prader-Willi syndrome (PWS). Despite this, there is currently no known treatment. Meditation on the Soles of the Feet (SoF) is a mindfulness-based intervention designed to help individuals with intellectual disability (ID) regulate their emotions during times of distress. Three single-case experimental studies suggest SoF can reduce physical and verbal aggression in adolescents with PWS. The present study aims to evaluate the feasibility and acceptability of the SoF intervention and data collection. Information collected in this study will be used to direct a wait-list randomised controlled trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75802 0
Prof Stewart Einfeld
Address 75802 0
Brain and Mind Centre
94 Mallett St
Camperdown
NSW 2050
Country 75802 0
Australia
Phone 75802 0
+61 2 9114 4106
Fax 75802 0
Email 75802 0
stewart.einfeld@sydney.edu.au
Contact person for public queries
Name 75803 0
Dr Lauren Rice
Address 75803 0
Brain and Mind Centre
94 Mallett St
Camperdown
NSW 2050
Country 75803 0
Australia
Phone 75803 0
+61 2 9114 4106
Fax 75803 0
Email 75803 0
lauren.rice@sydney.edu.au
Contact person for scientific queries
Name 75804 0
Dr Lauren Rice
Address 75804 0
Brain and Mind Centre
94 Mallett St
Camperdown
NSW 2050
Country 75804 0
Australia
Phone 75804 0
+61 2 9114 4106
Fax 75804 0
Email 75804 0
lauren.rice@sydney.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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