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Feasibility and acceptability of a mindfulness-based intervention for temper outbursts in Prader–Willi syndrome

Feasibility and acceptability of a mindfulness-based intervention for temper outbursts in Prader–Willi syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001080314
Enrollment
0
Registered
2017-07-25
Start date
2018-07-01
Completion date
2019-06-01
Last updated
2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 trai

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.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
13 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

n/a

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026