Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001654246p
Ethics application status
Submitted, not yet approved
Date submitted
3/10/2018
Date registered
5/10/2018
Date last updated
5/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Online Mindfulness Treatment for Reducing Stress for Parents of Children with Developmental Disabilities (DD)
Scientific title
Online Mindfulness Treatment for Reducing Stress for Parents of Children with Developmental Disabilities (DD)
Secondary ID [1] 296160 0
None
Universal Trial Number (UTN)
U1111-1221-6045
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 309894 0
Psychological Distress 309895 0
Condition category
Condition code
Mental Health 308680 308680 0 0
Other mental health disorders
Mental Health 308681 308681 0 0
Learning disabilities
Mental Health 308682 308682 0 0
Anxiety
Mental Health 308683 308683 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a trial of a 14 day online mindfulness trial for parents of children with developmental disabilities to see whether this treatment is acceptable to parents and effective in increasing mindfulness and reducing psychological distress.

The treatment involves reading information about mindfulness, and listening to a ten minute meditation recording each day for 14 days. Website analytics will track frequency and duration of listening to the recording, and participants will also complete outcome measures.
Intervention code [1] 312571 0
Treatment: Other
Comparator / control treatment
Treatment will be compared to a waitlist, and after 14 days the waitlist will have access to the same treatment as the treatment group
Control group
Active

Outcomes
Primary outcome [1] 307647 0
Participant change between and within groups on:
DASS-21
Timepoint [1] 307647 0
After treatment (primary time point), 3 months follow up and 12 months follow up
Primary outcome [2] 307667 0
Parenting Stress Index Short Form
Timepoint [2] 307667 0
After treatment (primary time point), 3 months follow up and 12 months follow up
Primary outcome [3] 307668 0
5 facet mindfulness questionnaire
Timepoint [3] 307668 0
After treatment (primary time point), 3 months follow up and 12 months follow up
Secondary outcome [1] 352497 0
Participant response on
Net promoter score
Timepoint [1] 352497 0
After treatment
Secondary outcome [2] 352528 0
Consumer Satisfaction Questionnaire 8
Timepoint [2] 352528 0
After treatment
Secondary outcome [3] 352529 0
Patient Health Questionnaire 9 (primary outcome)
Timepoint [3] 352529 0
After treatment (primary time point), 3 months follow up and 12 months follow up

Eligibility
Key inclusion criteria
• Parents of children with a developmental disability
• Australian resident
• Experiencing mild stress, with a score of at least 8 on the stress scale of the Depression Anxiety Stress Scales - DASS-21 (Lovibond & Lovibond 1995).
• Willingness to give written informed consent, and willingness to participate and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Overall score on the Patient Health Questionnaire - PHQ-9
• Score of above 2 on question 9 of the PHQ-9

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



Intervention assignment
Parallel
Other design features
Wait list control
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/11/2018
Actual
Date of last participant enrolment
Anticipated
1/07/2019
Actual
Date of last data collection
Anticipated
28/07/2020
Actual
Sample size
Target
170
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 300753 0
University
Name [1] 300753 0
University of Technology Sydney
Country [1] 300753 0
Australia
Primary sponsor type
University
Name
Graduate School of Health University of Technology Sydney
Address
67 Thomas Street
Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 300289 0
None
Name [1] 300289 0
Address [1] 300289 0
Country [1] 300289 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301530 0
UTS Human Research Ethics Committee
Ethics committee address [1] 301530 0
15 Broadway, Ultimo NSW 2007
Ethics committee country [1] 301530 0
Australia
Date submitted for ethics approval [1] 301530 0
17/09/2018
Approval date [1] 301530 0
Ethics approval number [1] 301530 0

Summary
Brief summary
The aim of this research is to see whether a self-guided online mindfulness intervention leads to an increase in mindfulness and reductions in anxiety/depressive and stress symptoms in parents of children with DD. Based on previous research involving online mindfulness interventions with the general population, we expect that parents of children with DD will experience increases in mindfulness and reductions in anxiety, depressive and stress symptoms as a result of the intervention. If this intervention leads to increases in mindfulness and reductions in symptoms of distress, and parents rate the intervention as acceptable, then these preliminary results would suggest e-treatment as a possible alternative to current face-to-face treatments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87306 0
Prof Ian Kneebone
Address 87306 0
Graduate School of Health
University of Technology Sydney
67 Thomas St Ultimo NSW, 2007
Country 87306 0
Australia
Phone 87306 0
+61 2 9514 4280
Fax 87306 0
Email 87306 0
[email protected]
Contact person for public queries
Name 87307 0
Ms Raphaella Osborn
Address 87307 0
Graduate School of Health
University of Technology Sydney
67 Thomas St Ultimo NSW, 2007
Country 87307 0
Australia
Phone 87307 0
+61 2 9514 4280
Fax 87307 0
Email 87307 0
[email protected]
Contact person for scientific queries
Name 87308 0
Ms Raphaella Osborn
Address 87308 0
Graduate School of Health
University of Technology Sydney
67 Thomas St Ultimo NSW, 2007
Country 87308 0
Australia
Phone 87308 0
+61 2 9514 4280
Fax 87308 0
Email 87308 0
[email protected]

No information has been provided regarding IPD availability


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.