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Trial registered on ANZCTR


Registration number
ACTRN12615001276549
Ethics application status
Approved
Date submitted
1/10/2015
Date registered
23/11/2015
Date last updated
23/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Stress Reduction Treatments for Parents of Children with Intellectual Disabilities
Scientific title
A RCT comparing standard CBT with mindfulness-integrated CBT to reduce stress in Parents of Children with Intellectual Disability
Secondary ID [1] 287533 0
Nil
Universal Trial Number (UTN)
U1111-1174-8555
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 296300 0
Intellectual Disability 296301 0
Condition category
Condition code
Mental Health 296579 296579 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive behaviour therapy (CBT) is a psychotherapeutic treatment based on the interrelation of cognitions, behaviours and affective responses. In CBT, the therapist and client collaborate to identify and modify unhelpful patterns of thoughts and behaviours which may maintain distress. CBT skills are practiced both in session and at home to consolidate gains.

Mindfulness-integrated Cognitive Behaviour Therapy (MiCBT) integrates the teachings of mindfulness meditation practices with the core principles of CBT to address distress across a broad range of emotional and behavioural problems. Mindfulness skills include developing heightened sensory awareness of the present moment, disengagement from a cycle of judgement and reactivity to experience, and use of deliberate sustained attention to sensory and cognitive processes.

Both interventions above will be conducted in the form of group therapy sessions, held once a week over 8 weeks, with 2 additional weeks (before and immediately after the 8-week therapy program) to take baseline and post-test measures. Each session will be approximately 1.5 to 2 hours long, facilitated by Provisional Psychologists in the Master of Clinical Psychology, supervised by registered Psychologists and Clinical Psychologists. Participants will be encouraged to attend each session, and attendance will be monitored by therapy administrators through marking a roll each session. In both CBT and MiCBT, participants will be taught various techniques in session, and will be assigned home practice tasks based on the material discussed in session to complete in the following week. Participants are expected to complete approximately 30 minutes of home practice per week.
Intervention code [1] 292932 0
Treatment: Other
Intervention code [2] 292933 0
Behaviour
Comparator / control treatment
The research will compare two types of group programs (MiCBT and CBT). Both are existing treatments, and the study aims to directly compare the efficacy of these two treatments in this particular population.
Control group
Active

Outcomes
Primary outcome [1] 296198 0
Levels of stress in parents with children with intellectual disabilities, in CBT and MiCBT groups, assessed using mean scores on the Parenting Stress Index- Short Form (PSI-SF).
Timepoint [1] 296198 0
Pre-intervention and immediately post-intervention (8 weeks)
Secondary outcome [1] 317790 0
mean score on parental locus of control (Parental Locus of Control Scale Short Form Revised)
Timepoint [1] 317790 0
Pre-intervention and immediately post-intervention (8 weeks)
Secondary outcome [2] 317791 0
mean score on Kansas Inventory of Parental Perceptions (KIPP)
Timepoint [2] 317791 0
Pre-intervention and immediately post-intervention (8 weeks)
Secondary outcome [3] 317792 0
mean score on parental self-efficacy (Parental Sense of Competence Scale)
Timepoint [3] 317792 0
Pre-intervention and immediately post-intervention (8 weeks)
Secondary outcome [4] 317793 0
mean score on parenting styles (Parenting Styles and Dimensions Questionnaire)
Timepoint [4] 317793 0
Pre-intervention and immediately post-intervention (8 weeks)
Secondary outcome [5] 317794 0
mean score on treatment acceptability (Consumer Satisfaction Questionnaire-7)
Timepoint [5] 317794 0
Pre-intervention and immediately post-intervention (8 weeks)
Secondary outcome [6] 317795 0
mean score on parent well-being (Satisfaction with Life Scales)
Timepoint [6] 317795 0
Pre-intervention and immediately post-intervention (8 weeks)
Secondary outcome [7] 317796 0
mean score on Parenting Practices Interview
Timepoint [7] 317796 0
Pre-intervention and immediately post-intervention (8 weeks)
Secondary outcome [8] 317961 0
mean score on child behaviour problems (Child Behaviour Checklist and Behaviour Problems Inventory)
Timepoint [8] 317961 0
Pre-intervention and immediately post-intervention (8 weeks)
Secondary outcome [9] 317962 0
mean score on child adaptive behaviour (Vineland Adaptive Behaviour Scale).
Timepoint [9] 317962 0
Pre-intervention and immediately post-intervention (8 weeks)

Eligibility
Key inclusion criteria
Participants must be parents experiencing at least mild stress and have a child with an intellectual disability between the ages of 5-13 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any participants who do not meet the inclusion criteria will be excluded; that is, parents who are not experiencing stress, parents of children who do not have an intellectual disability, and parents of children who are not within the 5-13 year age range. Participants with suicidal intent, or a current or past diagnosis of psychotic illness or bipolar disorder will be excluded.

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)
Potential participants will be screened (inclusion and exclusion criteria). Participants will be allocated via simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to CBT or MiCBT groups through the use of a computerised randomiser.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was determined through use of previous literature on stress reduction to determine the average sample size observed in this area of research. A power analysis via the program G*Power (computerised statistical program, Universitat Dusseldorf) indicated that a sample size of 35 participants for group (total of 70 participants) was required for a large effect size with 80% power.
Further statistical analyses will be conducted using ANCOVA on post-intervention stress symptoms, holding constant pre-existing stress symptoms as co-variates. In addition, a correlational analysis will indicate which secondary measures may potentially contribute to the effect of CBT and MiCBT.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/01/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292142 0
Other
Name [1] 292142 0
Northern Intellectual Disability Health via University of Sydney
Country [1] 292142 0
Australia
Funding source category [2] 292146 0
University
Name [2] 292146 0
University of Technology Sydney
Country [2] 292146 0
Australia
Primary sponsor type
Other
Name
Northern Intellectual Disability Health
Address
231 Military Road, Cremorne NSW 2090
Country
Australia
Secondary sponsor category [1] 290817 0
University
Name [1] 290817 0
University of Technology
Address [1] 290817 0
15 Broadway, Ultimo, NSW 2007
Country [1] 290817 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293616 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 293616 0
Ethics committee country [1] 293616 0
Australia
Date submitted for ethics approval [1] 293616 0
Approval date [1] 293616 0
27/08/2015
Ethics approval number [1] 293616 0
LNR/15/HAWKE/263

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

Contacts
Principal investigator
Name 60570 0
Dr Lynette Roberts
Address 60570 0
Discipline of Clinical Psychology, Graduate School of Health
Level 4, Building 7, UTS
15 Broadway
Ultimo, NSW, 2007
Country 60570 0
Australia
Phone 60570 0
+61 2 9514 7202
Fax 60570 0
Email 60570 0
Lynette.Roberts@uts.edu.au
Contact person for public queries
Name 60571 0
Lynette Roberts
Address 60571 0
Discipline of Clinical Psychology, Graduate School of Health
Level 4, Building 7, UTS
15 Broadway
Ultimo, NSW, 2007
Country 60571 0
Australia
Phone 60571 0
+61 2 9514 7202
Fax 60571 0
Email 60571 0
Lynette.Roberts@uts.edu.au
Contact person for scientific queries
Name 60572 0
Lynette Roberts
Address 60572 0
Discipline of Clinical Psychology, Graduate School of Health
Level 4, Building 7, UTS
15 Broadway
Ultimo, NSW, 2007
Country 60572 0
Australia
Phone 60572 0
+61 2 9514 7202
Fax 60572 0
Email 60572 0
Lynette.Roberts@uts.edu.au

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.