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Trial registered on ANZCTR


Registration number
ACTRN12616000351415
Ethics application status
Approved
Date submitted
16/02/2016
Date registered
18/03/2016
Date last updated
1/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Parenting Acceptance and Commitment Therapy (PACT): an innovative online course for families of children with Cerebral Palsy
Scientific title
Parenting Acceptance and Commitment Therapy: A randomised controlled trial of an innovative online course for families of children with Cerebral Palsy
Secondary ID [1] 288158 0
None
Universal Trial Number (UTN)
Trial acronym
PACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 297296 0
mental health 298028 0
Condition category
Condition code
Neurological 297493 297493 0 0
Other neurological disorders
Mental Health 298182 298182 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PACT is a parenting intervention grounded in Acceptance and Commitment Therapy for parents of children with Cerebral Palsy. PACT includes ACT technologies already established in an RCT as effective with families of children with CP, including mindfulness, experiential acceptance and cognitive defusion (Whittingham et al., 2014; Whittingham et al., in press; Whittingham, Sanders, et al., 2013). It includes some techniques from the established parenting literature but focuses on strategies to enhance the parent-child relationship and promote parental emotional responsiveness. An online course was created using an open source course management system for the purpose of the current study. The course incorporates: virtual written text, video presentations, screen-based interactive activities, journal activities, reflections, guided experiential and mindfulness exercises and participation in moderated discussion board. The course is offered as three modules with a fortnight to complete the content of each module and a four week break after that to allow for practise of the materials from the course. Overall the course lasts for 10 weeks), Parents will be able to move through each module's content with some flexibility. In addition, research participants will be offered Skype/phone sessions with a therapist as well as reminder text messages and emails. Skype/phone sessions will be offered weekly and up to 30 minutes in length, however the exact frequency and duration will vary according to participant need. Completion of activities within the course will be monitored.
Intervention code [1] 293624 0
Behaviour
Comparator / control treatment
The study is a randomised controlled trial following CONSORT (Consolidated Standards of Reporting Trials) guidelines. Parents of children with CP will be randomly allocated to one of two groups:
(1) Online Parenting Acceptance and Commitment Therapy (PACT)
(2) Wait-list control
Follow up will occur at 6 months post intervention (retention). The wait-list condition will be offered the intervention after completion of the review assessment.
Control group
Active

Outcomes
Primary outcome [1] 297055 0
Emotional availability within the parent-child relationship, assessed by the Emotional Availability Scales, (Biringen, Fidler, Barrett, & Kubicek, 2005; Biringen, Robinson, & Emde, 1998)
Timepoint [1] 297055 0
Conducted at baseline, post review (ten weeks after course commencement), and at six-months post intervention follow up
Secondary outcome [1] 319927 0
Parenting mindfulness assessed by the Interpersonal Mindfulness in Parenting Scale (IM-P) (Duncan, 2007)
Timepoint [1] 319927 0
Conducted at baseline, post review (ten weeks after course commencement), and at six-months post intervention follow up
Secondary outcome [2] 320186 0
Parent's perception of emotional availability within the parent-child relationship assessed by the Emotional Availability-Self Report (Vliegen, Luyten, & Biringen, 2009)
Timepoint [2] 320186 0
Conducted at baseline, post review (ten weeks after course commencement), and at six-months post intervention follow up
Secondary outcome [3] 320187 0
Parental psychological symptoms assessed by the parent-report Depression Anxiety Stress Scale (DASS-21) (Lovibond & Lovibond, 1995)
Timepoint [3] 320187 0
Conducted at baseline, post review (ten weeks after course commencement), and at six-months post intervention follow up
Secondary outcome [4] 320190 0
Child behavioural and emotional difficulties assessed by the parent-report Strengths and Difficulties Questionnaire (Goodman, 1997)
Timepoint [4] 320190 0
Conducted at baseline, post review (ten weeks after course commencement), and at six-months post intervention follow up
Secondary outcome [5] 320203 0
Child motor functioning assessed by the parent-report Gross Motor Function Classification System (GMFCS), (Palisano, 1997)
Timepoint [5] 320203 0
Conducted at baseline, post review (ten weeks after course commencement), and at six-months post intervention follow up
Secondary outcome [6] 335558 0
Parent wellbeing as measured by the Personal Wellbeing Index (International Wellbeing Group, 2013)
Timepoint [6] 335558 0
Conducted at baseline, post review (ten weeks after course commencement), and at six-months post intervention follow up
Secondary outcome [7] 335559 0
Parental psychological flexibility as measured by the Acceptance and Action Questionnaire (Bond et al., in press)
Timepoint [7] 335559 0
Conducted at baseline, post review (ten weeks after course commencement), and at six-months post intervention follow up

Eligibility
Key inclusion criteria
Parents with a child (2-­6 years old) with Cerebral Palsy. As PACT uses integrated web-based delivery parents are required to have: (1) reliable internet access at home (e.g. ADSL) and be committed to maintaining internet access for the duration of the study; (2) a mobile phone for receiving text messages; (3) an email address for receiving emails; and (4) access to Skype.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents will be excluded if they are unable to complete PACT, for example, do to insufficient English language ability or lack of reliable internet access.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes will be used to ensure that the investigator or staff member determining of a participant is eligible will be unaware, when this decision is made, to which group the participant would be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Participants are assigned to one of two groups: PACT or a wait-list control group.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
To have sufficient power to detect an effect size of 0.40 (power 0.8) a total sample size of 52 is required. If a conservative retention rate of 80% is assumed this leads to a total of 66 families to be recruited.

Analysis will follow standard methods for randomised controlled trials using comparisons between the two groups. Initially the two groups will be assessed to determine if they differ on key variables at baseline and covariates will be used to control for this in post-intervention analyses if necessary. The protocol of intention-to-treat analysis will be followed in order to minimise inflation of treatment effects consistent with CONSORT guidelines. The experimental unit will be the family represented by parent-reported data. Attrition analysis will be conducted, although strategies will be used in order to minimise missing data and attrition. Data will be analysed using SPSS. The hypotheses relating to intervention efficacy will be tested using general linear models, specifically via ANOVA or ANCOVA. Where continuous data exhibit substantial skewness not overcome by transformation, non-parametric methods will be used for simple comparisons.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5119 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [2] 5120 0
Mater Mother's Hospital - South Brisbane
Recruitment hospital [3] 5121 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 5122 0
The Townsville Hospital - Douglas
Recruitment hospital [5] 5123 0
Gold Coast Hospital - Southport
Recruitment postcode(s) [1] 12585 0
4006 - Herston
Recruitment postcode(s) [2] 12584 0
4101 - South Brisbane
Recruitment postcode(s) [3] 12587 0
4215 - Southport
Recruitment postcode(s) [4] 12586 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 292763 0
Charities/Societies/Foundations
Name [1] 292763 0
Cerebral Palsy Alliance
Address [1] 292763 0
187 Allambie Rd, Allambie Heights, NSW 2100
PO Box 6427, Frenchs Forest, NSW 2086
Country [1] 292763 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St Lucia 4067
Country
Australia
Secondary sponsor category [1] 291497 0
None
Name [1] 291497 0
Address [1] 291497 0
Country [1] 291497 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294250 0
Children’s Health Queensland Hospital and Health Service Human Research Committee
Ethics committee address [1] 294250 0
501 Stanley Street
South Brisbane
Queensland 4101
Ethics committee country [1] 294250 0
Australia
Date submitted for ethics approval [1] 294250 0
Approval date [1] 294250 0
08/08/2015
Ethics approval number [1] 294250 0
Ethics committee name [2] 294251 0
University of Queensland Institutional Human Research Ethics Approval
Ethics committee address [2] 294251 0
Ethics committee country [2] 294251 0
Australia
Date submitted for ethics approval [2] 294251 0
Approval date [2] 294251 0
09/11/2015
Ethics approval number [2] 294251 0

Summary
Brief summary
Our aim is to design and pilot an innovative, translatable ­by design online parenting support package: Parenting Acceptance and Commitment Therapy (PACT) for families of young children with CP. We will pilot PACT in a
randomised controlled trial recruiting 66 families of children with CP (2-6yo). We predict that PACT will be associated with improvements in the parent-child relationship, in child functioning, and in both parent and child 
adjustment and quality of life. Outcomes will be assessed immediately post-intervention and at 6 months post-intervention (retention). 
Trial website
Trial related presentations / publications

Public notes

Contacts
Principal investigator
Name 62230 0
Dr Koa Whittingham
Address 62230 0
Queensland Cerebral Palsy and Rehabilitation Research Centre (QCPRRC)
Level 6, Centre for Children's Health Research (CCRI)
62 Graham Street South Brisbane QLD 4101
Country 62230 0
Australia
Phone 62230 0
+61 7 3069 7346
Fax 62230 0
Email 62230 0
koawhittingham@uq.edu.au
Contact person for public queries
Name 62231 0
Dr Koa Whittingham
Address 62231 0
Queensland Cerebral Palsy and Rehabilitation Research Centre (QCPRRC)
Level 6, Centre for Children's Health Research (CCRI)
62 Graham Street South Brisbane QLD 4101
Country 62231 0
Australia
Phone 62231 0
+61 7 3069 7346
Fax 62231 0
Email 62231 0
koawhittingham@uq.edu.au
Contact person for scientific queries
Name 62232 0
Dr Koa Whittingham
Address 62232 0
Queensland Cerebral Palsy and Rehabilitation Research Centre (QCPRRC)
Level 6, Centre for Children's Health Research (CCRI)
62 Graham Street South Brisbane QLD 4101
Country 62232 0
Australia
Phone 62232 0
+61 7 3069 7346
Fax 62232 0
Email 62232 0
koawhittingham@uq.edu.au

No information has been provided regarding IPD availability
Summary results
No Results