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Trial registered on ANZCTR


Registration number
ACTRN12618000986279
Ethics application status
Approved
Date submitted
12/04/2018
Date registered
12/06/2018
Date last updated
13/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Early Parenting Acceptance and Commitment Therapy ‘Early PACT’ for parents of infants with cerebral palsy
Scientific title
Early Parenting Acceptance and Commitment Therapy ‘Early PACT’ for parents of infants with cerebral palsy: A randomised controlled trial
Secondary ID [1] 294582 0
None
Universal Trial Number (UTN)
Trial acronym
Early PACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 307370 0
Mental Health 307371 0
Condition category
Condition code
Neurological 306476 306476 0 0
Other neurological disorders
Mental Health 306477 306477 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early PACT is a parenting intervention grounded in Acceptance and Commitment Therapy for parents of children with Cerebral Palsy. Early 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. Early PACT is provided as an online course via the edX platform, an open source course management system created by founding partners Harvard and MIT (www.edx.org/). The course incorporates virtual written text, video presentations, screen-based interactive activities, journal activities, reflections, guided experiential and mindfulness exercises and participation in a moderated discussion board. The course is offered to participants as three modules plus a review session four weeks after the final module. Modules are scheduled to be completed each fortnight, with a four-week break after that to allow for practice of the materials from the course (10 weeks total), with flexibility to move through content. Modules contain content exploring the parent’s values, thoughts and feelings, mindfulness techniques, ways to meet their child’s needs, and exercises for learning compassion. Modules contain videos for parents to watch and reflective exercises on what they have been shown gearing toward practice with their own child. Adherence to the course is monitored via website analytics, the coordinator can access information on whether participants have completed the course and assessments. Regular contact via phone with the parent will also occur to monitor their progress and adherence to the study.
Intervention code [1] 300876 0
Behaviour
Comparator / control treatment
This study is a Randomised Control Trial (RCT) following CONSORT (Consolidated Standards of Reporting Trials) guidelines. Parents of infants aged < 24 months C.A with CP will be randomly allocated to one of two groups:
(1) Immediate allocation to Early Parenting Acceptance and Commitment Therapy (Early PACT) in the form of the online course
(2) Wait-list control (usual-care); Early PACT will commence after a 3 month waiting time
Follow up will occur at 6 months post intervention (retention). All families will receive the intervention.
Usual care includes the medical, physiotherapy, or occupational therapy support the child is receiving and and self-driven or social supports the parents may have sought.
Control group
Active

Outcomes
Primary outcome [1] 305493 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] 305493 0
Conducted at baseline, post review (ten weeks after course commencement) [primary time point], and at six-months post intervention follow up
Primary outcome [2] 305495 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] 305495 0
Conducted at baseline, post review (ten weeks after course commencement) [primary time point], and at six-months post intervention follow up.
Secondary outcome [1] 345442 0
Parental psychological flexibility as measured by the Acceptance and Action Questionnaire (Bond et al., 2011).
Timepoint [1] 345442 0
Conducted at baseline, post review (ten weeks after course commencement), and at six-months post intervention follow up.
Secondary outcome [2] 345443 0
Parent symptoms of post traumatic stress as measured by the PTSD Checklist for DSM-5 (PCL-5) (Weathers et al., 2013).
Timepoint [2] 345443 0
Conducted at baseline, post review (ten weeks after course commencement), and at six-months post intervention follow up.
Secondary outcome [3] 345444 0
Parenting mindfulness assessed by the Interpersonal Mindfulness in Parenting Scale (IM-P) (Duncan, 2007).
Timepoint [3] 345444 0
Conducted at baseline, post review (ten weeks after course commencement), and at six-months post intervention follow up.
Secondary outcome [4] 345445 0
Parental psychological symptoms assessed by the parent-report Depression Anxiety Stress Scale (DASS-21) (Lovibond & Lovibond, 1995).
Timepoint [4] 345445 0
Conducted at baseline, post review (ten weeks after course commencement), and at six-months post intervention follow up.
Secondary outcome [5] 345446 0
Parent wellbeing as measured by the Personal Wellbeing Index (International Wellbeing Group, 2013).
Timepoint [5] 345446 0
Conducted at baseline, post review (ten weeks after course commencement), and at six-months post intervention follow up.
Secondary outcome [6] 345447 0
Infant quality of life as measured by parent report on the Infant Toddler Quality of Life Questionnaire™ (ITQOL-SF47) (Raat, Landgraf, Oostenbrink, Moll, & Essink-Bot, 2007).
Timepoint [6] 345447 0
Conducted at baseline, post review (ten weeks after course commencement), and at six-months post intervention follow up.
Secondary outcome [7] 345448 0
Infant’s adaptive behaviours as measured by parent report on the Infant Toddler Social Emotional Assessment (ITSEA) (Carter, Briggs-Gowan, Jones, & Little, 2003).
Timepoint [7] 345448 0
Conducted at baseline, post review (ten weeks after course commencement), and at six-months post intervention follow up.
Secondary outcome [8] 345449 0
Infant functional delay as measured by parent report on the Pediatric Evaluation of Disability Inventory, computer adaptive test (PEDI-CAT) (Shore et al., 2017).
Timepoint [8] 345449 0
Conducted at baseline, post review (ten weeks after course commencement), and at six-months post intervention follow up.

Eligibility
Key inclusion criteria
Parents of infants (< 24 months C.A) recognized as “high risk of cerebral palsy” based on General Movements (GMs) and Hammersmith Infant Neurological Examination (HINE) assessments will be recruited.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents will be excluded if they are unable to complete the Early PACT course, for example, if they have insufficient English language ability or lack of reliable internet access, email and mobile phone 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: Early PACT course immediate 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
Not yet recruiting
Date of first participant enrolment
Anticipated
2/07/2018
Actual
Date of last participant enrolment
Anticipated
28/06/2019
Actual
Date of last data collection
Anticipated
31/01/2020
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10638 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [2] 10639 0
Cairns Base Hospital - Cairns
Recruitment hospital [3] 10640 0
Gold Coast Hospital - Southport
Recruitment hospital [4] 10641 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [5] 10642 0
Mackay Base Hospital - Mackay
Recruitment hospital [6] 10643 0
Mount Isa Base Hospital - Mount Isa
Recruitment hospital [7] 10644 0
The Sunshine Coast Private Hospital - Buderim
Recruitment hospital [8] 10645 0
Thursday Island Hospital - Thursday Island
Recruitment postcode(s) [1] 22358 0
4101 - South Brisbane
Recruitment postcode(s) [2] 22359 0
4870 - Cairns
Recruitment postcode(s) [3] 22360 0
4215 - Southport
Recruitment postcode(s) [4] 22361 0
4029 - Herston
Recruitment postcode(s) [5] 22362 0
4740 - Mackay
Recruitment postcode(s) [6] 22363 0
4825 - Mount Isa
Recruitment postcode(s) [7] 22364 0
4556 - Buderim
Recruitment postcode(s) [8] 22365 0
4875 - Thursday Island

Funding & Sponsors
Funding source category [1] 299199 0
Charities/Societies/Foundations
Name [1] 299199 0
Cerebral Palsy Alliance
Country [1] 299199 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] 298462 0
None
Name [1] 298462 0
Address [1] 298462 0
Country [1] 298462 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300123 0
Childrens Health Queensland Hospital and Health Service
Ethics committee address [1] 300123 0
Ethics committee country [1] 300123 0
Australia
Date submitted for ethics approval [1] 300123 0
26/03/2018
Approval date [1] 300123 0
10/05/2018
Ethics approval number [1] 300123 0
HREC/18/QRCH/82

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

Contacts
Principal investigator
Name 82642 0
Dr Koa Whittingham
Address 82642 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 82642 0
Australia
Phone 82642 0
+61409260428
Fax 82642 0
Email 82642 0
koawhittingham@uq.edu.au
Contact person for public queries
Name 82643 0
Koa Whittingham
Address 82643 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 82643 0
Australia
Phone 82643 0
+61409260428
Fax 82643 0
Email 82643 0
koawhittingham@uq.edu.au
Contact person for scientific queries
Name 82644 0
Koa Whittingham
Address 82644 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 82644 0
Australia
Phone 82644 0
+61409260428
Fax 82644 0
Email 82644 0
koawhittingham@uq.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23620Study protocol    No attachment or link is available at this time. T... [More Details]

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEarly Parenting Acceptance and Commitment Therapy a Early PACT' for parents of infants with cerebral palsy: A study protocol of a randomised controlled trial.2020https://dx.doi.org/10.1136/bmjopen-2020-037033
N.B. These documents automatically identified may not have been verified by the study sponsor.