Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001244594p
Ethics application status
Submitted, not yet approved
Date submitted
4/09/2024
Date registered
10/10/2024
Date last updated
10/10/2024
Date data sharing statement initially provided
10/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of CP-KASP (Cerebral Palsy Knowledge, Advocacy Skills, and Support Program) on parenting stress, empowerment and efficacy, and quality of life in caregivers of children with cerebral palsy.
Scientific title
Impact of CP-KASP (Cerebral Palsy Knowledge, Advocacy Skills, and Support Program) on parenting stress, empowerment and efficacy, and quality of life in caregivers of children with cerebral palsy.
Secondary ID [1] 312367 0
Nil known
Universal Trial Number (UTN)
U1111-1309-4769
Trial acronym
CP-KASP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 334156 0
Children with disabilities 334158 0
Condition category
Condition code
Neurological 330827 330827 0 0
Other neurological disorders
Musculoskeletal 330828 330828 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CP-KASP is a co-designed peer-to-peer delivered knowledge and support platform to equip families of young children with cerebral palsy (CP) to optimise and improve their engagement and experience with the National Disability Insurance Scheme (NDIS) in Australia. The content of CP-KASP will be determined by the co-designers, but it is envisaged that it will cover: (1) advocacy skills; (2) systems navigation of the NDIS; (3) evidence-based early intervention in CP; (4) setting therapy goals; (5) considerations for transition to primary school. CP-KASP will be delivered online (zoom) to groups of up to 10 caregivers. Content will include webinars and interactive sessions. Sessions will be for 2 hours/week over a 6 week period.
The co-design process commences with separate focus groups with consumer co-designers (n=10) and allied health co-designers (n=10) . The aim of the focus groups is to explore knowledge, skills, and support needs of caregivers of children with CP navigating the NDIS, understand CP specific knowledge and support needs to shape NDIS care packages for evidence-based early intervention, understand preferred methods of accessing information/supports. Results from this phase will inform the next co-design phase. A series of 8 workshops will be conducted, with co-designers working in small groups to develop the content for modules of CP-KASP. This could include content to build advocacy skills and CP specific evidence-based modules. These workshops will define the overarching program framework (e.g. length of time, mode (i.e webinars), content and format for interactive peer-led sessions.
Fidelity: Fidelity checklists will be developed, related to content delivery of CP-KASP. The following outcomes will be captured: (a) number of sessions attended; (b) percentage of content per session delivered as intended. An a priori cut-off score for high fidelity of delivery was established as greater than 80%, moderate as between 50% and 80% and low less than 50% of content delivered.
Intervention code [1] 328867 0
Behaviour
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338594 0
Parental Empowerment and Efficacy Measure
Timepoint [1] 338594 0
Parent outcomes will be administered at baseline prior to receiving CP-KASP, post receipt and then 6 months later.
Primary outcome [2] 338595 0
Parenting stress
Timepoint [2] 338595 0
Parent outcomes will be administered at baseline prior to receiving CP-KASP, post receipt and then 6 months later.
Primary outcome [3] 338596 0
Family Qality of Life Measure
Timepoint [3] 338596 0
Parent outcomes will be administered at baseline prior to receiving CP-KASP, post receipt and then 6 months later.
Secondary outcome [1] 436523 0
Child's Goal attainment
Timepoint [1] 436523 0
Child-related outcomes will be measured following the receipt of CP-KASP and then 6 months later.
Secondary outcome [2] 436524 0
The child’s quality of life
Timepoint [2] 436524 0
Child-related outcomes will be measured following the receipt of CP-KASP and then 6 months later.
Secondary outcome [3] 439389 0
Acceptability of CP-KASP
Timepoint [3] 439389 0
Immediately post receipt of CP-KASP
Secondary outcome [4] 440039 0
CP-KASP Questionnaire
Timepoint [4] 440039 0
Baseline, immediately post receipt and then 6 months later
Secondary outcome [5] 440040 0
Feasibility
Timepoint [5] 440040 0
Collected throughout duration of study
Secondary outcome [6] 440041 0
Appropriateness which is understanding the perceived fit including CP-KASPS relevance and suitability
Timepoint [6] 440041 0
Immediately post receipt of CP-KASP
Secondary outcome [7] 440298 0
Fidelity: number of sessions attended; % content per session delivered as intended.
Timepoint [7] 440298 0
Throughout each session of CP-KASP
Secondary outcome [8] 440299 0
Acceptability including aspects of delivery, content and complexity
Timepoint [8] 440299 0
Immediately post receipt of CP-KASP

Eligibility
Key inclusion criteria
Caregivers of children with CP aged < 6 years entering or using the NDIS system in Queensland or New South Wales. Participants will be recruited using maximum variation sampling for the severity of CP as per Gross Motor Function Classification System levels (I-V), geographic location (metropolitan, regional, remote across Queensland and New South Wales) through our community partners, early diagnostic clinics run by Children’s Health Queensland, Queensland Children’s Hospital, Queensland Early Detection and Intervention Network and Cerebral Palsy Alliance.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All caregivers will have a child with CP. Caregivers themselves may be healthy.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Depending data distribution, paired sample t-tests or Wilcoxon signed rank tests will be used for pre-post data. Qualitative data will be analysed inductively and deductively using interpretive description. Qualitative and quantitative data will be triangulated to report on the implementation outcomes. Trustworthiness will be maintained using member checking of interview transcripts and analysis summaries, oversight by experienced researchers in qualitative and mixed methods, and reflection by the research team with consideration given to power relations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2026
Actual
Date of last participant enrolment
Anticipated
1/09/2026
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 26711 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 27070 0
Cerebral Palsy Alliance - Allambie Heights
Recruitment postcode(s) [1] 42750 0
4101 - South Brisbane
Recruitment postcode(s) [2] 43137 0
2100 - Allambie Heights

Funding & Sponsors
Funding source category [1] 316775 0
Government body
Name [1] 316775 0
Department of Health and Aged Care: Medical Future Research Fund Consumer-Led Grant APP2028202
Country [1] 316775 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 318993 0
None
Name [1] 318993 0
Address [1] 318993 0
Country [1] 318993 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315543 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 315543 0
Ethics committee country [1] 315543 0
Australia
Date submitted for ethics approval [1] 315543 0
21/06/2024
Approval date [1] 315543 0
Ethics approval number [1] 315543 0

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

Contacts
Principal investigator
Name 135030 0
A/Prof Leanne Sakzewski
Address 135030 0
Centre for Children's Health Research, 62 Graham Street, South Brisbane, QLD 4030
Country 135030 0
Australia
Phone 135030 0
+61 07 30697396
Fax 135030 0
Email 135030 0
[email protected]
Contact person for public queries
Name 135031 0
Leanne Sakzewski
Address 135031 0
Centre for Children's Health Research, 62 Graham Street, South Brisbane, QLD 4030
Country 135031 0
Australia
Phone 135031 0
+61 07 30697396
Fax 135031 0
Email 135031 0
[email protected]
Contact person for scientific queries
Name 135032 0
Leanne Sakzewski
Address 135032 0
Centre for Children's Health Research, 62 Graham Street, South Brisbane, QLD 4030
Country 135032 0
Australia
Phone 135032 0
+61 07 30697396
Fax 135032 0
Email 135032 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a children with disabilities study with the participants being the parents of the child, so the information/data will not be shared about the children.


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.