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Trial registered on ANZCTR


Registration number
ACTRN12618000206224
Ethics application status
Approved
Date submitted
24/01/2018
Date registered
9/02/2018
Date last updated
20/08/2019
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
PARTICIPATE-CP: Optimising participation in physically active leisure for children with Cerebral Palsy
Scientific title
The effect of a participation-focused therapy (PARTICIPATE-CP) on participation in physically active leisure for children with Cerebral Palsy: A randomised controlled trial
Secondary ID [1] 293778 0
None
Universal Trial Number (UTN)
Trial acronym
PARTICIPATE-CP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 306174 0
Condition category
Condition code
Neurological 305287 305287 0 0
Other neurological disorders
Musculoskeletal 305466 305466 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 305584 305584 0 0
Occupational therapy
Physical Medicine / Rehabilitation 305585 305585 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participate-CP is a targeted intervention underpinned by Self Determination Theory and using communication techniques of motivational interviewing. It is individualised and specifically tailored to the participation related goals and preferences of children and their family. This is a major paradigm shift in therapy approaches for children with CP. Participate-CP represents a departure from existing interventions tested in RCTs as it does not use a standardized intervention (e.g. standardized, non-individualized strength training with definable characteristics such as repetitions and exercise techniques), found to be ineffective to increase physical activity participation in this population. Participate-CP is a model of pragmatic participation-focused therapy utilising a toolbox of evidence-based strategies. A key feature of Participate-CP is the use of clinical reasoning based on key factors, which likely differ substantially between participating parent-child dyads. These factors include the: (i) choice of participation goals; (ii) identification of barriers and facilitators to participation in physically active leisure; (iii) acknowledgement of child-family-environment-activity-participation interactions and; (iv) stage of parent-child dyad physical activity behaviour change. Essential elements of Participate-CP include:

1. Goal directed, individualised and family-centred:
Two to three participation goals (e.g. horseback riding once per week in the community) are first identified by the child and parent. The therapist then explores with the child and family the potential barriers/limiting factors and facilitators to the participation goals (e.g. equipment requirements, community attitudes, child factors).

2. Ecological:
The intervention is delivered individually in the child’s home, school, community environment as relevant to each participation goal by a physiotherapist, occupational therapist, or exercise scientist, trained in the use of Motivational Interviewing and coaching.

3. Multifaceted intervention strategies:
Strategies are targeted to the unique and modifiable barriers to participation for each child will include a combination of: (a) Motivational interviewing strategies used earlier and to a greater extent with dyads who have not yet started thinking about participating in more physical activity; (b) Equipment prescription or loan where access to appropriate equipment is an identified barrier to participation; (c) Cognitive-orientation approaches to motor learning and skill performance used with participants with high motivation to attain a specific skill, and where the lack of skill is a barrier to internally motivated, self-determined participation; (d) Solution-focused problem solving where behavioural strategies such as action planning, scheduling and monitoring (may be appropriate solutions for beginning and maintaining participation or overcoming environmental barriers).
Therapists will video-record all intervention sessions for central monitoring of content and fidelity across sites.

Intervention is delivered as weekly one hour sessions over 12 weeks. The first and last weeks involve goal setting and measurement. Children will continue to receive usual care throughout the trial period. Usual care will be highly valuable both within and across participating sites. Caregivers will complete a usual care diary that records the number of hours per week their child accessed (rounded up to the nearest hours) of each of the following therapies:
• Physiotherapy
• Occupational Therapy
• Speech/Language Therapy
• Exercise Physiology/ Exercise Therapy
• Psychology/ Counselling

Caregivers will be asked to report any episodes of Botulinum Toxin-A injections (site/s, date/s), and casting/splinting for hypertonicity/contracture management until follow-up assessment (intervention group) or the end of the intervention (wait-list- group). Usual care will be compared between intervention and wait-list participants,
Intervention code [1] 300032 0
Rehabilitation
Intervention code [2] 300175 0
Treatment: Other
Comparator / control treatment
Both the Participate-CP and waitlist group receive usual care throughout the trial period. Usual care will be highly variable both within and across participating sites. Caregivers will complete a usual care diary that records the number of hours per week their child accessed (rounded up to the nearest hour) of each of the following therapies:
• Physiotherapy
• Occupational Therapy
• Speech/Language Therapy
• Exercise Physiology/ Exercise Therapy
• Psychology/ Counselling

Caregivers will also be asked to report any episodes of Botulinum Toxin-A injections (site/s, date/s) and casting/splinting for hypertonicity/contracture management (site/s, date/s). Participants will complete the diary from the first assessment until follow-up assessment (intervention group) or the end of the intervention (wait-list group). Usual care will be compared between intervention and wait-list participants.

Waitlist: 26 weeks
Control group
Active

Outcomes
Primary outcome [1] 304444 0
Canadian Occupational Performance Measure (COPM) performance with physically active leisure participation goals

The COPM will be used to measure performance of individually defined physically active leisure participation goals. Test retest reliability is high (ICC 0.76-0.89) and the COPM is responsive to change. To ensure that goals reflect the participation construct and not the activity domain of the ICF, the Family of Participation-Related Constructs will be employed to frame goals in terms of frequency of attendance and/or involvement. Two to three COPM goals will be set at baseline and scored at 12 weeks. A further two to three goals will be set at 12 weeks and scored at 26 weeks if the original goal/s have been achieved to the satisfaction of the child and caregiver. New goals can also be set within the intervention period (0-12 weeks) if original goals are achieved to the satisfaction of the child and their caregiver.
Timepoint [1] 304444 0
Immediately post completion of the first session of the 12 week intervention (week 12, primary timepoint) and 26 weeks post-completion of the first intervention session.
Primary outcome [2] 304445 0
Daily time spent in Moderate to Vigorous Physical Activity

ActiGraph GT3X+ will be worn on the hip for seven consecutive days. Activity counts will be transformed via the GMFCS-specific cut-points developed by CIF to time spent in sedentary behaviour, light and MVPA. These cut-points were shown to substantially reduce misclassification error among youth with more severe motor impairments; and provided more accurate assessments of physical activity intensity than previously published validation using cut-points for children and adolescents with CP. A wear time of seven days is required to achieve maximum validity in this population. Caregivers complete a logbook to record the child’s activity and position throughout each day of wear to perform validation of the data if required. Children will be offered a standard elastic belt for wearing the device on the waist and a neoprene cover if required for comfort.
Timepoint [2] 304445 0
Immediately post completion of the first session of the 12 weeks intervention and 26 weeks post-completion of the first intervention session.
Primary timepoint is at 12 weeks.
Primary outcome [3] 304609 0
Canadian Occupational Performance Measure (COPM) satisfaction with physically active leisure participation goals

The COPM will be used to measure satisfaction with individually defined physically active leisure participation goals. Test re-retest reliability is high (ICC 0.76-0.89) and the COPM is responsive to change. To ensure that goals reflect the participation construct and not the activity domain of the ICF, the Family of Participation-Related Constructs will be employed to frame goals in terms of frequency of attendance and/or involvement. Two to three COPM goals will be set at baseline and scored at 12 weeks. A further two to three goals will be set at 12 weeks and scored at 26 weeks if the original goal/s have been achieved to the satisfaction of the child and caregiver. New goals can also be set within the intervention period (0-12 weeks) if original goals are achieved to the satisfaction of the child and their caregiver.
Timepoint [3] 304609 0
Immediately post completion of the first session of the 12 weeks intervention and 26 weeks post-completion of the first intervention session.
Primary timepoint is at 12 weeks.
Secondary outcome [1] 341954 0
Goal attainment measured using Goal attainment Scaling (GAS) which looks at frequecy, intensity, diversity, capacity and/or independence of overarching participation goal

Goal Attainment Scaling (GAS) is an objective method of quantifying goal attainment. Goals are scored on a likert-type scale from -2 (representing no positive change at all from baseline / regression), -1 (a little less change than expected), 0 (attainment of goal at the expected level), +1 (a little more change than expected), to +2 (attainment of goal at much more than the expected level). Goals will be personally important to the individual (rather than standardized) with the distance between each increment representing a relatively equal amount of effort or improvement to achieve. Each goal will describe an element of participation, linked to the participant’s primary COPM goal, such as frequency, intensity, diversity, or assistance required. Goals will be set collaboratively mid-intervention (rather than at the same time at COPM goals in the first session) as some change in goal content is expected due to the iterative nature of the process. As goal-setting forms an integral part of the intervention, the wait-list control group will not set GAS goals until they undertake their own intervention period and GAS scores will be analysed as paired samples (within groups). A summary score will be calculated into an aggregate T-score.
Timepoint [1] 341954 0
Immediately post completion of the first session of the 12 week intervention and 26 weeks post-completion of the first intervention session.
Secondary outcome [2] 341955 0
Community participation frequency (Participation and Environment Questionnaire (PEM-CY))

Participation and Environment Questionnaire (PEM-CY) is a parent completed questionnaire with good test-retest reliability and internal consistency. Summary scores for participation frequency will be evaluated.
Timepoint [2] 341955 0
Immediately post completion of the first session of the 12 week intervention and 26 weeks post-completion of the first intervention session.
Secondary outcome [3] 341956 0
Contextual barriers to participation

Barriers to Participation in Physical Activities Questionnaire (BPPA-Q) is a questionnaire based on the Theoretical Domains Framework structure (TDF) and developed by the authors. Questionnaires based on TDF have validity and reliability to detect the presence and quantity of barriers and facilitators to behaviour change, and allows categorization of those barriers and facilitators based on established theories of behaviour change. Similar questionnaires have shown responsiveness to interventions. Questionnaire responses can be used as evidence to support the selection of behaviour change strategies in an intervention, and to detect changes following implementation of such strategies.
Timepoint [3] 341956 0
Immediately post completion of the first session of the 12 week intervention and 26 weeks post-completion of the first intervention session.
Secondary outcome [4] 341957 0
Quality of life (Cerebral Palsy Quality of Life Questionnaire for Children, Child Version and Parent-proxy Version (CP-QOL Child; CP QOL))

Cerebral Palsy Quality of Life Questionnaire for Children, Child Version and Parent-proxy Version (CP-QOL Child; CP QOL) developed by CIC and co-authors. Due to potential discordance between child and parent reported quality of life, both perspectives will be sought. The CP QOL has good concurrent validity, internal consistency (a 0.80-0.90) and test-retest reliability.
Timepoint [4] 341957 0
Immediately post completion of the first session of the 12 week intervention and 26 weeks post-completion of the first intervention session.
Secondary outcome [5] 341958 0
Intrinsic motivation for physical activities (Motives for Physical Activities Measure (MPAM-R))

Motives for Physical Activities Measure (MPAM-R) is a child self-report measure that assesses intrinsic (i.e. interest/enjoyment, competence, social) vs. extrinsic (appearance, fitness) types of motivation for physical activities undertaken by the child. The MPAM-R has been shown to predict the amount of change in physical activity following an intervention.
Timepoint [5] 341958 0
Immediately post completion of the first session of the 12 week intervention and 26 weeks post-completion of the first intervention session.
Secondary outcome [6] 341959 0
Child perception of an autonomy-supportive climate for physical activities (Physical Activity Climate Questionnaire (PACQ))

Physical Activity Climate Questionnaire (PACQ) is filled in by a person (i.e. child) with reference to a specific leading individual (i.e. their caregiver) in respect of participation in physical activities. The questionnaire contains 15 items that assess the perceived ‘climate’ created by the caregiver with respect to the child’s participation in physical activity. Higher average scores represent a higher level of child-perceived parental autonomy support for physical activity participation.
Timepoint [6] 341959 0
Immediately post completion of the first session of the 12 week intervention and 26 weeks post-completion of the first intervention session.
Secondary outcome [7] 342535 0
Community involvement (Participation and Environment Questionnaire (PEM-CY))

Participation and Environment Questionnaire (PEM-CY) is a parent completed questionnaire with good test-retest reliability and internal consistency. Summary scores for community involvement will be evaluated.
Timepoint [7] 342535 0
Immediately post completion of the first session of the 12 week intervention and 26 weeks post-completion of the first intervention session.
Secondary outcome [8] 342536 0
Environmental supportiveness (Participation and Environment Questionnaire (PEM-CY))

Participation and Environment Questionnaire (PEM-CY) is a parent completed questionnaire with good test-retest reliability and internal consistency. Summary scores for environmental supportiveness will be evaluated.
Timepoint [8] 342536 0
Immediately post completion of the first session of the 12 week intervention and 26 weeks post-completion of the first intervention session.
Secondary outcome [9] 342572 0
Quality of Life (The Child Health Utility Index (CHU9))

The Child Health Utility Index (CHU9) is a paediatric health related quality of life measure for use in economic evaluation. The measure consists of nine questions. Children can self-report from seven years of age and parents can proxy report for their child. In this study, the CHU9 will be completed by the child's primary caregiver.

Timepoint [9] 342572 0
Immediately post completion of the first session of the 12 week intervention and 26 weeks post-completion of the first intervention session.

Eligibility
Key inclusion criteria
(a) aged 8-14 years
(b) confirmed diagnosis of CP from rehabilitation specialist;
(c) Gross Motor Function Classification (GMFCS) Levels I-IV;
(d) lives within 150km radius of trial sites
(e) at least one parent understands written and verbal English and can speak English (information and consent materials and questionnaires will not be available in languages other than English)
(f) there is a desire to work on goals around participating more often or being more involved physical activities
Minimum age
8 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) limited ability of child to communicate insight into preferred future (needs, wants, desires) in spoken English AND/OR through an interpreter or augmentative/alternative communication (i.e. Communication Function Classification System Levels IV-V);
(b) significant intellectual disability (IQ<50);
(c) uncontrolled epilepsy;
(d) severe asthma exacerbated by exercise, not controlled with medication under an asthma management plan;
(e) planned orthopaedic surgery 6 months prior to or throughout intervention/follow-up period
(f) was enrolled and previously received the intervention in the pilot study in South-East Queensland (2016-2017)

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)
An electronic system will determine allocation, completed by non-study personnel. Group allocation will be concealed to the treating therapist, research team, and the family until after all baseline measures except 7-day ActiGraph are completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
One central randomization schedule using computer-generated random numbers (in permuted blocks of four), to receive Participate-CP immediately or to waitlist standard care.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analyses will follow standard principles for RCTs using two-group comparisons on all participants on an intention-to-treat basis. Primary comparison at 12 weeks (T2 post) on COPM performance and satisfaction will be between treatment groups using linear regression with treatment group (Participate-CP/waitlist control) included as the main effect and stratification factors as co-variables. Effect estimates will be presented as mean difference and 95% confidence interval. Secondary analyses will use similar methods to compare outcomes between groups at 12 weeks for HPA level and sedentary behaviours, participation frequency, involvement and environmental supportiveness (PEM-CY) and self and parent-proxy reported quality of life (CPQOL-Child). In cases where interval data cannot be transformed appropriately for regression analyses, non-parametric methods (Mann-Whitney U) will be used for between-treatment comparisons. Recruitment bias will be assessed by comparing sociodemographic and clinical variables for consenters with non-consenters using t-tests (or Mann-Whitney U tests) for continuous variables and chi-squared tests for categorical variables. Possible differential attrition will be assessed by comparing baseline characteristics of drop-outs and continuing participants using t-tests (or Mann-Whitney U tests if appropriate) for continuous variables and chi-squared tests for categorical variables. Sensitivity analyses of all outcomes will be conducted using multiple imputation techniques, to investigate the effect of non-ignorable missing data during follow up.

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)
NSW,QLD,WA
Recruitment hospital [1] 9758 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [2] 9759 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [3] 9761 0
Cairns Base Hospital - Cairns
Recruitment hospital [4] 9864 0
Cerebral Palsy Alliance - Allambie Heights
Recruitment postcode(s) [1] 18536 0
4101 - South Brisbane
Recruitment postcode(s) [2] 18537 0
6008 - Subiaco
Recruitment postcode(s) [3] 18539 0
4870 - Cairns
Recruitment postcode(s) [4] 18649 0
2100 - Allambie Heights

Funding & Sponsors
Funding source category [1] 298396 0
Government body
Name [1] 298396 0
National Health and Medical Research Council
Address [1] 298396 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 298396 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 297523 0
None
Name [1] 297523 0
Address [1] 297523 0
Country [1] 297523 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299388 0
Children's Health Queensland Human Research Ethics Committee
Ethics committee address [1] 299388 0
Level 7, Centre for Children's Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street South Brisbane QLD 4101
Ethics committee country [1] 299388 0
Australia
Date submitted for ethics approval [1] 299388 0
18/12/2017
Approval date [1] 299388 0
20/12/2017
Ethics approval number [1] 299388 0
HREC/17/QRCH/283
Ethics committee name [2] 299389 0
The University of Queensland's Human Research Ethics Committee
Ethics committee address [2] 299389 0
Cumbrae-Stewart Building #72
The University of Queensland
St Lucia QLD 4072
Ethics committee country [2] 299389 0
Australia
Date submitted for ethics approval [2] 299389 0
09/01/2018
Approval date [2] 299389 0
12/01/2018
Ethics approval number [2] 299389 0
2018000019/HREC/17/QRCH/283

Summary
Brief summary
In Australia, 35,000 people are living with cerebral palsy (CP). People with CP have poorer health outcomes, are less active and have a 1.2 to 1.6 greater risk of chronic health conditions such as diabetes, hypertension and stroke compared with those without a disability. We have promising data about a new intervention called Participate-CP, which is a therapy that improves children’s participation in physical activity goals that are meaningful to them. In this trial for 100 children with CP, we will compare Participate-CP to Standard Care to see whether or not the intervention delivers additional benefits over Standard Care.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2358 2358 0 0
Attachments [2] 2359 2359 0 0
Attachments [3] 2360 2360 0 0
Attachments [4] 2361 2361 0 0
/AnzctrAttachments/374298-Participate_Parent Info Sheet_2.0_11122017.docx (Participant information/consent)
Attachments [5] 2362 2362 0 0
/AnzctrAttachments/374298-Participate_Child Info Sheet_2.0_11122017.docx (Participant information/consent)
Attachments [6] 2363 2363 0 0
/AnzctrAttachments/374298-Participate_Consent_1.0_20171115.docx (Participant information/consent)

Contacts
Principal investigator
Name 80250 0
Dr Leanne Sakzewski
Address 80250 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Level 6 Centre for Children's Health Research
62 Graham Street South Brisbane QLD 4101
Country 80250 0
Australia
Phone 80250 0
+61 7 3069 7345
Fax 80250 0
Email 80250 0
l.sakzewski1@uq.edu.au
Contact person for public queries
Name 80251 0
Dr Natalie Dos Santos
Address 80251 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Level 6 Centre for Children's Health Research
62 Graham Street South Brisbane QLD 4101
Country 80251 0
Australia
Phone 80251 0
+61 7 3069 7356
Fax 80251 0
Email 80251 0
n.dossantos@uq.edu.au
Contact person for scientific queries
Name 80252 0
Dr Leanne Sakzewski
Address 80252 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Level 6 Centre for Children's Health Research
62 Graham Street South Brisbane QLD 4101
Country 80252 0
Australia
Phone 80252 0
+61 7 3069 7345
Fax 80252 0
Email 80252 0
l.sakzewski1@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All information will be coded with a participant ID number and no individual participant data will be available to ensure participants' and their families confidentiality and privacy.
What supporting documents are/will be available?
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 4162 0
Informed consent form
Citation [1] 4162 0
Link [1] 4162 0
Email [1] 4162 0
Other [1] 4162 0
Type [2] 4163 0
Ethical approval
Citation [2] 4163 0
Link [2] 4163 0
Email [2] 4163 0
Other [2] 4163 0
Summary results
No Results