Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000042549
Ethics application status
Approved
Date submitted
23/11/2023
Date registered
18/01/2024
Date last updated
2/06/2024
Date data sharing statement initially provided
18/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Active Start Active Future: a randomised control trial of an early behaviour-change intervention targeting physical activity levels in young children with cerebral palsy
Scientific title
Active Start Active Future: a randomised control trial of an early behaviour-change intervention targeting physical activity participation and sedentary behaviour in young children with cerebral palsy
Secondary ID [1] 311016 0
None
Universal Trial Number (UTN)
U1111-1300-7421
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 332129 0
physical inactivity 332130 0
sedentary behaviour 332131 0
Condition category
Condition code
Neurological 328855 328855 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 328856 328856 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active Start Active Future is a participation focused physical activity (PA) intervention that promotes being active through behaviour change strategies. The intervention moves away from a more traditional therapy hands on approach to an approach driven by the child's and parents preferences to participate. The strategies identify barriers to being active and focuses on facilitators to help the child and their family increase participation in their preferred physical activities. We aim to recruit 40 young children with cerebral palsy (CP) (20 immediate intervention and 20 wait list). All wait list children will receive the intervention at 6 months.

Children with CP who mobilise at Gross Motor Functional Classification System Level II - V (use a rail for stairs and less balance on uneven ground to full support needed) will be invited to participate. All children recruited will receive one-hour weekly sessions for 8 weeks. Parents/main carer will also be participants, with collection of their physical activity and sedentary physical activity levels via questionnaire and a qualitative exploration of their physical activity views and motives. Sessions will be delivered in location of choice: family home, pre/school or community. All sessions will be conducted by a qualified physiotherapist, and the child and at least one parent/carer will attend each session. Treatment notes will be written after each session (record of attendance and session content) and any correspondence between sessions such as planning, ordering of equipment, and sharing of information will be recorded on a secure RedCap database. Usual care diaries will also be kept by families and recorded on RedCap also..

Active Start Active Future will share a similar theoretical framework and delivery mode with participation-focused therapy, Participate-CP for older children with CP (8-12 years) and feasibility study in 2020 for the younger age group. The design includes motor learning and targeted training of skills to assist with physical performance goal attainment. The framework supports participants’ basic psychological needs for autonomy, competence and relatedness according to Self-Determination Theory.

Active Start Active Future will facilitate more intrinsic types of motivation by supporting children to achieve 2-3 self-identified PA behaviour goals - encouraging increased participation in PA and increasing skill development of one physical goal for the child. Each parent/carer will also set 2 participation goals that focus on their ability to support their child’s behaviour change. For example, a child's participation goal may be to attend swimming 1x/week and to enjoy swimming. The parents goal may be to make time to attend swimming and support their child in the pool. The physical goals may be for the child to float on their back for 3 seconds.

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).

Children will be assessed at baseline T1, end of intervention T2 and at follow up T3 (6 months following baseline) to determine any sustained changes as a result of the intervention. The wait list group will begin the intervention at T3 and complete the 8 weeks at T4. Children are able to participate in any of the regular therapies and physical activities.
Intervention code [1] 327455 0
Rehabilitation
Intervention code [2] 327456 0
Behaviour
Intervention code [3] 327459 0
Lifestyle
Comparator / control treatment
In total, 40 young children with CP will be recruited. Children will be block randomised to either receive the Active Start Active Future intervention immediately (n=20), or waitlist usual care (n=20). The waitlist group will go on to receive Active Start Active Future intervention after the 26 week retention time point (T3).
Control group
Active

Outcomes
Primary outcome [1] 336651 0
Participation attendance goals (frequency and diversity) using the Canadian Occupational Performance Measure COPM
Timepoint [1] 336651 0
T1 Baseline all participants, T2 8 weeks at end of intervention for intervention group and wait list as waiting, T3 6 months follow up post baseline for intervention group and wait list group to begin intervention, and T4 post intervention for wait list group (34 weeks post-baseline)
Primary outcome [2] 336943 0
Participation involvement goals using the Canadian Occupational Performance Measure COPM
Timepoint [2] 336943 0
T1 Baseline all participants, T2 8 weeks at end of intervention for intervention group and wait list as waiting, T3 6 months follow up post baseline for intervention group and wait list group to begin intervention, and T4 post intervention for wait list group (34 weeks post-baseline)
Primary outcome [3] 336944 0
Physical activity goals using the Canadian Occupational Performance Measure COPM
Timepoint [3] 336944 0
T1 Baseline all participants, T2 8 weeks at end of intervention for intervention group and wait list as waiting, T3 6 months follow up post baseline for intervention group and wait list group to begin intervention, and T4 post intervention for wait list group (34 weeks post-baseline)
Secondary outcome [1] 429181 0
Daily time spent in Sedentary Physical Activity
Timepoint [1] 429181 0
T1 Baseline all participants, T2 8 weeks at end of intervention for intervention group and wait list as waiting, T3 6 months follow up post baseline for intervention group and wait list group to begin intervention, and T4 post intervention for wait list group (34 weeks post-baseline)
Secondary outcome [2] 429182 0
Gross Motor Function Measure-66-IS
Timepoint [2] 429182 0
T1 Baseline all participants, T2 8 weeks at end of intervention for intervention group and wait list as waiting, T3 6 months follow up post baseline for intervention group and wait list group to begin intervention, and T4 post intervention for wait list group (34 weeks post-baseline)
Secondary outcome [3] 429183 0
Cerebral Palsy Quality of Life Questionnaire for Children, Parent-proxy Version (CP QOL)
Timepoint [3] 429183 0
T1 Baseline all participants, T2 8 weeks at end of intervention for intervention group and wait list as waiting, T3 6 months follow up post baseline for intervention group and wait list group to begin intervention, and T4 post intervention for wait list group (34 weeks post-baseline)
Secondary outcome [4] 429184 0
Barriers to Participation in Physical Activities Questionnaire (BPPA-Q)
Timepoint [4] 429184 0
T1 Baseline all participants, T2 8 weeks at end of intervention for intervention group and wait list as waiting, T3 6 months follow up post baseline for intervention group and wait list group to begin intervention, and T4 post intervention for wait list group (34 weeks post-baseline)
Secondary outcome [5] 429185 0
Belief in Goal Self-Competence Scale
Timepoint [5] 429185 0
T1 Baseline all participants, T2 8 weeks at end of intervention for intervention group and wait list as waiting, T3 6 months follow up post baseline for intervention group and wait list group to begin intervention, and T4 post intervention for wait list group (34 weeks post-baseline)
Secondary outcome [6] 429186 0
The Active Australia Survey
Timepoint [6] 429186 0
Parent/main carer completes at T1 Baseline, T2 8 weeks at end of intervention for intervention group and wait list as waiting, T3 6 months follow up post baseline for intervention group and wait list group to begin intervention, and T4 post intervention for wait list group (34 weeks post-baseline)
Secondary outcome [7] 429187 0
Acceptability Questionnaire
Timepoint [7] 429187 0
T2 8 weeks at end of intervention for parent/carer of intervention group and T4 post intervention for parent/carer of wait list group (34 weeks post baseline)
Secondary outcome [8] 429188 0
Qualitative Semi Structured Interviews
Timepoint [8] 429188 0
T2 8 weeks at end of intervention and T3 6 months follow up post baseline. Only intervention group not waitlist group
Secondary outcome [9] 429626 0
Past-day Adults’ Sedentary Time (PAST) Questionnaire
Timepoint [9] 429626 0
Parent/main carer completes at T1 Baseline, T2 8 weeks at end of intervention for intervention group and wait list as waiting, T3 6 months follow up post baseline for intervention group and wait list group to begin intervention, and T4 post intervention for wait list group (34 weeks post-baseline)
Secondary outcome [10] 429627 0
Health Promoting Activities Scale
Timepoint [10] 429627 0
Parent/main carer completes at T1 Baseline, T2 8 weeks at end of intervention for intervention group and wait list as waiting, T3 6 months follow up post baseline for intervention group and wait list group to begin intervention, and T4 post intervention for wait list group (34 weeks post-baseline)
Secondary outcome [11] 430856 0
Daily time spent in Moderate to Vigorous Physical Activity
Timepoint [11] 430856 0
T1 Baseline all participants, T2 8 weeks at end of intervention for intervention group and wait list as waiting, T3 6 months follow up post baseline for intervention group and wait list group to begin intervention, and T4 post intervention for wait list group (34 weeks post-baseline)

Eligibility
Key inclusion criteria
Children will be included
(a) who have been diagnosed with CP functioning at GMFCS levels II-V,
(b) are between 3.00-7.99 years,
(c) have at least one primary caregiver that can also participate, and
(d) have a primary residential address within 100km of South Brisbane, QLD,
(e) if this is the sole therapy intervention study they are enrolled in.

Adults will be included who
(a) are primary parent/carer of the child enrolled,
Additional adults who are significantly involved with the child’s physical activity participation may be enrolled for the qualitative interviews only if they
(b) support the intervention in the community (community therapists, community members e.g., coaches), or
(c) support the intervention at pre school, kindy, school (school therapists, education and child care staff).
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children will be excluded if the child:
(a) has orthopaedic and/or neurological surgery within 6 months prior to baseline or planned during the study period,
(b) has uncontrolled epilepsy and/or medical fragility
(c) is already participating in a therapy intervention study

No maximum age for adults. Adults can be healthy volunteers

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)
The allocation sequence will be generated by a biostatistician not involved in the study. Allocation will not be revealed until all baseline assessments have been completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated random number sequence with concealed allocation will be used for division/allocation using REDCap®.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A total of 40 participants; 20 in each group, will be recruited to the program. This sample size will give us 80% power to detect a 2-point difference (clinically meaningful difference) on the primary outcome, The Canadian Occupational Performance Measure (COPM) assuming a standard deviation of 2 with a=0.05 and buffering for 10% attrition. Children will be randomised using a block design and stratified by GMFCS levels (II-II and IV-V).
Qualitiative interview transcripts will be thematically analysed with a content analysis approach using NVivo. A qualitative descriptive approach will be used to explore the experiences of the parents/carers. No statistics will be conducted and we will aim for over 50 % of the the parent/carers to be interviewed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/02/2024
Actual
10/04/2024
Date of last participant enrolment
Anticipated
4/11/2024
Actual
Date of last data collection
Anticipated
5/02/2026
Actual
Sample size
Target
40
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 315279 0
University
Name [1] 315279 0
The University of Queensland
Country [1] 315279 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland, St Lucia, Brisbane, QLD 4072
Country
Australia
Secondary sponsor category [1] 317317 0
Hospital
Name [1] 317317 0
Queensland Children's Hospital
Address [1] 317317 0
Queensland Children's Hospital, 501 Stanley Street, South Brisbane QLD 4101
Country [1] 317317 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314198 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 314198 0
Ethics committee country [1] 314198 0
Australia
Date submitted for ethics approval [1] 314198 0
15/08/2023
Approval date [1] 314198 0
31/10/2023
Ethics approval number [1] 314198 0
HREC/23/QCHQ/100850

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

Contacts
Principal investigator
Name 130762 0
Dr Gaela Kilgour
Address 130762 0
Child Health Research Centre, 62 Graham Street, South Brisbane, QLD 4101
Country 130762 0
Australia
Phone 130762 0
+61730697338
Fax 130762 0
Email 130762 0
[email protected]
Contact person for public queries
Name 130763 0
Gaela Kilgour
Address 130763 0
Child Health Research Centre, 62 Graham Street, South Brisbane, QLD 4101
Country 130763 0
Australia
Phone 130763 0
+61730697338
Fax 130763 0
Email 130763 0
[email protected]
Contact person for scientific queries
Name 130764 0
Gaela Kilgour
Address 130764 0
Child Health Research Centre, 62 Graham Street, South Brisbane, QLD 4101
Country 130764 0
Australia
Phone 130764 0
+61730697338
Fax 130764 0
Email 130764 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


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.