Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001615875
Ethics application status
Approved
Date submitted
26/10/2021
Date registered
26/11/2021
Date last updated
1/06/2024
Date data sharing statement initially provided
26/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Orientation to daily Occupational Performance Approach (CO-OP) for children on the autism spectrum
Scientific title
Evaluating the acceptability and efficacy of Cognitive Orientation to daily Occupational Performance Approach TM (CO-OP) therapy for children on the autism spectrum: a randomised controlled trial (RCT)
Secondary ID [1] 305523 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 323914 0
Condition category
Condition code
Mental Health 321429 321429 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Orientation to daily Occupational Performance ApproachTM (CO-OP) was developed to support motor skill development of children with motor difficulties. CO-OP is a highly individualised client-centred program based on participant goals and uses a performance-based, problem solving, approach that enables skill acquisition through a process of strategy use and guided discovery; this strategy allows for generalisation and transfer of skills to other tasks (Mandich & Polatajko, 2004; Missiuna, Mandich, Polatajko, & Malloy-Miller, 2001; Polatajko, Mandich, Miller, & Macnab, 2001; Polatajko, Mandich, Missiuna, et al., 2001).

The CO-OP program is a 10-week block, comprising the initial goal setting session (treatment and control groups, ~2 hours), eight weeks of one hour CO-OP sessions, and a final 10th session (~1 hour) to assess outcomes (treatment and control groups).

During the eight-week therapy component of the program, children will attend a one-hour session each week in which a global cognitive strategy (goal, plan, do, check) will be utilised to support their learning of their chosen goals (three goals will be worked on throughout the program). Session attendance will be recorded and clinical notes recorded about the session. The program has a focus on guided discovery, enabling principles (fun, promoting learning, working towards independence), and parent involvement. The program will be delivered by CO-OP trained research therapists and the CO-OP trained members of the occupational therapy team at CliniKids.

The intervention sessions will include a welcome for the child and parent/guardian, and a general check in with child and parent/guardian. Following the welcome, approximately 20 minutes will be spent on each of the three goals. For each goal, the child, with assistance from the attending parent, will summarise what they have worked on at home, review the CO-OP plan trialled at home, and carry out the task. The clinician will use guided discovery to observe and support the child to develop a new plan if required and discuss and review Goal-Plan-Do-Check. At the end of each goal, the child and clinician will complete the home practice sheet with ideas for activities to perform at home between the intervention sessions. Children will be asked to practice their goals around 3-4 times per week at home.
Intervention code [1] 321923 0
Behaviour
Comparator / control treatment
Participants in the waitlist control group will not receive any intervention by the trial therapists during the initial 10 week block before completing their follow-up assessment. Following this wait period, they will undertake CO-OP therapy and then complete a final assessment session.
Both groups can continue to access any clinical services that they would usually access.
Control group
Active

Outcomes
Primary outcome [1] 329215 0
Change in Canadian Occupational Performance Measure (COPM)
Timepoint [1] 329215 0
Baseline, Treatment endpoint (within approximately two weeks of completion of the 8 week treatment/control block), Waitlist control group treatment endpoint (waitlist group only: within approximately two weeks of completion of the 8 week CO-OP block)
Primary outcome [2] 329216 0
Change in Performance Quality Rating Scale (PQRS)
Timepoint [2] 329216 0
Baseline, Treatment endpoint (within approximately two weeks of completion of the 8 week treatment/control block), Waitlist control group treatment endpoint (waitlist group only: within approximately two weeks of completion of the 8 week CO-OP block)
Secondary outcome [1] 401802 0
Change in Participation and Environment Measure for Children and Youth (PEM-CY)
Timepoint [1] 401802 0
Baseline, Treatment endpoint (within approximately two weeks of completion of the 8 week treatment/control block), Waitlist control group treatment endpoint (waitlist group only: within approximately two weeks of completion of the 8 week CO-OP block)
Secondary outcome [2] 403031 0
Participant and parent/caregiver rated Goal Attainment Scale
Timepoint [2] 403031 0
Baseline, Treatment endpoint (within approximately two weeks of completion of the 8 week treatment/control block), Waitlist control group treatment endpoint (waitlist group only: within approximately two weeks of completion of the 8 week CO-OP block)
Secondary outcome [3] 403032 0
Semi-structured interviews with parents to explore CO-OP acceptability.
Timepoint [3] 403032 0
Following CO-OP intervention completion.
Secondary outcome [4] 403033 0
Semi-structured interviews with therapists individually to explore CO-OP acceptability.
Timepoint [4] 403033 0
Following CO-OP intervention study completion.
Secondary outcome [5] 403034 0
Semi-structured interviews with participants where deemed appropriate by parents, to explore CO-OP acceptability.
Timepoint [5] 403034 0
Following CO-OP intervention completion.

Eligibility
Key inclusion criteria
Child : a) aged 5-10 years; b) has a diagnosis of autism spectrum disorder; c) has motor difficulties, defined as under or equal to the 16th percentile on the MABC-2; d) is able to set own goals as required by the CO-OP approach; e) family is, to the best of their knowledge, intending to remain in the Perth for the duration of the study.
Minimum age
5 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Intellectual disability that impacts ability to set own goals; b) Inability to develop cognitive strategies and plans to achieve goals; c) have previously undertaken any form of CO-OP therapy

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)
Allocation concealment will involve contacting the holder of the allocation schedule who is "off-site" after consent and eligibility (Session 1) has been completed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed with block randomisation using a variable block size (2 or 4), stratified by each of the clinician. Randomisation for each participant will occur offsite by a biostatistics team after completion of the intake assessment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is the first study to assess to effectiveness of CO-OP for children with autism; previously only case studies have been undertaken. As such, a sample size of 30 has been selected for this study to assess the acceptability and efficacy of the intervention approach.

For the primary outcome (COPM), performance and satisfaction scores from those in the treatment group will be compared to control/treatment as usual condition at equivalent post-treatment timepoints using a mixed ANOVA design.

For the primary outcome (PQRS), scores from those in the treatment group will be compared to control/treatment as usual condition at equivalent post-treatment timepoints using a mixed ANOVA design.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/02/2022
Actual
5/04/2022
Date of last participant enrolment
Anticipated
2/10/2023
Actual
11/09/2023
Date of last data collection
Anticipated
22/12/2023
Actual
6/12/2023
Sample size
Target
30
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 35526 0
6009 - Nedlands
Recruitment postcode(s) [2] 35527 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 309892 0
Government body
Name [1] 309892 0
Department of Education, Government of Western Australia
Country [1] 309892 0
Australia
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
Northern Entrance
Perth Children's Hospital
15 Hospital Ave
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 310920 0
None
Name [1] 310920 0
Address [1] 310920 0
Country [1] 310920 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309616 0
The University of Western Australia Human Research Ethics Committee (HREC)
Ethics committee address [1] 309616 0
Ethics committee country [1] 309616 0
Australia
Date submitted for ethics approval [1] 309616 0
12/10/2021
Approval date [1] 309616 0
13/12/2021
Ethics approval number [1] 309616 0
2021/ET000942

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

Contacts
Principal investigator
Name 114782 0
Dr Jess Reynolds
Address 114782 0
Northern Entrance
Perth Children's Hospital
15 Hospital Ave
Nedlands WA 6009
Country 114782 0
Australia
Phone 114782 0
+61 8 63191266
Fax 114782 0
Email 114782 0
[email protected]
Contact person for public queries
Name 114783 0
Jess Reynolds
Address 114783 0
Northern Entrance
Perth Children's Hospital
15 Hospital Ave
Nedlands WA 6009
Country 114783 0
Australia
Phone 114783 0
+61 8 63191266
Fax 114783 0
Email 114783 0
[email protected]
Contact person for scientific queries
Name 114784 0
Jess Reynolds
Address 114784 0
Northern Entrance
Perth Children's Hospital
15 Hospital Ave
Nedlands WA 6009
Country 114784 0
Australia
Phone 114784 0
+61 8 63191266
Fax 114784 0
Email 114784 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.