Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000519853
Ethics application status
Approved
Date submitted
17/03/2021
Date registered
4/05/2021
Date last updated
2/05/2023
Date data sharing statement initially provided
4/05/2021
Date results provided
2/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
MANA: Comparing Occupational Performance Coaching with usual care to Nurture Meaning, Agency and Autonomy in children with neurodisability and their families.
Scientific title
MANA: Meaning, Agency & Nurturing Autonomy. A single blind, 2-arm parallel group cluster randomized controlled trial to study the effect on social participation, health and wellbeing of Occupational Performance Coaching compared to usual care for children with neuro-developmental disability and their caregivers.
Secondary ID [1] 303721 0
Health Research Council (sponsor) reference: 19/617
Universal Trial Number (UTN)
U1111-1252-5272
Trial acronym
MANA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neurodisability 321145 0
Condition category
Condition code
Neurological 318950 318950 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. NAME
Occupational Performance Coaching (OPC)

2. WHY
OPC draws on dynamic systems perspectives of enablement, ecological perspectives of learning and behaviour change, and humanist and behaviour change principles to enhance client engagement in rehabilitation toward achieving personally valued occupational/participation goals.

3. WHAT MATERIALS
The therapist uses no specialised equipment or materials. No standardised assessments or other assessment of impairments are used. No hands-on or directive (e.g., therapist arranging environment) methods are used with either the client or their dependent unless requested by the client in the context of context of trialling ideas within a coaching exchange.

4. WHAT PROCEDURES
OPC commences with questioning to identify clients’ desired future state goals. Goals may not be directly related to health conditions or impairments. Goals are expressed at the level of observable action, comprising statement of an activity in a specific context which reflects personally meaningful change. Therapists consciously express empathy and listen mindfully to enhance the conditions for client trust in the therapist.

Therapists engage clients in a reflective discourse to explore potential actions that could lead to goal progress. Therapist questioning positions clients as knowledge holders and decision makers, thus as agents of change. Therapists may provide specialist knowledge to clients only if clients give permission for this, if a knowledge gap is apparent after exploration of what clients already know. Goal progress is evaluated regularly with clients as the evaluator of change.

5. WHO PROVIDED
OPC will be applied by physiotherapists, occupational therapists and speech and language therapists with a minimum of 24 hours training in OPC, and with a minimum of 6 months experience on working with children with neurodisability.

6. HOW DELIVERED
OPC will be delivered 1:1 through in person, telephone/video conference delivery.

7. WHERE
OPC is delivered in a private space such as clients’ home, workplace or clinic setting or via phone or video conferencing.

8. WHEN and HOW MUCH
OPC will commence when families are consented to the study and meet study criteria, including having a concern or goal for themselves or their child with neurodisability.
OPC frequency is typically weekly or fortnightly but is at clients’ discretion.
OPC sessions typically take 45-60 minutes but can range from 20 to 90 minutes.
Total number of sessions in research studies ranges from one to 10 sessions. Sessions cease at participant determined goal achievement within a maximum of 12 weeks.

9. TAILORING
OPC questioning style is tailored to match clients’ language and cognitive ability and literacy level. For clients with significant cognitive impairment OPC discourse is kept short and interspersed with active practice of goal related activities. Within New Zealand, tailoring of Maori involves inclusion of whakawhanangatanga as per the Hui Process (Lacey, 2011).

10. MODIFICATIONS (During a study in response to study events)
None planned.

11. HOW WELL (Planned)
Quality of OPC delivery is assessed using the OPC fidelity measure (OPC-FM). Fidelity is assessed by therapists trained in OPC to an advanced level. Fidelity scores of >80% are estimated as required to elicit the desired client response. The OPC casenote audit tool is also used as a proxy fidelity indicator.

12. HOW WELL (Actual)
Fidelity scores of audio recorded delivered intervention will be reported with study findings.
Intervention code [1] 320029 0
Rehabilitation
Intervention code [2] 320391 0
Treatment: Other
Intervention code [3] 320392 0
Behaviour
Comparator / control treatment
Usual Care is the name given to the comparison intervention for this study. Usual Care refers to care as it would typically be given to study participants, should this study not be occurring. Usual Care is selected as the comparison intervention because it would be unethical to offer a sham intervention to participants who are patients within the health system. Usual Care as the comparison allows the study to be undertaken with the least possible disruption to the health delivery systems, thus enabling and authentic evaluation of the effects of OPC. Usual care is known to be highly variable in New Zealand, however tends to be therapist directed and impairment focused (in comparison to OPC which is client-led and participation focused). Usual care will be monitored using the same measures as the OPC intervention group (casenote audit, audio recording of sessions rated against OPC Fidelity Measure completed by researchers and Session Rating Scale completed by caregivers. Thus, Usual Care can not accurately be described apriori at the level of detail of the TIDieR checklist, given its known variability. However, TIDieR components could be described based on the monitoring data about Usual Care in the description of study findings.
Control group
Active

Outcomes
Primary outcome [1] 326876 0
Children’s participation in personally valued life situations, as measured by > 1 point improvement on individualised goals established by caregivers on the Canadian Occupational Performance Measure.
Timepoint [1] 326876 0
All participants in the study will complete the primary outcome at the same (revised) time of 16 weeks from first treatment.
Secondary outcome [1] 392941 0
Children’s functional ability measured by the Pediatric Evaluation of Disability Inventory
Timepoint [1] 392941 0
All participants in the study will complete the secondary outcome at the same (revised) time of 16 weeks from first treatment.
Secondary outcome [2] 392942 0
Caregiver mental health measured by the Depression Anxiety Stress Scale
Timepoint [2] 392942 0
All participants in the study will complete the secondary outcome at the same (revised) time of 16 weeks from first treatment.
Secondary outcome [3] 392943 0
child reported quality of life as measured by the Kidscreen10
Timepoint [3] 392943 0
All participants in the study will complete the secondary outcome at the same (revised) time of 16 weeks from first treatment.
Secondary outcome [4] 394635 0
Maori caregiver experience of receiving OPC intervention, gathered by audio recorded interview, and analysed using thematic analysis, will occur for Maori caregivers only. There had been 18 recruited participants at the time of the change.
Timepoint [4] 394635 0
Maori participants in the study will complete post intervention interviews at the same (revised) time of 16 weeks from first treatment.

Eligibility
Key inclusion criteria
Children: aged 2 to 18 years (inclusive), and, has a primary diagnosis of neurodisability (ND) for which the caregiver has sought rehabilitation of three or more sessions (treatments).

Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Caregivers lack sufficient English literacy to complete an interview or the written outcome measures.
• The child has been referred solely for adaptive equipment (e.g., wheelchairs).
• The service offers group-only service only to the child or caregiver.
• The child or caregiver plan to start an alternative rehabilitation intervention during the study period (e.g., Botox injections; Constraint Induced Movement Therapy, dorsal basal risotomy, Applied Behaviour Analysis).
• The caregiver-child (or the same child with an alternative caregiver) is already enrolled in the study with another therapist.

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)
Central randomisation by computer via REDcap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (REDcap)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Clustering at the level of the therapist.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total sample size of 46 child-caregivers would provide 90% power at a two-sided alpha of 0.05 to detect an effect size of 1 SD or greater using a simple t-test. For an ANCOVA analysis of a cluster RCT, this sample size must be multiplied by a design effect to account for the correlation structure of the data (Rutterford, Copas, & Eldridge, 2015). At six child-caregivers per therapist, our best estimate of the design effect is 1.2 (intracluster correlation = 0.1 (Tokolahi, Vandal, Kersten, Pearson, & Hocking, 2018), cluster autocorrelation = 0.5, subject autocorrelation = 0).

The final sample size of 84 child-caregiver dyads (14 therapists), also allows for 20% treatment contamination in the control group and 15% lost-to-follow-up. Maori simulation analyses suggest that recruiting 50% Maori participants would increase the power to detect a differential treatment effect of 2-points or greater on the COPM scale (minimal clinical difference on primary outcome measure) from ~ 50% to ~ 80%. This would enable an adequately powered subgroup analysis by ethnicity. Thus, for Maori a sample size of three Maori and three non-Maori cases per therapist will be sought. Specific procedures for this are outlined in the recruitment section.

For post-intervention exit interviews (Appendix I), a sample size of 10 (all Maori) will be sought for caregiver interviews. High sector interest in this study (Graham et al.) and OPC training demand suggests sample size targets are achievable.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2021
Actual
1/06/2021
Date of last participant enrolment
Anticipated
1/02/2023
Actual
16/03/2023
Date of last data collection
Anticipated
31/08/2023
Actual
Sample size
Target
84
Accrual to date
Final
98
Recruitment outside Australia
Country [1] 23542 0
New Zealand
State/province [1] 23542 0

Funding & Sponsors
Funding source category [1] 308130 0
Government body
Name [1] 308130 0
Health Research Council (NZ)
Country [1] 308130 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
34 Gloucester St, Central City, Christchurch, 8013, New Zealand
Country
New Zealand
Secondary sponsor category [1] 308891 0
None
Name [1] 308891 0
Address [1] 308891 0
Country [1] 308891 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308117 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 308117 0
Ethics committee country [1] 308117 0
New Zealand
Date submitted for ethics approval [1] 308117 0
23/07/2020
Approval date [1] 308117 0
20/08/2020
Ethics approval number [1] 308117 0
20/STH/93

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

Contacts
Principal investigator
Name 109594 0
Dr Fiona Graham
Address 109594 0
University of Otago, 34 Gloucester St, City Central, Christchurch, 8013
Country 109594 0
New Zealand
Phone 109594 0
+6433643620
Fax 109594 0
Email 109594 0
fi.graham@otago.ac.nz
Contact person for public queries
Name 109595 0
Fiona Graham
Address 109595 0
University of Otago, 34 Gloucester St, City Central, Christchurch, 8013
Country 109595 0
New Zealand
Phone 109595 0
+6433643620
Fax 109595 0
Email 109595 0
fi.graham@otago.ac.nz
Contact person for scientific queries
Name 109596 0
Fiona Graham
Address 109596 0
University of Otago, 34 Gloucester St, City Central, Christchurch, 8013
Country 109596 0
New Zealand
Phone 109596 0
+6433643620
Fax 109596 0
Email 109596 0
fi.graham@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No ethical approval is in place for sharing of individual participant data beyond the reserach team.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11038Study protocol  fi.graham@otago.ac.nz Peer reviewed publication of study protocol
11039Statistical analysis plan  fi.graham@otago.ac.nz Peer reviewed publication of study protocol
11040Informed consent form  fi.graham@otago.ac.nz Peer reviewed publication of study protocol
11041Clinical study report  fi.graham@otago.ac.nz
11042Ethical approval  fi.graham@otago.ac.nz Peer reviewed publication of study protocol
11043Analytic code  jonathan.williman@otago.ac.nz On request to fi.graham@otago.ac.nz



Results publications and other study-related documents

Documents added manually
Current Study Results
Documents were uploaded by study researchers but have since been removed.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3891Basic resultsNo 381634-(Uploaded-12-04-2024-14-14-53)-Basic results summary.docx
4163Plain language summaryNo Findings indicated no difference between OPC and u... [More Details]

Documents added automatically
No additional documents have been identified.