Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000438752
Ethics application status
Approved
Date submitted
10/02/2022
Date registered
18/03/2022
Date last updated
3/04/2024
Date data sharing statement initially provided
18/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Partnering together to explore the tailored implementation of the F-words for Child Development at an organizational level.
Scientific title
Partnering together to explore the tailored implementation of the F-words for Child Development at an organizational level: A pilot hybrid type III mixed-methods case evaluation.
Secondary ID [1] 306360 0
Nil known
Universal Trial Number (UTN)
U1111-1274-1886
Trial acronym
FWC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Developmental disabilities 325159 0
Condition category
Condition code
Physical Medicine / Rehabilitation 322564 322564 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The F-words for Child Development refer to concepts of Function, Family, Fitness, Fun, Friends and Future. The words can guide strength-based approaches to child development service delivery.

The study is informed by implementation research. It gathers information about the tailored strategies used to implement interventions guided by the F-words, contextual influences, and the effectiveness and impact of the strategies within a therapy service provider organization, and for children and their families receiving services with the organization.

The strategies used to implement the F-words intervention will be developed by an implementation team within the organization in consultation with a research assistant at a focus group and will reflect the group's knowledge of the organization, and client needs and contexts. The implementation team comprises directors, managers and other leaders within the organisation, and could also include therapists and parents who fulfill this role. The strategies developed by the implementation team will be incorporated into a blueprint/plan which is documented and provided to therapists who will adopt them when implementing services with children and their families. Development, documentation and sharing the implementation plan will take 2 weeks.

The F-words implementation intervention may include strategies such as the F-words Life-wheel approach for setting goals and guiding coaching, educational outreach and educational materials such as those found on the F-words knowledge hub, and involvement of local champions to promote the F-words intervention.

Services which will employ the strategies are delivered by New Zealand registered occupational therapists and physiotherapists. They will have engaged in a 1-day on-line training workshop about the F-words for Child Development delivered by experts within the organization. Services will commence 2 weeks after provision of the implementation plan using strategies from the plan to frame service delivery.

Services which incorporate the the F-words for Child Development implementation intervention are provided individually. The services respond to the individual service provision context, individual needs of children and their families and environmental constraints such as general health recommendations during the global pandemic. Services include interventions delivered through modalities such as face-to-face, internet resources (e.g. the F-words knowledge hub) or consultation via telephone or Zoom.

The frequency and duration of services framed by the F-words for Child Development respond to the individual needs of families and their children and there is no minimum or maximum frequency or duration of services.

Services guided by the F-words for Child Development implementation intervention are developed and delivered in the clinic setting, online, at the children's homes or schools, whichever is appropriate for the child and family needs and routines.

Services guided by the implementation plan are personalised according to interviews conducted with children and their families where their unique needs, strengths and resources are discussed. Interviews for personalisation of services will begin 4 weeks after implementation commences. Examples of services guided by the F-words implementation intervention may include coaching, education, or movement skills training.

The stage of developing and commencing implementation of the F-words intervention strategies is expected to take 1 month. Implementation of the services employing the strategies will take 11 months. Post implementation interviews with children and their families will occur 6 months after receiving services guided by the F-words strategies.

Adherence to and adoption of the implementation strategies will be tracked by the implementation team and therapists providing services using spreadsheets. Families' application of the F-words for Child Development will be ascertained during qualitative interview post intervention.
Intervention code [1] 322788 0
Rehabilitation
Intervention code [2] 322911 0
Lifestyle
Intervention code [3] 322912 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330383 0
Acceptability of Intervention Measure (AIM). Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, et al. (2017). The AIM is the tool that will be used to assess the Acceptability of the F-Words for Child Development implementation intervention from the perspectives of therapists.
Timepoint [1] 330383 0
Pre-study: Within 8 weeks of recruitment to study.
Post-study: 8-10 months after commencing implementation of intervention
Primary outcome [2] 330390 0
Intervention Appropriateness Measure (IAM). Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, et al. (2017). The IAM is the tool that will be used to assess the Appropriateness of the F-Words for Child Development implementation intervention from the perspectives of the organisation leaders.
Timepoint [2] 330390 0
Pre-study: Within 8 weeks of recruitment to study.
Post-study: 8-10 months after commencing implementation of intervention.
Primary outcome [3] 330391 0
Feasibility of Intervention Measure (FIM). Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, et al. (2017). The Feasibility of Intervention Measure is the tool that will be used to assess the feasibility of the F-words for Child Development implementation intervention from the perspectives of organisation leaders.
Timepoint [3] 330391 0
Pre-study: Within 8 weeks of recruitment to study.
Post-study: 8-10 months after commencing implementation of intervention
Secondary outcome [1] 406063 0
Measures of Processes of Care (MPOC-20). King S, King G, & Rosenbaum P. (2004). The MPOC-20 is the tool that will be used to assess the degree to which the F-Words for Child Development implementation intervention is family centred from the perspectives of parents.
Timepoint [1] 406063 0
Pre-study: Within 8 weeks of recruitment to study.
Post-study: 8-10 months after commencing implementation of intervention
Secondary outcome [2] 406064 0
.Measures of Processes of Care - Service Provider Version (MPOC-SP)JM, Rosenbaum PL, King SM, King GA. (2001).The MPOC-SP is the tool that will be used to assess the degree to which the F-Words for Child Development implementation intervention is family centred from the perspectives of therapists.
Timepoint [2] 406064 0
Pre-study: Within 8 weeks of recruitment to study.
Post-study: 8-10 months after commencing implementation of intervention
Secondary outcome [3] 406138 0
Qualitative interviews with parents will be used to gather information about empowerment, confidence, family-centred service, knowledge, attitude and use. The one-on-one interviews will be 30-60 minutes with a member of the research team. They will be conducted via Zoom or face-to-face as chosen by the participant.
Timepoint [3] 406138 0
Post-study: 8-10 months after commencing implementation of intervention
Secondary outcome [4] 406552 0
Qualitative interviews with children will be used to gather information about empowerment, family-centred service, knowledge, attitude and use. The one-on-one interviews will be 30-60 minutes with a member of the research team. They will be conducted via Zoom or face-to-face as chosen by the child participant and their parents. Children will have support from their parents as necessary during the interview.
Timepoint [4] 406552 0
Post-study: 8-10 months after commencing implementation of intervention
Secondary outcome [5] 407159 0
PRIMARY OUTCOME: Acceptability of Intervention Measure (AIM). Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, et al. (2017). The AIM is the tool that will be used to assess the Acceptability of the F-Words for Child Development implementation intervention from the perspectives of parents.
Timepoint [5] 407159 0
Pre-study: Within 8 weeks of recruitment to study. .
Post-study: 8-10 months after commencing implementation of intervention.
Secondary outcome [6] 407160 0
PRIMARY OUTCOME: Intervention Appropriateness Measure (IAM). Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, et al. (2017). The IAM is the tool that will be used to assess the Appropriateness of the F-Words for Child Development implementation intervention from the perspectives of the implementation team.
Timepoint [6] 407160 0
Pre-study: Within 8 weeks of recruitment to study.
Post-study: 8-10 months after commencing implementation of intervention.
Secondary outcome [7] 407161 0
PRIMARY OUTCOME: Intervention Appropriateness Measure (IAM). Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, et al. (2017). The IAM is the tool that will be used to assess the Appropriateness of the F-Words for Child Development implementation intervention from the perspectives of the therapists.
Timepoint [7] 407161 0
Pre-study: Within 8 weeks of recruitment to study.
Post-study: 8-10 months after commencing implementation of intervention.
Secondary outcome [8] 407162 0
PRIMARY OUTCOME: Intervention Appropriateness Measure (IAM). Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, et al. (2017). The IAM is the tool that will be used to assess the Appropriateness of the F-Words for Child Development implementation intervention from the perspectives of parents.
Timepoint [8] 407162 0
Pre-study: Within 8 weeks of recruitment to study.
Post-study: 8-10 months after commencing implementation of intervention.
Secondary outcome [9] 407163 0
PRIMARY OUTCOME: Feasibility of Intervention Measure (FIM). Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, et al. (2017). The Feasibility of Intervention Measure is the tool that will be used to assess the feasibility of the F-words for Child Development implementation intervention from the perspectives of the implementation team.
Timepoint [9] 407163 0
Pre-study: Within 8 weeks of recruitment to study.
Post-study: 8-10 months after commencing implementation of intervention.
Secondary outcome [10] 407164 0
PRIMARY OUTCOME: Feasibility of Intervention Measure (FIM). Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, et al. (2017). The Feasibility of Intervention Measure is the tool that will be used to assess the feasibility of the F-words for Child Development implementation intervention from the perspectives of therapists.
Timepoint [10] 407164 0
Pre-study: Within 8 weeks of recruitment to study.
Post-study: 8-10 months after commencing implementation of intervention.
Secondary outcome [11] 407532 0
PR:IMARY OUTCOME
Semi-structured 30-60 minute on-line focus group interview with the organisation's F-words implementation team.
The interview gathers qualitative information about team members' perceptions as to the F-words' 1) adoption and penetration (implementation and level of integration); 2) appropriateness (fit, relevance and compatibility); 3) feasibility of use and application; and 4) sustainability, and 5) the supportiveness of the organisational climate and facilitators and barriers to implementation of the F-words at the organisation.
Timepoint [11] 407532 0
Pre-study: Within 8 weeks of recruitment to study.
Post-study: 8-10 months after commencing implementation of intervention.
Secondary outcome [12] 407537 0
PRIMARY OUTCOME
30-60 minute on-line semi-structured individual interviews with organisational leaders. The interviews will gather qualitative information as to leaders' perceptions of the F-words' 1) feasibility (for use and application) and 2) sustainability; and the supportiveness and willingness of the organisational climate and facilitators and barriers to F-words implementation at the organisation.
Timepoint [12] 407537 0
Pre-study: Within 8 weeks of recruitment to study.
Post-study: 8-10 months after commencing implementation of intervention.
Secondary outcome [13] 407557 0
PRIMARY OUTCOME
30-60 minute on-line semi-structured individual interviews with therapists. The interviews will gather qualitative information as to therapists' perceptions of the F-words' 1) appropriateness (fit, relevance, compatibility); and 2) feasibility (for use and application) at the organisation; and 3) the supportiveness and willingness of the organisational climate for F-words implementation.
Timepoint [13] 407557 0
Post-study; 8-10 months after commencing implementation of the intervention.

Eligibility
Key inclusion criteria
Key inclusion criteria for organizational staff:
Organizational leaders will be eligible to be included if they are in a senior, directorship or management role during the one-year evaluation time-line, and influence and support the implementation of the F-words within the organization.

Implementation team members will be eligible to be included if they play an integral role in leading the F-words implementation efforts during the one-year evaluation time-line, in championing the F-words and in sharing them widely with other people.

Therapists will be eligible to be included if they work within the organization and have implemented the F-words during the one year evaluation time-line with families or are working towards implementing the F-words.

Key inclusion criteria for patients and their parent(s):
Children and/or youth will be eligible to be included if they 1) receive services through the organization that are guided by the F-words; 2) receive services within the one-year evaluation timeline; 3) have had the chance to use the F-words; 4) are aged 8-16; and 5) have a means of verbal/non-verbal communication.

Parents/caregivers will be eligible to be included if 1) their 8-16 year old child and/or youth is receiving/has received services through the organization that are guided by the F-words; 2) they receive services within the one-year evaluation timeline; and 3) they are able to communicate using conversational English.
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Organizational leaders and therapists who do not play a role in supporting and implementing the F-words for Child Development within the organization or who have not completed training in the F-words for Child Development will be excluded from the study.

Children whose parents/guardians do not provide consent for their children to participate in the study will be excluded.

Study design
Purpose of the study
Treatment
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
Case evaluation using mixed methods, specifically, following the convergence triangulation model. The design is informed by implementation research theory and involves a pre-post design. Data is gathered with participants before the F-Words intervention is implemented and after the F-Words intervention has been implemented.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is implementation research, the sample size reflects the size of the organization that is the focus.
Within the organization, we hope to have approximately 4 organisational leaders, 6 implementation team members, 10 therapists and 15 parents/caregivers completing the quantitative measures, which is the recommended sample size for pilot studies. All survey data will be analysed through SPSS software using descriptive statistics and t-tests to determine pre-post changes.

It is hoped to involve up to 6 children and up to 15 parents in the qualitative analyses, to support adequate saturation of themes derived from the data.
A content analysis of qualitative data will be undertaken using NVivo Software.
For parents and children in the study, this will be completed by the researchers at AUT determining appropriate codes and categories. A content analysis approach is proposed as it is most appropriate when existing theory or research about the phenomenon/topic of interest exists.This is the case with the F-words, as there is anecdotal evidence supporting its positive impact, and theoretical grounding within the WHO’s ICF framework.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/03/2022
Actual
7/06/2022
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
35
Accrual to date
24
Final
Recruitment outside Australia
Country [1] 24559 0
New Zealand
State/province [1] 24559 0
Auckland

Funding & Sponsors
Funding source category [1] 310716 0
University
Name [1] 310716 0
Auckland University of Technology: Faculty of Health and Environmental Sciences
Country [1] 310716 0
New Zealand
Primary sponsor type
Individual
Name
Dr Margaret Anne Jones
Address
Auckland University of Technology
90 Akoranga Drive,
Northcote,
Private Bag 92006
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 311934 0
Individual
Name [1] 311934 0
Dr Julia Hill
Address [1] 311934 0
Auckland University of Technology
90 Akoranga Drive,
Northcote,
Private Bag 92006
Auckland 1142
New Zealand
Country [1] 311934 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310295 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 310295 0
Ethics committee country [1] 310295 0
New Zealand
Date submitted for ethics approval [1] 310295 0
24/10/2021
Approval date [1] 310295 0
28/01/2022
Ethics approval number [1] 310295 0
2021 FULL 11239
Ethics committee name [2] 310326 0
Auckland University of Technology Ethics Committee
Ethics committee address [2] 310326 0
Ethics committee country [2] 310326 0
New Zealand
Date submitted for ethics approval [2] 310326 0
14/02/2022
Approval date [2] 310326 0
Ethics approval number [2] 310326 0

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

Contacts
Principal investigator
Name 117158 0
Dr Margaret Jones
Address 117158 0
School of Clinical Sciences, Auckland University of Technology, 90 Akoranga Drive, Northcote, Auckland 0627
Country 117158 0
New Zealand
Phone 117158 0
+6499219999 7781
Fax 117158 0
Email 117158 0
margaret.jones@aut.ac.nz
Contact person for public queries
Name 117159 0
Margaret Jones
Address 117159 0
School of Clinical Sciences, Auckland University of Technology, 90 Akoranga Drive, Northcote, Auckland 0627
Country 117159 0
New Zealand
Phone 117159 0
+6499219999 7781
Fax 117159 0
Email 117159 0
margaret.jones@aut.ac.nz
Contact person for scientific queries
Name 117160 0
Margaret Jones
Address 117160 0
School of Clinical Sciences, Auckland University of Technology, 90 Akoranga Drive, Northcote, Auckland 0627
Country 117160 0
New Zealand
Phone 117160 0
+6499219999 7781
Fax 117160 0
Email 117160 0
margaret.jones@aut.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
Sharing individual participant data is not approved by the ethics committee.


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.