Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001022752
Ethics application status
Approved
Date submitted
11/07/2022
Date registered
21/07/2022
Date last updated
14/07/2024
Date data sharing statement initially provided
21/07/2022
Date results provided
26/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the feasibility and acceptability of novel "re-implementation" supports for clinicians who have been trained in Parent-Child Interaction Therapy (PCIT).
Scientific title
Exploring the feasibility and acceptability of novel "re-implementation" supports for clinicians who have been trained in Parent-Child Interaction Therapy (PCIT).
Secondary ID [1] 307532 0
Health Research Council of New Zealand HRC 20/014
Secondary ID [2] 307533 0
Auckland District Health Board A+8704
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood conduct problems 326967 0
Condition category
Condition code
Public Health 324146 324146 0 0
Health service research
Mental Health 324147 324147 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants:
All participants will undertake a two-day Parent-Child Interaction Therapy (PCIT) refresher training, the content of which is informed by PCIT International's 'recalibration' training, and previous research into implementation barriers encountered by PCIT-trained clinicians in Aotearoa / New Zealand. This complimentary, catered training will be delivered outside of typical working hours, to facilitate clinician attendance regardless of their current employment context. It will delivered by a senior PCIT trainer in Tamaki Makaurau / Auckland.

Incorporated within the two training days, all participants will receive the following enhanced supports:
• A collection of resources to support delivery, including detailed virtual delivery resources and demonstration of these. Access to a Dropbox with all resources and materials.
• A complimentary pack of 25 Eyberg Child Behaviour Inventory (ECBI; Eyberg & Pincus, 1999) questionnaires to use with future PCIT clients, and a complimentary PCIT treatment protocol in the event that this has been misplaced since their initial PCIT training.
• Facilitated discussion and problem-solving sessions around using PCIT in various contexts including private practice, should participants choose to do this. For example, what to charge for PCIT, how to obtain referrals, and where suitable clinic rooms are located.
• Discussion, facilitated by a Maori PCIT provider, relating to how to deliver PCIT in a culturally responsive way.

After the two training days, all participants across both the intervention and control groups will be offered optional complimentary weekly 1hr group PCIT-oriented consultation sessions with a senior PCIT clinician, for the six month trial period. Participants may attend in-person, or join remotely via video-conference if they prefer. If the number of participants regularly attending is greater than 12, a second group will be offered.

Intervention:
Clinicians allocated to the intervention condition will receive the following:
• A pack of suitable PCIT toys to use with children and families, which will be provided free of charge.
• Access to a mobile co-worker / ‘PCIT partner’ who can be booked through an online booking system free of charge at any time. This senior PCIT clinician will be available to join a client session to support the clinician (the participating clinician is responsible for obtaining client consent for this to occur), or to plan or debrief sessions, as requested by the clinician, and in any location of the clinician’s choice. It is our intention to recruit a senior Maori PCIT clinician to this role, as Maori are the Indigenous people of Aotearoa / New Zealand and a number of PCIT-trained clinicians are Maori (14.8% in our 2021 survey).
• Access to portable, relocatable audiovisual equipment, including a high quality digital remote camera, which allows viewing of the clinic room from a nearby room. Along with a Bluetooth earpiece to facilitate clinician coaching of the parent(s) from the nearby room.
• Access to an in-room pop-up cubicle to be used if the child requires a brief time-out, that is transportable to the clinic room that the participant clinician is choosing to use for their work.

These components will be available immediately after the refresher training, for the six month trial period. The toy package will be held by the individual participating clinicians, and all other components booked through an online booking system.
Intervention code [1] 323994 0
Behaviour
Intervention code [2] 324007 0
Treatment: Other
Comparator / control treatment
Comparison:
In designing the control condition, our intention was to provide a more active condition than simply (re)training as usual. Given that clinicians have already trained in PCIT previously, we were mindful of enhancing the content so as to make participation worthwhile for clinicians, and to justify the costs associated with replicating the training. As such, and as outlined in ‘All participants’ above, participants in the control condition will receive enhanced refresher training, which includes problem-solving and facilitated planning and implementation discussions, along with basic resources to aid implementation, such as ECBI questionnaires. They will also receive optional complimentary weekly 1hr group PCIT-oriented consultation sessions with a senior PCIT clinician, for the six month trial period. Participants may attend in-person, or join remotely via video-conference. If the number of participants regularly attending is greater than 12, a second group will be offered.
Control group
Active

Outcomes
Primary outcome [1] 331959 0
The primary objective of this pilot study is to assess the feasibility of conducting a RCT. In future, this fully-powered RCT will assess the effects of provision of a re-implementation intervention on adoption of PCIT by clinicians who are not – or are rarely – using PCIT in their practice. The current feasibility trial will identify any factors that may detract from our ability to achieve this aim in the full trial.

Primary outcomes are (1) number of clinicians who enrol in the trial and (2) number of clinicians who complete the trial.

(1) Recruitment processes will be evaluated by assessing the number of clinicians who provide consent to participate in the trial - this will be determined by an audit of study enrolment logs.


Timepoint [1] 331959 0
Baseline (beginning of Day 1 of PCIT refresher training).
Primary outcome [2] 332004 0
(2) Trial procedures will be evaluated by assessing the number of clinicians who complete the trial, as determined by an audit of study logs. Where a clinician withdraws from the study, the point of withdrawal and reason for withdrawal will be recorded.
Timepoint [2] 332004 0
End of trial (six months post randomisation).
Secondary outcome [1] 411736 0
Acceptability of trial processes to participants will be measured by a study-specific survey following the pre-trial information session, and at the end of the trial. Those who choose *not* to enrol in the trial following the information session will also be asked to complete the study-specific survey as to their reasons for non-participation, and a frequency count of responses to these multiple-choice items will be undertaken.


Timepoint [1] 411736 0
Pre-trial information session, end of trial (i.e., six months post randomisation).
Secondary outcome [2] 411822 0
Clinician self-reported Capability, Opportunity and Motivation to use PCIT (drawn from COM-B theory; Michie et al., 2014) will be measured by Likert scale items within a monthly self-report survey, developed for the purposes of this trial, and delivered via Qualtrics.
Timepoint [2] 411822 0
Monthly for the six-month trial period.
Secondary outcome [3] 411823 0
Acceptability of the monthly surveys as a data collection method, and the timing and frequency of these, will be measured by response rates.
Also, a post-trial semi-structured phone interview will incorporate Likert scales and seek participants’ ratings of the acceptability of the monthly surveys as a data collection method.
Timepoint [3] 411823 0
Response rates assessed following each monthly survey, for the six-month period.
Post-trial phone interview at six-months post randomisation.
Secondary outcome [4] 411824 0
Acceptability of each aspect of the re-implementation intervention will be assessed by participant uptake of the components. As an online booking system will be used to co-ordinate the loan of (1) the audiovisual equipment, (2) the time-out cubicle, and (3) the mobile co-worker, a frequency count of weekly bookings will be used as a proxy measure for the acceptability of these items.

Also, in a post-trial semi-structured phone interview, participating clinicians will be asked to rate the acceptability of the components of the re-implementation package on a series of Likert scales.
Timepoint [4] 411824 0
Audit of booking system data: Weekly for the six-month trial period.
Semi-structured interview: End of trial.
Secondary outcome [5] 411825 0
Acceptability of group consultation sessions will be assessed by participant attendance rates, measured by an audit of session attendance registers.
Timepoint [5] 411825 0
Weekly attendance rates, for the six-month trial period.
Secondary outcome [6] 411827 0
Clinician adoption of PCIT will be assessed by clinician self-report of the number of unique families to whom PCIT was delivered in the most recent representative one-week period at six months post-randomisation and compared to baseline (via the study-specific monthly survey). Given that PCIT sessions are typically held weekly, this is expected to provide a valid measure of clinician PCIT adoption.
Timepoint [6] 411827 0
Baseline (beginning of Day 1 of PCIT refresher training), and end of trial (six months post randomisation).
Secondary outcome [7] 411947 0
Acceptability of the recruitment and trial processes to Maori clinicians will be assessed by multiple-choice items within a study-specific questionnaire following the pre-trial information session and at the end of the trial. Maori clinicians choosing not to enrol in the trial will also be offered the opportunity to speak kanohi-ki-te-kanohi (face to face) or via phone with a Maori research team member, to discuss their impressions and any concerns about trial recruitment processes and/or methodology that contributed to their decision not to participate, and this qualitative data will be recorded.
Timepoint [7] 411947 0
Pre-trial information session, end of trial (six months post randomisation).

Eligibility
Key inclusion criteria
Clinicians must have completed a recognised 40-hour initial training in PCIT within the past 10 years and be registered to practise in Aotearoa / New Zealand at the time of participation in the trial. Having been eligible for the PCIT initial training implies that included clinicians will be allied health and medical clinicians with a Masters degree or equivalent (i.e. psychologists, psychiatrists, social workers, psychotherapists, occupational therapists, and nurses). Eligible clinicians are not required to be employed in a clinical role, and may be in an administrative or managerial role, as it is possible that they may elect to adopt PCIT in a part-time private practice context. Where the clinician is already seeing a full caseload of PCIT clients, they will remain eligible for inclusion as we are interested in whether provision of additional supports might influence the nature and quality of implementation. For example, the PCIT treatment protocol recommends use of a time-out room in the Parent-Directed Interaction phase, and clinicians have indicated that this requirement can be problematic, which at times results in this phase being omitted or adapted (Woodfield et al., 2021).

Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clinicians who are based outside of the Tamaki Makaurau / Auckland region will be excluded from this pilot trial, due to resource constraints, as the mobile co-worker will be Tamaki Makaurau / Auckland-based in the pilot trial.

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)
Allocation to groups will occur at the end of the second day of refresher training. Participants will be given the next sealed envelope in the sequence at the conclusion of the second day of training by a member of the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random allocation sequence will have been generated by the study statistician (using a simple 1:1 randomisation with no restrictions), who will have arranged a series of sealed opaque envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographic and other characteristics of clinicians who enrol in the trial will be assessed via a bespoke baseline online Qualtrics survey administered on the first refresher training day. These will be compared with demographic data obtained during our earlier surveys to determine the representativeness of the group of clinicians who choose to enrol in this trial. Our earlier survey had a response rate of 67%, so is assumed to provide a reasonable indication of the demographic characteristics of the population of PCIT-trained clinicians in Aotearoa / New Zealand (Woodfield et al., 2020).

Sample size and justification
As this is a feasibility study, sample size calculations are not required, and a formal power calculation is not appropriate, given that the primary outcome for this pilot is feasibility (Thabane et al., 2010). Instead, sample sizes for feasibility studies should be based on pragmatic considerations (NIH: National Center for Complementary and Integrative Health). However, for the RCT it is envisaged that the primary outcome will be adoption: clinician self-report of the number of unique families to whom PCIT was delivered in the most recent representative one-week period at six months post-randomisation, compared to baseline. These data will be collected.

Relevant pragmatic considerations included the size of the group of PCIT-trained clinicians thought to be practicing in the Tamaki Makaurau / Auckland region, excluding the research team (approximately 70). Also, the budget for the research project will only support limited co-worker hours, and the purchase of one time-out pop-up cubicle and limited audio-visual equipment and toy packages. Given these practical constraints, we hope to recruit 10 participants per condition, or 20 overall. We are interested in evaluating whether the proposed recruitment methods will be effective in a future, larger trial. As such, while we will aim to recruit this number, our ability to do so will provide valuable data around our ability to recruit sufficient participants for a fully powered trial using the described methods.

Statistical methods
The purpose of pilot studies is not to test hypotheses, and as such, inferential statistics are not required (NIH: National Center for Complementary and Integrative Health). Descriptive statistics will predominantly be used to summarise participant characteristics and outcome measures. While it is acknowledged that the smaller sample size associated with pilot studies can provide unstable effect size estimates, we intend to carry out some exploratory analyses alongside descriptive statistics for clinician adoption of PCIT, by way of a two sample t-test. If required, we will adjust for baseline differences using linear regression. Measures of variance on this outcome variable will be used to inform the design of a definitive RCT.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/07/2022
Actual
30/07/2022
Date of last participant enrolment
Anticipated
31/08/2022
Actual
9/09/2022
Date of last data collection
Anticipated
13/03/2023
Actual
1/06/2023
Sample size
Target
20
Accrual to date
Final
14
Recruitment outside Australia
Country [1] 24886 0
New Zealand
State/province [1] 24886 0
Auckland

Funding & Sponsors
Funding source category [1] 311809 0
Government body
Name [1] 311809 0
Health Research Council of New Zealand
Country [1] 311809 0
New Zealand
Primary sponsor type
University
Name
University of Auckland | Waipapa Taumata Rau
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 313284 0
Hospital
Name [1] 313284 0
Te Whatu Ora | Health New Zealand | (formerly Auckland District Health Board)
Address [1] 313284 0
Research Office
Level 14, Support Building, Auckland City Hospital
Private Bag 92024, Auckland, New Zealand 1001
Country [1] 313284 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311253 0
Auckland Health Research Ethics Committee (AHREC)
Ethics committee address [1] 311253 0
Ethics committee country [1] 311253 0
New Zealand
Date submitted for ethics approval [1] 311253 0
Approval date [1] 311253 0
08/07/2022
Ethics approval number [1] 311253 0
AH24443

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

Contacts
Principal investigator
Name 120470 0
Dr Melanie Woodfield
Address 120470 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland | Waipapa Taumata Rau
Private Bag 92019
Auckland 1142
Country 120470 0
New Zealand
Phone 120470 0
+64 9 373 7599
Fax 120470 0
Email 120470 0
[email protected]
Contact person for public queries
Name 120471 0
Melanie Woodfield
Address 120471 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland | Waipapa Taumata Rau
Private Bag 92019
Auckland 1142
Country 120471 0
New Zealand
Phone 120471 0
+64 9 373 7599
Fax 120471 0
Email 120471 0
[email protected]
Contact person for scientific queries
Name 120472 0
Sarah Hetrick
Address 120472 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland | Waipapa Taumata Rau
Private Bag 92019
Auckland 1142
Country 120472 0
New Zealand
Phone 120472 0
+64 9 373 7599
Fax 120472 0
Email 120472 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
Not included in application for ethics approval.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16595Study protocol  [email protected]
16597Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a randomised pilot study of a novel Parent-Child Interaction Therapy (PCIT) 're-implementation' intervention.2023https://dx.doi.org/10.1186/s40814-023-01309-y
N.B. These documents automatically identified may not have been verified by the study sponsor.