Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000237482p
Ethics application status
Submitted, not yet approved
Date submitted
7/01/2025
Date registered
1/04/2025
Date last updated
1/04/2025
Date data sharing statement initially provided
1/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A co-designed school-based early intervention involving parent-teacher collaboration to improve mental health and wellbeing in diverse children with disruptive disorders
Scientific title
A co-designed school-based early intervention involving parent-teacher collaboration to improve mental health and wellbeing in diverse children with disruptive disorders
Secondary ID [1] 313538 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a follow-up study of ACTRN12619000967189

Health condition
Health condition(s) or problem(s) studied:
Conduct Disorder 336012 0
Callous-Unemotional Traits 336013 0
Mental Health 336014 0
Oppositional Defiant Disorder 336010 0
Disruptive Behaviour Disorder 336011 0
Condition category
Condition code
Mental Health 332590 332590 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary aim of this project is to improve the mental health and wellbeing of the most vulnerable Australian children by delivering an accessible, comprehensive school-based early intervention—iteratively co-designed with school endusers—to diverse children with disruptive behaviour disorders living in culturally and linguistically diverse (CALD) and rural communities.
Standard PCIT
Standard Parent Child Interaction Therapy (PCIT), is a highly efficacious ‘Parent Management Training’ (PMT) program—the first line and gold-standard intervention for disruptive child behaviour recommended by professional groups in Australia and worldwide. Mechanisms underpinning disruptive behaviour change in PMT are reduced harsh/inconsistent and increased positive parenting behaviours, which breaks the cycle of inadvertent maintenance of disruptive behaviour that occurs via coercive and inconsistent exchanges between parent and child. PCIT produces significant improvements in parent-reported and observed child disruptive behaviours with large effect sizes among children within our target age range (i.e., 7 and under), such that post-intervention disruptive behaviour returns to within normal limits and gains are sustained up to six years post-treatment. PCIT is identified as a transdiagnostic intervention that produces secondary improvements in children’s internalising problems (i.e., anxiety, depression), observed parenting skills, parent stress and mental health symptoms, and overall family functioning. PCIT’s efficacy is attributed to its intensive coaching method involving the parent-child dyad in most sessions. PCIT uses real-time, bug-in-ear technology to provide live coaching and immediate feedback to parents from a clinician observing the parent-child dyad from behind a one-way mirror. For these reasons, PCIT was selected for adaptation for School-based delivery and complex presentations.

Treatment matching for complex conduct problems
PCIT-CU is an adaptation of PCIT developed by CIA to target the unique treatment needs of children with callous unemotional traits and refined using researcher, clinician, and carer feedback over more than a decade. This matched v. non-matched design is based on: (a) meta-analytic research finding that children with CU traits start and end PMT with more severe conduct problems that do not normalise, and (b) post-treatment improvements in the conduct problems of clinic-referred children with CU traits deteriorated for those randomised to standard PCIT, but sustained to follow-up for children randomised to PCIT-CU in an RCT.

School PCIT adaptation
School-based PCIT/PCIT-CU addresses access barriers and enhances intervention effectiveness by improving teacher behaviour management skills and student-teacher relationships, ensuring better generalisation of benefits to the school setting.

Targeted Intervention
School PCIT involves the target student’s teaching team in PCIT/PCIT-CU sessions, where teachers or support staff receive real-time coaching via a bug-in-the-ear device while interacting with the student, fostering parent-teacher collaboration and consistency across home and school to support lasting behavioural change.
Universal Teacher Workshop
In response to advisory group feedback and aligning with national and state education priorities, our team developed an 8-hour professional learning workshop, delivered by a certified PCIT Trainer, with a pilot trial of its self-directed online format showing significant improvements in teachers’ mental health literacy on childhood disruptive behaviour. The workshops will be delivered across the school year, with the immediate treatment group participating in Year 1 and the waitlist control group in Year 2.
Adapting treatment for non-English speaking CALD families
This project builds on our proof-of-concept trial by testing an interpreter-assisted adaptation of School PCIT to overcome language barriers for non-English speaking families, where a trained interpreter relays real-time coaching from the therapist via a bug-in-ear device, ensuring accessibility, cultural sensitivity, and effective intervention delivery.

Treatment procedure
Children and parents will complete 14 (Standard ‘School PCIT’) to 21 (‘School PCIT-CU’ with a 7-session adjunctive module) weekly, one-hour sessions delivered by a PCIT clinician. The intervention consists of three phases: Child-Directed Interaction (CDI) to strengthen parent-child relationships through positive attention; Parent-Directed Interaction (PDI) to address chronic non-compliance, aggression, and destructiveness with effective discipline; and CARES to build prosocial behaviours and emotional skills like empathy and anger regulation. Teaching staff will join at least four sessions, receiving real-time coaching while interacting with the student, and will observe parents being coached, just as parents will observe teachers. Adherence will be assessed via attendance, homework completion, clinician alliance, and caregiver satisfaction. One primary caregiver will participate in assessments, but all caregivers are encouraged to attend, as father involvement enhances outcomes. The number of sessions completed by educators and parents will be recorded. If a family has multiple children with clinical conduct issues, the child causing the greatest distress will be enrolled, with parents encouraged to practise skills with all siblings in the PCIT age range (2.5–7 years).
Intervention code [1] 330425 0
Behaviour
Intervention code [2] 330130 0
Treatment: Other
Comparator / control treatment
This study uses a parallel, two-arm, cluster randomised effectiveness trial design involving NSW public primary school partners. To mitigate the risk of selection bias, participating schools will be randomised using a computer-generated randomisation schedule to receive either the enhanced intervention or no intervention. Intervention schools will receive the enhanced intervention for 12 months, after which control arm schools will receive the intervention. A cluster randomisation approach at the school level was selected to mitigate the risk of contamination from teachers passing on resources or knowledge to other teachers within the same school. Trial management will take place from UNSW’s Parent-Child Research Clinic.
Control group
Active

Outcomes
Primary outcome [1] 340105 0
Changes in frequency and number of conduct problems, assessed via the Eybery Child Behavior Inventory (ECBI; parent-report) and Sutter-Eyberg Student Behavior Inventory - Revised (SESBI-R; teacher-report).
Timepoint [1] 340105 0
Assessed at baseline, pre-treatment (waitlist control group only), post-treatment (following 14 or 21 weeks of treatment; primary outcome), and three months post treatment completion. Change in outcomes will be compared between conditions from baseline to post-treatment for the immediate treatment group and from baseline to pre-treatment for the waitlist control group.
Primary outcome [2] 340106 0
Changes in anxiety and depressive symptoms assessed as a composite internalising problems outcome via ASEBA Child Behaviour Checklist (ASEBA CBCL; parent-report).
Timepoint [2] 340106 0
Assessed at baseline, pre-treatment (waitlist control group only), post-treatment (following 14 or 21 weeks of treatment; primary outcome), and three months post treatment completion. Change in outcomes will be compared between conditions from baseline to post-treatment for the immediate treatment group and from baseline to pre-treatment for the waitlist control group.
Primary outcome [3] 340107 0
Changes in child disruptive behaviour diagnostic status, assessed via the Oppositional Defiant Disorder and Conduct Disorder modules of the Diagnostic Interview Schedule for Children, Adolescents, and Parents (DISCAP; clinician-rated following structured interview with caregiver).
Timepoint [3] 340107 0
Assessed at baseline, pre-treatment (waitlist control group only), post-treatment (following 14 or 21 weeks of treatment; primary outcome), and three months post treatment completion. Change in outcomes will be compared between conditions from baseline to post-treatment for the immediate treatment group and from baseline to pre-treatment for the waitlist control group.
Secondary outcome [1] 442729 0
Acceptability of intervention, assessed via (1) attendance and engagement (i.e., missed sessions, re-scheduled sessions, sessions ended early, homework compliance, and premature drop-out], (2) treatment fidelity (i.e., adherence to session-by-session treatment fidelity checklists as coded by masked, independent evaluators from session video recordings).
Timepoint [1] 442729 0
Weekly during treatment phase, post-treatment (following 14 or 21 weeks of treatment), and three months post treatment completion.
Secondary outcome [2] 443527 0
Amount of paraprofessional support in mainstream classroom assessed using count data of number of hours of support.
Timepoint [2] 443527 0
Pre-treatment (waitlist control group only), post-treatment (following 14 or 21 weeks of treatment), and three months post treatment completion. Change in outcomes will be compared between conditions from baseline to post-treatment for the immediate treatment group and from baseline to pre-treatment for the waitlist control group.
Secondary outcome [3] 444403 0
Additional Primary Outcome. Treatment satisfaction of interpreter-delivered intervention for parents without English fluency, assessed via the forward and backward translated measure of the Therapy Attitude Inventory (TAI) in their own language.
Timepoint [3] 444403 0
Post-treatment (following 14 or 21 weeks of treatment), and three months post treatment completion.
Secondary outcome [4] 444404 0
Number of special education or remedial classes required assessed using count data of number of classes required.
Timepoint [4] 444404 0
Pre-treatment (waitlist control group only), post-treatment (following 14 or 21 weeks of treatment), and three months post treatment completion. Change in outcomes will be compared between conditions from baseline to post-treatment for the immediate treatment group and from baseline to pre-treatment for the waitlist control group.
Secondary outcome [5] 442725 0
Additional Primary Outcome. The feasibility of interpreter-delivered intervention for parents without English fluency, assessed as a composite primary outcome via the forward and backward translated measure of Barriers to Treatment Participation Scale (BTPS) and session attendance, compliance with and session homework demands, returned homework sheets, and attrition rates.
Timepoint [5] 442725 0
Weekly during treatment phase, post-treatment (following 14 or 21 weeks of treatment).
Secondary outcome [6] 443525 0
Changes in child sensitivity to distress cues, assessed via Emotional Pictures Dot-Probe task, Emotion Recognition task, and Emotion-induced Blindness task (Preschool versions) (child laboratory task).
Timepoint [6] 443525 0
Assessed at baseline, pre-treatment (waitlist control group only), post-treatment (following 14 or 21 weeks of treatment), and three months post treatment completion. Change in outcomes will be compared between conditions from baseline to post-treatment for the immediate treatment group and from baseline to pre-treatment for the waitlist control group. Meditation of post-treatment and follow-up conduct problem and CU trait outcomes will be tested using post-treatment assessment of mediators.
Secondary outcome [7] 443526 0
Additional composite primary outcome. Cost-effectiveness, assessed as a composite primary outcome via a parent-reported resource use questionnaire used within the child mental health context, including interventions delivered within school contexts. It will be adapted for the current study context. Parents will also be asked for permission to access administrative health service use data (including Medicare and Pharmaceutical Benefits Scheme service use data). Quality of life will be assessed in children using the Child Health Utility (CHU 9D) measure, and in parents using the Assessment of Quality of Life 4D (AQoL 4D) questionnaire. Both questionnaires can be used to estimate quality adjusted-life years (QALYs) that are a commonly used measure in economic evaluations of health focused interventions, including school based mental health interventions. The costs of implementing the intervention will be assessed using study financial records as well as resource interviews with each school to determine other resources that were used by school staff to address disruptive behaviours (e.g., student learning support officers (SLSOs)).
Timepoint [7] 443526 0
Pre treatment phase, pre-treatment (waitlist control group only), post-treatment (following 14 or 21 weeks of treatment), and three months post treatment completion.
Secondary outcome [8] 444401 0
Additional primary outcome. Callous-unemotional traits, assessed via the Inventory of Callous-Unemotional Traits (ICU), Preschool Version (parent- and teacher-report) and the Clinical Assessment of Prosocial Emotions (CAPE) (clinician-administered structured interview).
Timepoint [8] 444401 0
Assessed at baseline, pre-treatment (waitlist control group only), post-treatment (following 14 or 21 weeks of treatment; primary outcome), and three months post treatment completion. Change in outcomes will be compared between conditions from baseline to post-treatment for the immediate treatment group and from baseline to pre-treatment for the waitlist control group.
Secondary outcome [9] 443523 0
Additional Primary Outcome. Mechanisms of therapeutic change. Changes in parent-child and teacher-student interactions (i.e., child compliance, and caregiver warmth/affection/responsivity/consistency), assessed via the Dyadic Parent-Child Interaction Coding System, 4th Edition (DPICS-IV) (observational coding system) and Warmth Affection Coding System (WACS).
Timepoint [9] 443523 0
Assessed at baseline, pre-treatment (waitlist control group only), post-treatment (following 14 or 21 weeks of treatment; primary outcome), and three months post treatment completion. Change in outcomes will be compared between conditions from baseline to post-treatment for the immediate treatment group and from baseline to pre-treatment for the waitlist control group. Meditation of post-treatment and follow-up conduct problem and CU trait outcomes will be tested using post-treatment assessment of mediators.
Secondary outcome [10] 443524 0
Changes in parental warmth towards child. Measured via the Parental Affection Warmth Scale (PAWS). The PAWS (Koh et al., 2024) is a comprehensive 29-item parent self-report questionnaire that measures parental warmth toward young children aged 2-8 years. PAWS scores demonstrate internal consistency and convergent, discriminant, and concurrent validity in the age group included in this trial (Koh et al., 2024).
Timepoint [10] 443524 0
Pre treatment phase, post-treatment (following 14 or 21 weeks of treatment), and three months post treatment completion. Change in outcomes will be compared between conditions from baseline to post-treatment for the immediate treatment group and from baseline to pre-treatment for the waitlist control group. Meditation of post-treatment and follow-up conduct problem and CU trait outcomes will be tested using post-treatment assessment of mediators.
Secondary outcome [11] 444402 0
Additional Primary Outcome. The acceptability of interpreter-delivered intervention for parents without English fluency, assessed via the forward and backward translated measure of therapeutic alliance Working Alliance Inventory (WAI) in their own language.
Timepoint [11] 444402 0
Post-treatment (following 14 or 21 weeks of treatment), and three months post treatment completion.
Secondary outcome [12] 444405 0
Number of referrals for behaviour problems assessed using count data of number of referrals.
Timepoint [12] 444405 0
Pre-treatment (waitlist control group only), post-treatment (following 14 or 21 weeks of treatment), and three months post treatment completion. Change in outcomes will be compared between conditions from baseline to post-treatment for the immediate treatment group and from baseline to pre-treatment for the waitlist control group.

Eligibility
Key inclusion criteria
Inclusion criteria include:
(a) Child in preschool, Kindergarten, Year 1, or Year 2
(b) a score in the clinically significant range (T-scores > 64 or 70, depending on scale) on at least one of the following ASEBA disruptive behaviour problem scales according to parent and teacher report (combined by taking the maximum score across raters on each item): aggressive behaviour, rule breaking, DSM ODD or conduct problems, or externalising composite.
(c) parent or teacher of child meeting inclusion criteria.
(d) teachers of Pre-K to Yr 2 students at participating partner schools
Minimum age
2 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include:
(a) children with a primary mental health diagnosis other than ODD/CD (e.g., moderate/severe autism spectrum, intellectual disability), or
(b) children who are deaf, or
(c) children who are receiving concurrent psychological treatment for disruptive behaviour problems.
(d) only one eligible child per household will be permitted to enrol.
(e) children of parents with a serious mental health disorder that may interfere with the intervention.

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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation using randomisation table created by computer software.
Factor: geographic region (urban/metropolitan; rural/regional) and school size (>= v. <300 students).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
To mitigate the risk of selection bias, participating schools will be randomised using a computer-generated randomisation schedule to receive either the enhanced intervention or no intervention (‘services as usual’ control arm), stratified by geographic region (urban/metropolitan; rural/regional) and school size (>= v. <300 students), after participant consent and baseline data collection.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed models (LMM) will be used to test the first hypothesis: School PCIT will improve student outcomes relative to waitlist control. Separate LLMs will be specified using the three assessment points (pre-intervention, immediately and 3 months post-intervention). A conditional model including random intercepts for individual/school and appropriate covariance structure, fixed effects of assessment point (plus any warranted covariates), and restricted maximum likelihood estimation to account for missing data will be tested using data from the full intent-to-treat sample. Power Analysis. Using PASS 2020, assuming a 1.00 mean difference at the final time point, common SD of 1.00, average of 10 children per school, and equal allocation of schools to treatment arm, with N=160 individuals there would be >90% power to detect this difference. Using parameters obtained from our pilot study, a correlation among repeated measures of 0.3 and among children within a school of 0.05 was specified, with alpha set to 0.05. To account for 24% attrition from our pilot trial, 211 students in total will be needed. This sample size will also achieve greater than 90% power to detect within-group change of 1 SD over the course of the study. This recruitment target is practically feasible with each of the three site’s on-site clinic suite being able to serve 40 students per year (120 families treated per year) across the two project years. Logistic regression analyses and independent samples t-tests will be used to test whether intervention adherence, acceptability and therapeutic alliance differ between families receiving School PCIT and non-English speaking families receiving interpreter-assisted treatment (Aim 2). Mediation of improvement in child outcomes via change in caregiver (parent, teacher) use of more positive management strategies, increased warmth, less harsh/ coercive strategies, and improved child emotional attention and recognition (i.e., mediators) will be tested using latent growth mediation models (Aim 3). The economic evaluation (Aim 4) will comprise a cost-utility analysis and cost-effectiveness analysis. Costs and outcomes of the proposed interventions will be determined using the clinical outcomes (for cost-effectiveness) and quality-adjusted life years (QALYs; calculated using CHU9D and AQoL-4 [for cost-utility analyses]). Costs will be determined by including intervention costs and the costs of services that may be impacted because of the intervention (assessed using RUQ and administrative data). Standardised statistical techniques accounting for clustering will be used to assess the differences between costs and QALYs of the groups (including generalised linear models) and bootstrapping will be used to determine the uncertainty interval of the incremental cost-effectiveness ratio. Potential budget impact of the roll-out of the intervention will also be determined. Depending on the outcomes of the study, longer term impacts of the intervention will also be considered (e.g., longer-term cost impacts of reduced disruptive behaviours). However more detailed economic modelling is beyond the scope of this incubator grant, but can be assessed in a subsequent more definitive systems level modelling project.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/06/2025
Actual
Date of last participant enrolment
Anticipated
8/06/2026
Actual
Date of last data collection
Anticipated
2/01/2027
Actual
Sample size
Target
211
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 43483 0
2170 - Liverpool
Recruitment postcode(s) [2] 43482 0
2565 - Ingleburn
Recruitment postcode(s) [3] 43489 0
2213 - Panania
Recruitment postcode(s) [4] 43484 0
2170 - Warwick Farm
Recruitment postcode(s) [5] 43485 0
2560 - Kentlyn
Recruitment postcode(s) [6] 43492 0
2211 - Padstow
Recruitment postcode(s) [7] 43490 0
2213 - Picnic Point
Recruitment postcode(s) [8] 43487 0
2200 - Bankstown
Recruitment postcode(s) [9] 43493 0
2640 - Albury
Recruitment postcode(s) [10] 43486 0
2566 - St Andrews
Recruitment postcode(s) [11] 43491 0
2212 - Revesby
Recruitment postcode(s) [12] 43495 0
2641 - Lavington
Recruitment postcode(s) [13] 43494 0
2640 - Glenroy
Recruitment postcode(s) [14] 43496 0
2642 - Jindera
Recruitment postcode(s) [15] 43488 0
2200 - Condell Park

Funding & Sponsors
Funding source category [1] 317999 0
Charities/Societies/Foundations
Name [1] 317999 0
Cybec Foundation
Country [1] 317999 0
Australia
Funding source category [2] 317998 0
Government body
Name [2] 317998 0
National Health and Medical Research Council - Medical Research Future Fund
Country [2] 317998 0
Australia
Funding source category [3] 318001 0
Other
Name [3] 318001 0
Condell Park Public School
Country [3] 318001 0
Australia
Funding source category [4] 318002 0
Other
Name [4] 318002 0
Albury North Public School
Country [4] 318002 0
Australia
Funding source category [5] 318000 0
Other
Name [5] 318000 0
Ingleburn Public School
Country [5] 318000 0
Australia
Primary sponsor type
Individual
Name
Professor Eva Kimonis, University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 320702 0
None
Name [1] 320702 0
Address [1] 320702 0
Country [1] 320702 0
Other collaborator category [1] 283345 0
Individual
Name [1] 283345 0
Dr Natalie Goulter, Flinders University
Address [1] 283345 0
Country [1] 283345 0
Australia
Other collaborator category [2] 283343 0
Individual
Name [2] 283343 0
Professor Catherne Mihalopoulos, Monash University
Address [2] 283343 0
Country [2] 283343 0
Australia
Other collaborator category [3] 283344 0
Individual
Name [3] 283344 0
Dr Georgette Fleming, University of New South Wales
Address [3] 283344 0
Country [3] 283344 0
Australia
Other collaborator category [4] 283346 0
Individual
Name [4] 283346 0
Dr Natalie Taylor, University of New South Wales
Address [4] 283346 0
Country [4] 283346 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316663 0
The University of New South Wales Human Research Ethics Committee C
Ethics committee address [1] 316663 0
Ethics committee country [1] 316663 0
Australia
Date submitted for ethics approval [1] 316663 0
13/01/2025
Approval date [1] 316663 0
Ethics approval number [1] 316663 0

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

Contacts
Principal investigator
Name 55602 0
Prof Eva Kimonis
Address 55602 0
UNSW Parent-Child Research Clinic, School of Psychology, Mathews Building, University of New South Wales Sydney NSW 2052
Country 55602 0
Australia
Phone 55602 0
+61 2 93852323
Fax 55602 0
Email 55602 0
[email protected]
Contact person for public queries
Name 55603 0
Eva Kimonis
Address 55603 0
UNSW Parent-Child Research Clinic, School of Psychology, Mathews Building, University of New South Wales Sydney NSW 2052
Country 55603 0
Australia
Phone 55603 0
+61 2 93852323
Fax 55603 0
Email 55603 0
[email protected]
Contact person for scientific queries
Name 55604 0
Eva Kimonis
Address 55604 0
UNSW Parent-Child Research Clinic, School of Psychology, Mathews Building, University of New South Wales Sydney NSW 2052
Country 55604 0
Australia
Phone 55604 0
+61 2 93852323
Fax 55604 0
Email 55604 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.