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Trial registered on ANZCTR


Registration number
ACTRN12619000967189
Ethics application status
Approved
Date submitted
17/06/2019
Date registered
9/07/2019
Date last updated
9/07/2019
Date data sharing statement initially provided
9/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving mental health outcomes through parent engagement in school-based early intervention
Scientific title
Improving mental health outcomes through parent engagement in school-based early intervention
Secondary ID [1] 298516 0
None
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Disruptive Behaviour Disorder 313318 0
Oppositional Defiant Disorder 313319 0
Conduct Disorder 313320 0
Callous-Unemotional Traits 313321 0
Condition category
Condition code
Mental Health 311760 311760 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participating families will be randomly allocated to either standard, in-clinic Parent-Child Interaction Therapy (PCIT) or an adaptation of PCIT for children who show clinically significant levels of conduct problems and callous-unemotional (CU) traits (e.g., lack of empathy/guilt, uncaring attitudes), referred to as PCIT-CU. CU traits are known diagnostically as "with limited prosocial emotions".

Standard PCIT:
Standard PCIT is a clinic-based protocol, which draws on real-time, wireless technology to provide in vivo coaching of parent-child interactions by a therapist observing the parent-child dyad from behind a one-way mirror. Treatment is divided into 2 phases: (1) Child-Directed Interaction (CDI) and (2) Parent-Directed Interaction (PDI).
During CDI, parents are coached in traditional play therapy skills, including following the child’s lead, describing the actions of the child, and reflecting and imitating the child’s appropriate speech and play. Parents are taught to consistently attend to and reinforce positive child behaviours via five "do" skills, including descriptive praise, descriptions of appropriate child behaviour, reflections of appropriate child speech, imitations of appropriate child behaviour, and verbal and non-verbal expressions of enjoyment, while simultaneously withdrawing their attention from negative, inappropriate behaviours. During CDI, the overall purpose of applying these skills is to improve the quality of the parent-child relationship.
During PDI, parents are coached to set limits and provide appropriate, consistent consequences for inappropriate behaviour (e.g., time-out). The overall purpose of PDI is to reduce the frequency and intensity of disruptive child behaviour, and to allow parents to effectively manage disruptive behaviour if/when it does occur.
The first treatment session of each phase begins with a Teach session during which parents are taught specific skills, which are then practiced in the following Coach sessions. In standard PCIT, treatment dosage varies between families because transition between phases and to graduation from treatment depends on parents reaching a prescribed level of the phase-specific skills (‘mastery criteria’). However, prior research indicates improved outcomes and lower attrition rates using a fixed approach to dosage, whereby transition through and from treatment occurs after completing a pre-specified number of sessions, rather than a variable approach that requires reaching skill mastery. The current protocol utilises this fixed approach, with all families receiving 14 weekly, one-hour treatment sessions during the CDI and PDI phases (one CDI Teach session and six CDI Coach sessions, and one PDI Teach sessions and six PDI Coach sessions). This treatment dose is consistent with the average number of PCIT sessions completed in prior research (i.e., 12-16 sessions). Families allocated to the standard PCIT treatment condition will receive an additional seven weekly telephone consults following the PDI phase (to control for possible differential dose effects, given families allocated to the PCIT-CU condition receive an additional seven treatment sessions [see below]). These calls elicit updates regarding behavioural difficulties, and involve therapists assisting parents to apply PCIT skills to manage difficulties. In total, families allocated to standard PCIT will receive a total of 21 sessions (14 face-to-face, 7 telephone-based) delivered weekly. The therapy will be delivered by a therapist certified in standard PCIT, delivered one-on-one in school-based research clinic.

PCIT-CU:
PCIT-CU builds upon standard PCIT by (a) explicitly coaching parents in CDI to increase their warm/affectionate behaviours and responsivity to the child to enhance development of empathy and guilt, (b) systematically supplementing punishment-based strategies in PDI with reward-based techniques, and (c) training parents to deliver emotional skill-building instruction to the child via a 7-session adjunctive module (called "CARES"; Coaching and Rewarding Emotional Skills) that intensively targets children's insensitivity to others’ distress cues.
The adapted CDI-CU phase (sessions 1-7) begins with a Teach session educating parents on the importance of warm/affectionate and emotionally responsive parenting, and CDI-CU skills are taught and modelled. The fifth of five CDI “Do” skills is adapted to explicitly train and coach parents to express warm and affectionate behaviours (e.g., positive touch, increased eye contact) towards child. This skill is called "Emotional Expression". Components of standard PCIT maintained in the CDI-CU phase include increasing attention to positive child behaviours and reducing control and criticism of the child. Following the initial CDI-CU Teach session, families complete six CDI-CU coaching sessions, during which parents receive in vivo coaching by a therapist from behind a one-way mirror while practicing CDI-CU skills in play with the child. The CDI-CU phase is hypothesised to increase parental physical affection and responsivity.
The adapted PDI-CU phase (sessions 8-14) phase integrates an individualised token system directly into the standard PCIT discipline sequence. Standard PCIT components of effective commands, ignoring minor misbehaviours, and time-out following child noncompliance and other problem behaviours are maintained, but the latter is de-emphasised. PDI-CU begins with a Teach session educating parents on effective commands and the importance of reward-based strategies with children with co-occurring conduct problems and CU traits. The PDI-CU discipline sequence is modelled and role-played with parents and children in the first coach session before in vivo coaching begins, and continues for five additional PDI-CU sessions. Children earn tokens for positive behaviours (e.g., compliance, prosocial behaviours) and for 'positive opposites' of negative behaviours (e.g., praise of manner instead of swearing). Barriers and issues arising in implementation of PDI-CU skills in the home are addressed in each session. PDI-CU is hypothesised to increase parental consistency in using an individualised token system to more intensively reinforce child compliance and other positive behaviours, relative to praise alone.
The novel, adjunctive CARES module (sessions 15-21) applies basic science findings and evidence-based practices to target emotional deficits in children with conduct problems and CU traits by training parents to engage in emotional skills building activities with the child. The six CARES foci are: (1) refocusing attention to facial micro-expressions (e.g., changes in the eye region) to teach better identification and interpretation of others’ feeling states, particularly distress; (2) developing emotional language; (3) teaching the importance of context and perspective taking when interpreting meaning in emotional displays; (4) using modelling, role-play, and social scripts to teach children to engage in empathic, prosocial behaviour; (5) using positive reinforcement established in earlier phases (praise, token system) to encourage prosocial behaviour and motivate compliance with learning activities; and (6) teaching developmentally appropriate cognitive-behavioural strategies to address reactive aggression stemming from frustration-based anger when reward driven behaviours of children with co-occurring conduct problems and CU traits are thwarted. A discussion on when and how to phase out the token system initiated in PDI-CU occurs during the final CARES session. CARES is hypothesised to improve CU traits and empathy by improving childrens’ distress sensitivity.
As in the standard PCIT protocol, PCIT-CU CDI/PDI will be delivered in a total of 14 weekly, one hour treatment sessions (one CDI-CU Teach session and six CDI-CU Coach sessions, and one PDI-CU Teach sessions and six PDI-CU Coach sessions), with the PCIT-CU families receiving an additional seven weekly treatment sessions following the PDI phase, meaning that families allocated to PCIT-CU will receive a total of 21 face-to-face sessions delivered weekly. The therapy will be delivered by a therapist certified in standard PCIT and trained in the adapted protocol, delivered one-on-one in school-based research clinic. To avoid intervention cross-over that could threaten the integrity of the study, different therapists will deliver standard PCIT and PCIT-CU treatments, and within each condition there will be two therapists to avoid confounding therapist and treatment.

Adherence to the standard and enhanced PCIT protocols will be monitored via the number of sessions that participating families attend, as well as adherence to session and homework demands/requirements (i.e., five minutes of daily skill practice).
Intervention code [1] 314767 0
Treatment: Other
Comparator / control treatment
This trial has been designed to test the acceptability and efficacy of intervention matched to the individual needs of young children with conduct problems. Following a comprehensive assessment, children will be classified as either "conduct problems with normative CU traits" or "conduct problems with elevated CU traits". Children in the "conduct problems with normative CU traits" group will be randomly allocated to receive either standard PCIT (matched treatment) or PCIT-CU (non-matched treatment). Children in the "conduct problems with elevated CU traits" group will be randomly allocated to receive standard PCIT (non-matched treatment) or PCIT-CU (matched treatment). Accordingly, this study involves an active control condition, such that PCIT-CU will be compared against standard PCIT and will be the control treatment for children classified as having "conduct problems with normative CU traits", while standard PCIT will be compared against PCIT-CU and will be the control treatment for children classified as having "conduct problems with elevated CU traits".
Control group
Active

Outcomes
Primary outcome [1] 320443 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] 320443 0
Assessed at baseline, post-treatment (following 21 weeks of treatment; primary outcome), and three months post treatment completion.
Primary outcome [2] 320444 0
Changes in 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 [2] 320444 0
Assessed at baseline, post-treatment (following 21 weeks of treatment; primary outcome), and three months post treatment completion.
Primary outcome [3] 320445 0
Changes in empathy/guilt, assessed via the Griffith Empathy Measure (GEM; parent-report) and the UNSW Empathy Scale (parent-report).
Timepoint [3] 320445 0
Assessed at baseline, post-treatment (following 21 weeks of treatment; primary outcome), and three months post treatment completion.
Secondary outcome [1] 371618 0
Additional primary outcome:
Changes in parent-child interactions (i.e., child compliance, and parental warmth/affection/responsivity/consistency), assessed via the Dyadic Parent-Child Interaction Coding System, 4th Edition (DPICS-IV) (observational coding system).
Timepoint [1] 371618 0
Assessed at baseline, post-treatment (following 21 weeks of treatment; primary outcome), and three months post treatment completion.
Secondary outcome [2] 371619 0
Changes in global child functioning, assessed via the Children's Global Assessment Scale (CGAS; clinician-rated), the Achenbach System of Empirically-Based Assessment (ASEBA) Child Behaviour Checklist (CBCL; parent-report) and Caregiver-Teacher Report Form (TRF; teacher-report), and the Strengths and Difficulties Questionnaires (SDQ: parent- and teacher-report form).
Timepoint [2] 371619 0
Assessed at baseline, post-treatment (following 21 weeks of treatment), and three months post treatment completion.
Secondary outcome [3] 371620 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] 371620 0
Assessed at baseline, post-treatment (following 21 weeks of treatment), and three months post treatment completion.
Secondary outcome [4] 371621 0
Changes in parenting-related stress, assessed via the Parent Stress Index (PSI; parent-report).
Timepoint [4] 371621 0
Assessed at baseline, post-treatment (following 21 weeks of treatment), and three months post treatment completion.
Secondary outcome [5] 371622 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 [5] 371622 0
Assessed at baseline, post-treatment (following 21 weeks of treatment), and three months post treatment completion.
Secondary outcome [6] 371623 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), (3) treatment barriers (assessed via the Barriers to Treatment Participation Scale), and consumer satisfaction (assessed via the Therapy Attitude Inventory).

This is a composite secondary outcome.
Timepoint [6] 371623 0
During treatment phase, post-treatment (following 21 weeks of treatment), and three months post treatment completion.
Secondary outcome [7] 371624 0
Amount of paraprofessional support in mainstream classroom (assessed using count data of number of hours of support), number of special education or remedial classes required (assessed using count data of number of classes required), and number of referrals for behaviour problems (assessed using count data of number of referrals).

This is a composite secondary outcome.
Timepoint [7] 371624 0
During the course of treatment and during a three-month period from post-treatment to follow-up.

Eligibility
Key inclusion criteria
Inclusion criteria include: (a) 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; and (b) English fluency of the primary participating parent/caregiver as PCIT is heavily language-based. Children with clinically significant conduct problems will be grouped into "conduct problems with normative CU traits" and "conduct problems with elevated CU traits" on the basis of scores from the Inventory of Callous-Unemotional Traits (ICU) and Clinical Assessment of Prosocial Emotions (CAPE). Children rated as presenting with at least two of four CU criteria: (1) lack of remorse or guilt, (2) callous-lack of empathy, (3) unconcerned about performance, and (4) shallow or deficient affect, on the basis of combined parent- and teacher-ratings will be grouped into the "conduct problems with elevated CU traits". The American Psychiatric Association adopted this diagnostic approach in the Diagnostic Statistical Manual for Mental Disorders – Fifth Edition (DSM-5) for identifying clinically impairing levels of CU traits (i.e., more severe and stable conduct disorder). Children with a comorbid diagnosis of ADHD will be permitted to enrol in the study since it is highly comorbid with conduct problems, and this diagnosis was included in previously conducted behavioural interventions with children with co-occurring conduct problems and CU traits.
Minimum age
2 Years
Maximum age
7 Years
Gender
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), who are (b) deaf, or are (c) receiving concurrent psychological treatment for disruptive behaviour problems. Only one eligible child per household will be permitted to enrol: the child with the highest disruptive behaviour problem scores on screening measures.

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)
Sequentially numbered, sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation using randomisation table created by computer software.
Factor: level of conduct problems (moderate [T-score of 60-75 on ECBI Intensity Scale] vs. severe [T-score of greater than or equal to 75 on ECBI Intensity Scale]).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical Analyses:
The effects of treatment on the primary outcomes will be tested using multi-group latent growth curve models (LGCM) for randomised designs in Mplus 7. LGCM is one of the most widely utilised and commonly recommended procedures for evaluating RCTs for several reasons: 1) it allows a comparison of treatment groups in terms of systematic behavioural change across all follow-up assessments (i.e., slope) as well as at specific time points using intercept re-centering; 2) it increases the power to detect between group differences by eliminating measurement error; and 3) full information maximum likelihood estimation (FIML) can be used to estimate trajectories for participants with missing observations which provide unbiased estimates under the assumption the data is missing at random. LGCMs will be specified using three assessment points corresponding with the timing of events for the two groups: pre-treatment (week 0), completion of the CARES sessions or corresponding phone calls (week 21), and 3 months post-treatment (week 32). Within LGCM, it is possible to specify unequal spacing between time points for slope parameter(s). Initially, a series of nested unconditional models will be compared using chi-square difference testing to determine whether linear, quadratic, and cubic growth parameters are needed to adequately model change across treatment. Next, a multi-group model will be used to contrast differences in the intercept representing pre-treatment levels of the outcome and slope parameter(s) representing change following pre-treatment. The former will first be tested to ensure that randomisation resulted in baseline equivalence between groups, and then the latter will be tested to examine whether the groups differ on change across treatment.
Group differences will be tested by first specifying a model in which the parameters are fixed to equivalence between the two groups and then a model where the parameters are freely estimated, with chi-square difference testing for nested models being used to determine whether there are significant differences between groups. Significant group differences on the slope parameters will be probed further by re-centering the intercept and testing for differences at each assessment point following treatment. We will also examine whether there are group differences in treatment fidelity, and session attendance and compliance between PCIT-CU and standard PCIT. If differences are found, these variables will be added as covariates along with the stratification factor of conduct problem severity within the multi-group models to determine whether they can account for the observed differences on the primary study outcomes. Exploratory testing of mediators will be examined using a modified version of the growth model outline above. Specifically, putative mediators measured at post-treatment will be regressed onto treatment group assignment, and slopes representing changes in the outcomes will be regressed onto the putative mediators and treatment group assignment. Pre-treatment scores for the putative mediators will be included in the model as control variables. Indirect effects (i.e., mediation) will tested for significance using bias-corrected bootstrapped confidence intervals. Support for greater efficacy of PCIT-CU relative to standard PCIT for children with co-occurring conduct problems and CU traits will be considered strongest if demonstrated by both a per-protocol analysis and an intent-to-treat analysis.
Power Analysis:
Power for testing treatment group differences using multi-group LGCA was estimated using simulation procedure. We tested power based on an estimated rate of change in the slope that would produce a moderate treatment group difference by post-treatment (Cohen’s d=.50). Although there is no gold standard for what constitutes a clinically meaningful difference in RCTs of psychosocial interventions, this effect size is within the generally accepted range reported in the literature. In other words, effect size differences smaller in magnitude would suggest that matched PCIT treatment provides a fairly insignificant improvement over non-matched treatment. Simulation results indicate that with three time points and a sample slightly smaller than the one proposed (n=150), we would have adequate power (1-B=.85) to detect a moderate effect (d=.50) between two groups at a time. The sample size of 192 was determined by permitting a dropout rate (22%) within the 15-30% range obtained by the UNSW Parent-Child Research Clinics, while balancing feasibility of data collection within time constraints, to achieve the target sample size (N=150) necessary for adequate power.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 26793 0
2170 - Liverpool
Recruitment postcode(s) [2] 26795 0
2560 - Campbelltown
Recruitment postcode(s) [3] 26794 0
2564 - Macquarie Fields
Recruitment postcode(s) [4] 26792 0
2565 - Ingleburn

Funding & Sponsors
Funding source category [1] 303062 0
Charities/Societies/Foundations
Name [1] 303062 0
AMP Foundation
Address [1] 303062 0
GPO Box 4134, Sydney NEW SOUTH WALES 2001
Country [1] 303062 0
Australia
Funding source category [2] 303066 0
Other
Name [2] 303066 0
Ingleburn Public School
Address [2] 303066 0
Cumberland Rd & Oxford Road, Ingleburn NSW 2565
Country [2] 303066 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Eva Kimonis
Address
UNSW Parent-Child Research Clinic
School of Psychology
Mathews Building
University of New South Wales
SYDNEY NSW 2052
Country
Australia
Secondary sponsor category [1] 303048 0
None
Name [1] 303048 0
None
Address [1] 303048 0
None
Country [1] 303048 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303612 0
Human Research Ethics Committee, the University of New South Wales
Ethics committee address [1] 303612 0
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 303612 0
Australia
Date submitted for ethics approval [1] 303612 0
15/02/2017
Approval date [1] 303612 0
28/03/2017
Ethics approval number [1] 303612 0
HC17078

Summary
Brief summary
Children with disruptive behaviour problems represent a heterogeneous group whose difficulties arise from multiple developmental pathways, leading to differential treatment response to traditional evidence-based behavioural interventions. The challenge of treatment non-response is also often compounded by limited accessibility of traditional evidence-based interventions in community settings. The current trial aims to evaluate the acceptability and efficacy of an evidence-based behavioural intervention called Parent-Child Interaction Therapy that is matched to the individual needs of young children with disruptive behaviour problems, delivered in a public school setting. It is hypothesised that families receiving matched intervention will show greater improvement in outcomes of interest at post-intervention and 3-month follow-up than those assigned to non-matched intervention, as well as better engagement with treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94258 0
A/Prof Eva Kimonis
Address 94258 0
UNSW Parent-Child Research Clinic
School of Psychology
Mathews Building
University of New South Wales
Sydney NSW 2052
Country 94258 0
Australia
Phone 94258 0
+61 2 93852323
Fax 94258 0
Email 94258 0
e.kimonis@unsw.edu.au
Contact person for public queries
Name 94259 0
A/Prof Eva Kimonis
Address 94259 0
UNSW Parent-Child Research Clinic
School of Psychology
Mathews Building
University of New South Wales
Sydney NSW 2052
Country 94259 0
Australia
Phone 94259 0
+61 2 93852323
Fax 94259 0
Email 94259 0
e.kimonis@unsw.edu.au
Contact person for scientific queries
Name 94260 0
A/Prof Eva Kimonis
Address 94260 0
UNSW Parent-Child Research Clinic
School of Psychology
Mathews Building
University of New South Wales
Sydney NSW 2052
Country 94260 0
Australia
Phone 94260 0
+61 2 93852323
Fax 94260 0
Email 94260 0
e.kimonis@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants did not consent to release individual participation data.
What supporting documents are/will be available?
No other documents available
Summary results
No Results