Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000280404
Ethics application status
Approved
Date submitted
2/03/2016
Date registered
3/03/2016
Date last updated
28/02/2020
Date data sharing statement initially provided
18/01/2019
Date results information initially provided
28/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Parent-Child Interaction Therapy for Treating Preschool Conduct Problems
Scientific title
Testing an adapted evidence-based parent training intervention for treatment-resistant conduct problems in young children
Secondary ID [1] 288678 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disruptive Behaviour Disorder 297885 0
Oppositional Defiant Disorder 297886 0
Conduct Disorder 297887 0
Callous-Unemotional Traits 297888 0
Condition category
Condition code
Mental Health 298054 298054 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.

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 four "do" skills, including praise, descriptions of child behaviour, reflections of appropriate child speech, and imitations of appropriate child behaviour, 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. Since transition between phases and to graduation from treatment depends on parents reaching a prescribed level of the phase-specific skills (‘mastery criteria’), the dosage of treatment varies between families. 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). The families 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), meaning that families allocated to standard PCIT will receive a total of 21 sessions delivered weekly. The therapy will be delivered by a therapist certified in standard PCIT, one-on-one in a research or community clinic setting.

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 (CARES; Coaching and Rewarding Emotional Skills) that intensively targets their 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. 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. Six CDI coaching sessions follow in 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 to punish child noncompliance and other problem behaviours are maintained, but the latter de-emphasised. PDI-CU begins with a Teach session educating parents on effective commands and the importance of reward-based strategies with CP+CU children. 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. 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 CP+CU children 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;36 (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 CP+CU children 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 Teach session and six CDI Coach sessions, and one PDI Teach sessions and six PDI 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 sessions delivered weekly. The therapy will be delivered by a therapist certified in standard PCIT and trained in the adapted protocol, one-on-one in a research or community clinic setting. 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 protocol will be monitored via the number of sessions that participating families attend and adherence to session and homework demands/requirements (i.e., five minutes of daily skill practice).
Intervention code [1] 294098 0
Treatment: Other
Intervention code [2] 294099 0
Behaviour
Comparator / control treatment
This study involves an active control condition. The intervention (PCIT-CU) will be compared against standard, in-clinic Parent-Child Interaction Therapy (PCIT), whereby participating families will receive 14 weekly, one-hour treatment sessions plus an additional seven telephone consultations in a one-on-one, face-to-face format, delivered in a research or community clinic setting by a therapist certified in PCIT.
Control group
Active

Outcomes
Primary outcome [1] 297574 0
Changes in child conduct problems, assessed via the Eyberg Child Behaviour Inventory (ECBI) (parent-report) and the Student Behavior Inventory-Revised (SESBI-R) (teacher-report).
Timepoint [1] 297574 0
Baseline, following week 7 of treatment, following week 14 of treatment, following week 21 of treatment, and three months post treatment completion.
Primary outcome [2] 297575 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] 297575 0
Baseline, following week 7 of treatment, following week 14 of treatment, following week 21 of treatment, and three months post treatment completion.
Primary outcome [3] 297577 0
Changes in empathy/guilt, assessed via the Griffith Empathy Measure (GEM) (parent-report).
Timepoint [3] 297577 0
Baseline, following week 7 of treatment, following week 14 of treatment, following week 21 of treatment, and three months post treatment completion.
Secondary outcome [1] 321424 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, 3rd Edition (DPICS-III) (observational coding system).
Timepoint [1] 321424 0
Baseline, following week 7 of treatment, following week 14 of treatment, following week 21 of treatment, and three months post treatment completion.
Secondary outcome [2] 321425 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, (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 [2] 321425 0
Baseline, following week 7 of treatment, following week 14 of treatment, following week 21 of treatment, and three months post treatment completion.
Secondary outcome [3] 321426 0
Changes in child sensitivity to distress cues, assessed via Emotional Pictures Dot-Probe task/ Emotion Recognition task (Preschool versions) (child laboratory task).
Timepoint [3] 321426 0
Baseline, following week 7 of treatment, following week 14 of treatment, following week 21 of treatment, and three months post treatment completion.

Eligibility
Key inclusion criteria
Inclusion criteria include: (a) a score in the clinically significant range (T-scores greater than 70) on at least one of the following disruptive behaviour problem scales: aggressive behaviour, rule breaking, DSM ODD or conduct problems, or externalising composite, (b) endorsement of at least two of four CU criteria across the ICU and CAPE: (1) lack of remorse or guilt, (2) callous-lack of empathy, (3) unconcerned about performance, and (4) shallow or deficient affect, as indicated by a rating of “2” (very true) or “3” (definitely true) on the respective item, (c) at least one parent fluent in English, and (d) children with a comorbid diagnosis of ADHD.
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include: children (a) with a primary mental health diagnosis other than oppositional defiant disorder or conduct disorder (e.g., moderate/severe autism spectrum, intellectual disability), (b) who score greater than 70 on the Receptive Vocabulary subtest of the Wechsler Preschool and Primary Scale of Intelligence-Third Edition (WPPSI-III) administered at baseline, (c) who are deaf, or (d) are receiving concurrent psychological treatment.

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 five assessment points corresponding with the timing of events for the PCIT-CU group: pre-treatment (week 0), completion of CDI (week 7), completion of PDI (week 14), post-CARES (week 20), and 3 months post-treatment (week 32). Within LGCM it is possible to specify unequal spacing between time points for slope parameter(s). The same assessment intervals will be used for participants assigned to standard PCIT to ensure equivalence in the parameterisation of the LGCM across all subjects. 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 mid-treatment or 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 CP+CU children 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 procedures. Power was tested 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 PCIT-CU provides a fairly insignificant improvement over standard PCIT. Simulation results indicate that with five time points and a sample slightly smaller than the one proposed (n=100), we would have adequate power (1-B=.85) to detect a moderate effect (d=.50) between the two groups. The sample size of 128 was determined by permitting a dropout rate (22%) within the 15-30% range obtained by the UNSW child research clinics, while balancing feasibility of data collection within time constraints, to achieve the target sample size (N=100) necessary for adequate power.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
29/01/2016
Date of last participant enrolment
Anticipated
31/12/2019
Actual
31/12/2019
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
128
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5384 0
Karitane - Carramar
Recruitment postcode(s) [1] 12836 0
2163 - Carramar

Funding & Sponsors
Funding source category [1] 293038 0
University
Name [1] 293038 0
University of New South Wales
Country [1] 293038 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] 291814 0
None
Name [1] 291814 0
Address [1] 291814 0
Country [1] 291814 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294549 0
Human Research Ethics Committee, the University of New South Wales
Ethics committee address [1] 294549 0
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 294549 0
Australia
Date submitted for ethics approval [1] 294549 0
04/05/2013
Approval date [1] 294549 0
10/09/2013
Ethics approval number [1] 294549 0
HC13234

Summary
Brief summary
Conduct problems are the most common reason children are referred for mental health treatment, and each child with conduct problems incurs a lifetime public service cost more than eight times greater than that for a healthy child. The presence of callous-unemotional (CU) traits (e.g., lack of empathy/guilt, uncaring attitudes) designates an important subgroup of children whose severe, stable, and aggressive conduct problems are developmental precursors to psychopathy and antisocial behaviour in adulthood. Consequently, CU traits were added as a specifier (called ‘with limited prosocial emotions’) to the diagnosis of conduct disorder in the fifth revision of the Diagnostic and Statistical Manual of Mental Disorders. Between 50-70% of Australian children with diagnosable conduct problems show clinically significant levels of CU traits ('CP+CU children’). Given that treatment for adult psychopathy does not significantly reduce crime and violence, early intervention with at-risk children is vital. However, the conduct problems of CP+CU children are resistant to many traditional evidence-based behavioural interventions that are effective for children without CU traits (‘CP only children’). The reason for this resistance to treatment appears to be that the conduct problems of children with CU traits arise from distinct factors from those typically targeted in traditional interventions. While the field has developed a better understanding of the unique deficits and needs of CP+CU children, interventions that comprehensively target them have not yet been systematically developed and tested.
In order to improve the clinical outcomes of these particularly high risk (CP+CU) children, a major shift in clinical practice paradigms is needed. We propose testing the efficacy of a novel intervention to improve emotional and behavioural outcomes in young CP+CU children. Through pilot testing, an adaptation of Parent-Child Interaction Therapy (PCIT), a traditional evidence-based model of parent management training (PMT) intervention, has developed and refined. PCIT-CU, as it is known, addresses the distinct temperamental deficits of CP+CU children—reward dominance, and insensitivity to distress cues and punishment. PCIT-CU differs from standard PCIT in three key ways: it (a) trains parents to engage in warm, emotionally responsive parenting that improves conscience development among temperamentally fearless children, (b) systematically supplements punishment-based parenting strategies (i.e., time out) with reward-based techniques shown to improve treatment outcomes for reward-dominant CP+CU children, and (c) delivers emotional skill-building instruction to CP+CU children to target their distinct emotional deficits. Given the significant societal burden of this seriously impaired and treatment-resistant subpopulation of children, outcomes associated with the project have the potential to yield impactful and far-reaching clinical and public health benefits.
Trial website
http://www.conductproblems.com/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64030 0
A/Prof Eva Kimonis
Address 64030 0
UNSW Parent-Child Research Clinic
School of Psychology
Mathews Building
University of New South Wales
Sydney NSW 2052
Country 64030 0
Australia
Phone 64030 0
+61 2 93852323
Fax 64030 0
Email 64030 0
[email protected]
Contact person for public queries
Name 64031 0
A/Prof Eva Kimonis
Address 64031 0
UNSW Parent-Child Research Clinic
School of Psychology
Mathews Building
University of New South Wales
Sydney NSW 2052
Country 64031 0
Australia
Phone 64031 0
+61 2 93852323
Fax 64031 0
Email 64031 0
[email protected]
Contact person for scientific queries
Name 64032 0
A/Prof Eva Kimonis
Address 64032 0
UNSW Parent-Child Research Clinic
School of Psychology
Mathews Building
University of New South Wales
Sydney NSW 2052
Country 64032 0
Australia
Phone 64032 0
+61 2 93852323
Fax 64032 0
Email 64032 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
Participants did not consent to release individual participation data.


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
SourceTitleYear of PublicationDOI
EmbaseParent Training Adapted to the Needs of Children With Callous-Unemotional Traits: A Randomized Controlled Trial.2022https://dx.doi.org/10.1016/j.beth.2022.07.001
N.B. These documents automatically identified may not have been verified by the study sponsor.