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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

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Disruptive Behaviour Disorder

Oppositional Defiant Disorder

Conduct Disorder

Callous-Unemotional Traits

Condition category

Condition code

Mental Health

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]

Treatment: Other

Intervention code [2]

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]

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]