None listed
Conditions
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.
Interventions
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).
Sponsors
Study design
Eligibility
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.
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.