Authors
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Professor Eva Kimonis -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2019
INTERVENTION: 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 followi CONDITION: Disruptive Behaviour Disorder;Oppositional Defiant Disorder;Conduct Disorder;Callous‐Unemotional Traits; ; Disruptive Behaviour Disorder ; Oppositional Defiant Disorder ; Conduct Disorder ; Callous‐Unemotional Traits Mental Health ‐ Other mental health disorders SECONDARY OUTCOME: 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.[During treatment phase, post‐treatment (following 21 weeks of treatment), and three months post treatment completion.] 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).[Assessed at baseline, post‐treatment (following 21 weeks of treatment; primary outcome), and three months post treatment completion.] 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). ; PRIMARY OUTCOME: 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).[Assessed at baseline, post‐treatment (following 21 weeks of treatment; primary outcome), and three months post treatment completion.] Changes in empathy/guilt, assessed via the Griffith Empathy Measure (GEM; parent‐report) and the UNSW Empathy Scale (parent‐report).; [Assessed at baseline, post‐treatment (following 21 weeks of treatment; primary outcome), and three months post treatment completion.] 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).; [Assessed at baseline, post‐treatment (following 21 weeks of treatment; primary outcome), and three months post treatment completion.] ; This is a composite secondary outcome.[During the course of treatment and during a three‐month period from post‐treatment to follow‐up.] 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).[Assessed at baseline, post‐treatment (following 21 weeks of treatment), and three months post treatment completion.] 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).[Assessed at baseline, post‐treatment (following 21 weeks of treatment), and three months post treatment completion.] 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).[Assessed at baseline, post‐treatment (following 21 weeks of treatment), and three months post treatment completion.] Changes in parenting‐related stress, assessed via the Parent Stress Index (PSI; parent‐report).[Assessed at baseline, post‐treatment (following 21 weeks of treatment), and three months post treatment completion.] 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 def
Epistemonikos ID: ce3af8ab19d441174c964796322ce42ce7d7f538
First added on: Aug 24, 2024