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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

21/07/2024

Date data sharing statement initially provided

9/07/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Improving mental health outcomes through parent and teacher engagement in school-based early intervention

Scientific title

Improving mental health outcomes through parent and teacher engagement in school-based early intervention

Secondary ID [1]

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

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

The primary aim of this research project is to evaluate the acceptability and efficacy of school-based Parent-Child Interaction Therapy (PCIT) early intervention that is matched to the individual needs of young children with conduct problems. A randomised controlled trial will be conducted. Children identified via a screening as eligible for participation in the early intervention program will be will be divided into two groups according to whether or not they present with callous-unemotional (CU) traits. These children and their families will then be randomised to receive one of two interventions: (1) Standard PCIT or (2) PCIT-CU, 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). 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. 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 expressions of enjoyment, while simultaneously withdrawing their attention from attention-seeking 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. 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. 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 [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 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; (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 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). 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 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. 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. 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). 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 targets 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 children's 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, 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.

Teacher participation in PCIT/PCIT-CU:
The caregiver(s) of participating children will be asked to consent children's teaching staff receiving and providing information regarding the student's participation in PCIT. If consent is given, all teaching staff directly involved with the child receiving PCIT (e.g., classroom teacher(s), learning support staff) will be provided the opportunity to access and request support services from the child’s PCIT therapist. At the time of the baseline assessment, one teaching staff will be invited to complete several questionnaires about the student's behaviour at school. After CDI Coach 2, teaching staff will be invited to participate in an upcoming PCIT session in the PCIT clinic and classroom coaching. The in-clinic and in-class behavioural coaching support provided to the child’s teaching staff will follow the guidelines outlined in the PCIT treatment protocols, involving coaching from the child’s PCIT therapist in the application of teacher-student relationship-building skills and behaviour management strategies as the teacher-student dyad engages in play-based activities. Throughout PCIT, teaching staff are encouraged to contact the PCIT therapist to discuss the PCIT strategies, the student's progress in PCIT, and/or the student's behaviour at school via phone or in-person meeting. All preschool, Kindergarten, Year 1, and Year 2 teaching staff at participating schools will be invited to participate in a one-day-equivalent professional learning workshop face-to-face. The newly-developed workshop is focused on providing information about the development of conduct problems and practical experience in evidence-based behaviour management strategies. This workshop will take place during the first two terms of each new school year.

Intervention code [1]

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]

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]

Assessed at baseline, post-treatment (following 21 weeks of treatment; primary outcome), and three months post treatment completion.

Primary outcome [2]

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]

Assessed at baseline, post-treatment (following 21 weeks of treatment; primary outcome), and three months post treatment completion.

Primary outcome [3]

Changes in empathy/guilt, assessed via the Griffith Empathy Measure (GEM; parent-report) and the Measure of Empathy in Early Childhood (MEEC; parent-report).

Timepoint [3]

Assessed at baseline, post-treatment (following 21 weeks of treatment; primary outcome), and three months post treatment completion.

Secondary outcome [1]

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]

Assessed at baseline, post-treatment (following 21 weeks of treatment; primary outcome), and three months post treatment completion.

Secondary outcome [2]

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]

Assessed at baseline, post-treatment (following 21 weeks of treatment), and three months post treatment completion.

Secondary outcome [3]

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]

Assessed at baseline, post-treatment (following 21 weeks of treatment), and three months post treatment completion.

Secondary outcome [4]

Changes in parent psychopathology, assessed via the Parent Stress Index (PSI; parent-report) and Depression Anxiety Stress Scale, short form (DASS-21; parent-report).

Timepoint [4]

Assessed at baseline, post-treatment (following 21 weeks of treatment), and three months post treatment completion.

Secondary outcome [5]

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]

Assessed at baseline, post-treatment (following 21 weeks of treatment), and three months post treatment completion.

Secondary outcome [6]

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]

During treatment phase, post-treatment (following 21 weeks of treatment), and three months post treatment completion.

Secondary outcome [7]

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]

During the course of treatment and during a three-month period from post-treatment to follow-up.

Secondary outcome [8]

Changes in student-teacher relationship quality, assessed via the Student-Teacher Relationship Scale (STRS; teacher-report).

Timepoint [8]

Assessed at baseline, post-treatment (following 21 weeks of treatment), and three months post treatment completion.

Secondary outcome [9]

Changes in the wellbeing of all preschool, Kindergarten, Year 1, and Year 2 students assessed via ASEBA Child Behaviour Checklist (ASEBA CBCL; parent-report).

Timepoint [9]