Testing an Early Intervention Programme for Very Young Children with Emerging Disruptive Behaviour

Not Applicable

• Conditions: Disruptive Behaviour Disorder; Callous-Unemotional Traits; Mental Health - Other mental health disorders

• Registration Number: ACTRN12619000239167
• Lead Sponsor: Associate Professor Jenny Richmond

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-18
• Last Update Posted: 31 January 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Inclusion criteria include: i) Child aged 12-24 months of age; ii) T-score greater than or equal to 60 on the ITSEA Externalising domain; iii) Participating parent/caregiver and child fluent in English, as PCIT is heavily language-based; iv) Participating parent/caregiver and child not deaf or have significant visual impairment.

Exclusion Criteria

Exclusion criteria include: i) Participating parent/caregiver has intellectual disability ii) Child is receiving concurrent psychological treatment for emotional/behavioural problems iii) Child diagnosed with Autism Spectrum Disorder iv) Parent/caregiver has significant mental health problems that are likely to interfere with the treatment engagement v) Active intimate partner/domestic violence where the abusive partner is current residing in the home (risk issue will first be dealt with, before commencing intervention).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in child behavioural difficulties, assessed via the on Infant-Toddler Social and Emotional Assessment (ITSEA) (parent- and childcare provider-report).[Baseline, following week 7 of intervention, and six-months post-intervention completion. ];Changes in psychophysiological responses to emotion (i..e, Callous-Unemotional Trait risk factors), assessed via the dot probe task using eye-tracking equipment.[Baseline, following week 7 of intervention, and six months post-intervention completion. ];Changes in parent-child interactions (i.e., consistency) assessed via the Dyadic Parent-Child Interaction Coding System, 4th Edition (DPICS-IV) (observational coding system)[Baseline, following week 7 of intervention, and six months post-intervention completion. ]

Secondary Outcome Measures

Name	Time	Method
Changes in parenting stress, assessed via Parenting Stress Index 4th Edition Short-Form.<br>[Baseline, following week 7 of intervention, and six months post-intervention completion. ];Acceptability of intervention, assessed via (i) attendance and engagement (i.e., missed sessions, re-scheduled sessions, sessions ended early, homework compliance, and premature drop-out), (ii) intervention fidelity (assessed using session integrity checklist), (iii) intervention barriers (assessed via the Barriers to Treatment Participation Scale) and consumer satisfaction (assessed via the Therapy Attitude Inventory). [Following week 7 of intervention, and six months post-intervention completion. ];Changes in parent wellbeing, assessed via Brief Symptom Inventory. [Baseline, following week 7 of intervention, and six months post-intervention completion. ]