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Trial registered on ANZCTR


Registration number
ACTRN12619000239167
Ethics application status
Approved
Date submitted
14/02/2019
Date registered
18/02/2019
Date last updated
19/08/2019
Date data sharing statement initially provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing an Early Intervention Programme for Very Young Children with Emerging Disruptive Behaviour
Scientific title
Testing the Feasibility and Acceptability of an Early Intervention Programme, Parent-Child Interaction Therapy, Adapted for Very Young Children (aged 12-23 months) with Emerging Disruptive Behaviour
Secondary ID [1] 297380 0
None.
Universal Trial Number (UTN)
U1111-1228-4085
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disruptive Behaviour Disorder 311531 0
Callous-Unemotional Traits 311532 0
Condition category
Condition code
Mental Health 310168 310168 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participating families will receive a modified version of Parent-Child Interaction Therapy: Callous-Unemotional version (PCIT-CU), adapted to meet the needs of children aged 12 to 23 months with emerging disruptive behaviour.

PCIT-CU 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. Due to the developmental needs of children 12-23 months old, the adapted PCIT-CU intervention under investigation includes the Child-Directed Interaction phase of PCIT-CU (CDI-CU) only. During sessions, parents are coached in traditional play therapy skills, including following the child’s lead and engaging in warm/affectionate and emotionally responsive parenting. Parents are taught to consistently attend to and reinforce positive child behaviours via "do" skills, including praise, descriptions of child behaviour, reflections of appropriate child speech, imitations of appropriate child behaviour, and expressing warm and affectionate behaviours towards the child (e.g., positive touch, increased eye contact), while simultaneously withdrawing their attention from negative, inappropriate behaviours. The overall purpose of applying these skills is to improve the quality of the parent-child relationship, which help promote changes in behaviour.

The first intervention session is a Teach session during which parents are taught specific skills. These skills are then practiced in the following six Coach sessions. The current protocol utilises a fixed approach to dosage, with all families receiving seven weekly, 30-45-minute intervention sessions. Prior research indicates improved outcomes and lower attrition rates using a fixed approach to dosage.

The therapy will be delivered by a provisional, general or clinically registered psychologist trained in the protocol, one-on-one in a research setting.

Parents will be provided handouts designed specifically for this study. These handouts will include the skills taught and age-appropriate toys recommended for 5 minutes of daily practice. Each week, parents will be given homework sheets to complete detailing whether they completed their daily practice, what toys they used, and problems or questions that arose during daily practice.

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] 313643 0
Treatment: Other
Intervention code [2] 313644 0
Behaviour
Comparator / control treatment
None. This is an open trial design.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319079 0
Changes in child behavioural difficulties, assessed via the on Infant-Toddler Social and Emotional Assessment (ITSEA) (parent- and childcare provider-report).
Timepoint [1] 319079 0
Baseline, following week 7 of intervention, and six-months post-intervention completion.
Primary outcome [2] 319080 0
Changes in psychophysiological responses to emotion (i..e, Callous-Unemotional Trait risk factors), assessed via a mimicry task using Electromyography and the dot probe task using eye-tracking equipment.
Timepoint [2] 319080 0
Baseline, following week 7 of intervention, and six months post-intervention completion.
Primary outcome [3] 319081 0
Changes in parent-child interactions (i.e., consistency) assessed via the Dyadic Parent-Child Interaction Coding System, 4th Edition (DPICS-IV) (observational coding system)
Timepoint [3] 319081 0
Baseline, following week 7 of intervention, and six months post-intervention completion.
Secondary outcome [1] 366918 0
Changes in parenting stress, assessed via Parenting Stress Index 4th Edition Short-Form.
Timepoint [1] 366918 0
Baseline, following week 7 of intervention, and six months post-intervention completion.
Secondary outcome [2] 366919 0
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).
Timepoint [2] 366919 0
Following week 7 of intervention, and six months post-intervention completion.
Secondary outcome [3] 366978 0
Parental warmth, assessed using the Warmth and Affection Coding System 2nd Edition (WACS-2) (observational coding system).

Note: This is a Primary Outcome
Timepoint [3] 366978 0
Baseline, following week 7 of intervention, and six months post-intervention completion.
Secondary outcome [4] 366979 0
Changes in parent wellbeing, assessed via Brief Symptom Inventory.
Timepoint [4] 366979 0
Baseline, following week 7 of intervention, and six months post-intervention completion.

Eligibility
Key inclusion criteria
Inclusion criteria include: i) Child aged 12-23 months of age; ii) T-score greater than or equal to 65 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.
Minimum age
12 Months
Maximum age
23 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not Applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not Applicable.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Number of Participants:
This open trial research will involve N=10 families with children aged 12-23 months with emerging disruptive behaviours. PCIT attrition rates for children with clinically significant conduct problems have ranged from 33% to 36%, thus we expect an attrition rate of approximately 35%. Accounting for attrition, a total of 13 families (children and parent/caregiver dyads) will be recruited for the open trial.

Statistical Analyses:
Acceptability of the intervention will be tested using descriptive analyses to examine mean scores on the resolved treatment satisfaction measure at follow-up assessments, average rates of session attendance and homework completion across treatment, and the participant dropout rate.
The preliminary efficacy of the intervention will be tested by examining change in primary outcomes during and post-intervention using linear mixed models.
To test for clinically significant differences, Cohen's d effect size differences between pre- and post-scores for primary outcomes will be examined.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301950 0
University
Name [1] 301950 0
University of New South Wales
Address [1] 301950 0
University of New South Wales
SYDNEY NSW 2052
Country [1] 301950 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Eva Kimonis
Address
UNSW Parent-Child Research Clinic
School of Psychology
Mathews Building
University of New South Wales
SYDNEY NSW 2052
Country
Australia
Secondary sponsor category [1] 301707 0
Individual
Name [1] 301707 0
Dr Jenny Richmond
Address [1] 301707 0
University of New South Wales
School of Psychology
SYDNEY NSW 2052
Country [1] 301707 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302631 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 302631 0
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 302631 0
Australia
Date submitted for ethics approval [1] 302631 0
18/02/2019
Approval date [1] 302631 0
13/03/2019
Ethics approval number [1] 302631 0

Summary
Brief summary
This project is a pilot study aiming to examine the initial feasibility, acceptability and preliminary efficacy of a seven-week early intervention programme among a sample of very young children with emerging disruptive behaviours and their families.

The empirically-supported PCIT-CU protocol will be adapted to meet the needs of 12-23-month old children. In particular, the intervention under investigation involves an initial parent-only session, which focuses on teaching parents how to positively engage with their child. Parent(s) and children will then attend six-weekly 30-45-minute sessions, in which parents receive in-vivo coaching from a clinician using skills taught in the initial session, using a wireless headset from behind a one-way mirror. Parents will then be asked to complete daily 5-minute skills practice activities involving playtime with their child at home.

It is hypothesized that families will show improvement in the primary outcomes at post-treatment and 6-month follow-up. Primary outcome measures include improvements in child disruptive behaviours, precursor markers of callous-unemotional (CU) behaviours (e.g., lack of empathy/ guilt, uncaring attitudes/behaviours), and parental stress and wellbeing.
Trial website
http://www.conductproblems.com/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90882 0
A/Prof Eva Kimonis
Address 90882 0
UNSW Parent-Child Research Clinic
School of Psychology
Mathews Building
University of New South Wales
Sydney NSW 2052
Country 90882 0
Australia
Phone 90882 0
+61 2 93852323
Fax 90882 0
Email 90882 0
e.kimonis@unsw.edu.au
Contact person for public queries
Name 90883 0
Dr Ariana Krynen
Address 90883 0
UNSW Parent-Child Research Clinic
School of Psychology
Mathews Building
University of New South Wales
Sydney NSW 2052
Country 90883 0
Australia
Phone 90883 0
+61 2 9385 0376
Fax 90883 0
Email 90883 0
a.krynen@unsw.edu.au
Contact person for scientific queries
Name 90884 0
Dr Ariana Krynen
Address 90884 0
UNSW Parent-Child Research Clinic
School of Psychology
Mathews Building
University of New South Wales
Sydney NSW 2052
Country 90884 0
Australia
Phone 90884 0
+61 2 9385 0376
Fax 90884 0
Email 90884 0
a.krynen@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants did not consent to the release of individual participant data.
What supporting documents are/will be available?
No other documents available
Summary results
No Results