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Trial registered on ANZCTR


Registration number
ACTRN12616000221459
Ethics application status
Approved
Date submitted
16/02/2016
Date registered
18/02/2016
Date last updated
28/02/2020
Date data sharing statement initially provided
29/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing telemethods to expand the availability of Parent-Child Interaction Therapy (PCIT) for disruptive young children
Scientific title
A non-inferiority trial of Internet-delivered Parent-Child Interaction Therapy (I-PCIT) to reduce the disruptive behaviour of young children
Secondary ID [1] 288557 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oppositional Defiant Disorder 297669 0
Conduct Disorder 297670 0
Condition category
Condition code
Mental Health 297851 297851 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participating families will be randomly allocated to either standard, in-clinic Parent-Child Interaction Therapy (PCIT) or Internet-delivered Parent-Child Interaction Therapy.

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 praise, descriptions, reflections, and imitations, 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 6 coaching 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 in total (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 therapy will be delivered by a therapist certified in PCIT, one-on-one in a research clinic setting.

I-PCIT:
I-PCIT is an Internet-delivered format of PCIT, drawing on real-time, interactive technology. Unlike standard PCIT, I-PCIT uses real-time videoconferencing for sessions, delivering live coaching to parents wearing cordless headsets to afford mobility to provide live and evidence-based coaching of parent-child interactions directly to a family’s home setting. Although the delivery format differs from standard PCIT, the contents of I-PCIT directly follow the standard protocol, with the minor exception that the initial session also includes an introduction to technological aspects of treatment. To maintain relative control of the in-home setting during treatment, parents are told their appointment should be treated just as any in-clinic appointment (e.g., direct phones to voicemail) and pets should be locked in other rooms. During sessions, I-PCIT families broadcast parent-child interactions live from their home via webcam over an encrypted connection, and therapists provide instantaneous feedback from a remote site to a wireless headset worn by the parent. Also, whereas handouts are given in standard PCIT after sessions throughout treatment, I-PCIT session handouts are made available online and only for the session in which the principles are introduced. As in the standard PCIT protocol, I-PCIT 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). The therapy will be delivered by a therapist certified in PCIT, one-on-one, with the therapist situated at the research clinic and the family situated in their own home.

Adherence to the protocol will be monitored via the number of sessions that participating families attend and adherence to homework requirements (i.e., five minutes of daily skill practice).
Intervention code [1] 293937 0
Treatment: Other
Intervention code [2] 293947 0
Behaviour
Comparator / control treatment
This study involves an active control condition. The intervention (Internet-delivered PCIT) will be compared against standard, in-clinic Parent-Child Interaction Therapy (PCIT), whereby participating families will receive 14 weekly, one-hour treatment sessions in a one-on-one, face-to-face format, delivered in a research clinic setting by a therapist certified in PCIT.
Control group
Active

Outcomes
Primary outcome [1] 297378 0
Changes in child diagnostic status (assessed via the Diagnostic Interview Schedule for Children, Adolescents and Parents [DISCAP]).
Timepoint [1] 297378 0
Baseline, following week 7 of treatment, following week 14 of treatment, and three months post treatment completion.
Primary outcome [2] 297379 0
Changes in child behavioural symptoms (assessed via the Eyberg Child Behaviour Inventory [ECBI]).
Timepoint [2] 297379 0
Baseline, following week 7 of treatment, following week 14 of treatment, and three months post treatment completion.
Primary outcome [3] 297391 0
Changes in child functioning (assessed via the Children's Global Assessment Scale [CGAS] and the Clinical Global Impression - Severity and Improvement Scales [CGI-S and -I]).
Timepoint [3] 297391 0
Baseline, following week 7 of treatment, following week 14 of treatment, and three months post treatment completion.
Secondary outcome [1] 320884 0
Additional primary outcome:
Changes in parent-child interactions (assessed via the Dyadic Parent-Child Interaction Coding System, 3rd Edition [DPICS-III]).
Timepoint [1] 320884 0
Baseline, following week 7 of treatment, following week 14 of treatment, and three months post treatment completion.
Secondary outcome [2] 320950 0
Acceptability of intervention (assessed via attendance and engagement [i.e., missed sessions, re-scheduled sessions, sessions ended early, homework compliance, and premature drop-out], treatment fidelity, treatment barriers [via the Barriers to Treatment Participation Scale], and consumer satisfaction [via the Therapy Attitude Inventory]).

This is a composite secondary outcome.
Timepoint [2] 320950 0
Following week 7 of treatment, following week 14 of treatment, and three months post treatment completion.

Eligibility
Key inclusion criteria
Inclusion criteria include: (i) children (aged 2-7 years) meeting diagnostic criteria for DSM-5 principal Oppositional Defiant Disorder or Conduct Disorder, with at least one primary caretaker fluent in English, (ii) Eyberg Child Behavior Inventory (ECBI) Intensity Scale score in the clinical range (>132), (iii) English-speaking (child and caretaker), (iv) family-home equipped with broadband connection and computer equipped with Pentium (or compatible) processor, 128 MB RAM, 200 MB available of hard disk space, 16-bit colour display adapter, and USB port.
Minimum age
2 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include: (i) presence of child emotional/behaviour problem more impairing than DBD, (ii) parent or child score <75 on IQ screening, (iii) history of severe physical or mental impairments (e.g., deafness, blindness) in child or primary caretaker(s).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered, sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation using randomisation table created by computer software.
Factors: (i) level of conduct problems (moderate [t-score of 60-75 on ECBI Intensity Scale] vs. severe [t-score of greater than or equal to 75 on ECBI Intensity Scale]), and (ii) level of callous-unemotional traits (low CU traits [less than 2 items endorsed on Inventory of Callous-Unemotional Traits (ICU)] vs. high CU traits [equal to or greater than 2 items endorsed on ICU]).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Non-inferiority trial comparing standard PCIT to Internet-delivered PCIT.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To assess the non-inferiority of I-PCIT compared to standard PCIT, the two-sided 95% confidence interval of the difference between the two interventions will be computed. Non-inferiority will be concluded at the 2.5% level if the lower bound of the confidence interval falls above a pre-specified level on the primary outcome measure of child behavioural symptoms. Specifically, a non-inferiority margin of 15 points on the ECBI Intensity scale is to be used to determine non-inferiority. This corresponds to an effect size of d=.33, which was determined the smallest difference between the two treatments that would be considered clinically meaningful.

Multilevel models will be used to examine group means over time in the continuous, normally-distributed outcomes. The mean difference between the groups and 95%CI at the post-intervention measurement will be obtained and non-inferiority will then be assessed.

All analyses will be conducted using both intent-to-treat and per-protocol approaches, as per the recommendation outlined in both ICH E10 and CONSORT guidelines. The intent-to-treat analysis will include the data of all participants randomised into groups, regardless of actual participation in treatment. In contrast, the per-protocol analysis will only include participants who comply with the protocol (i.e., complete treatment). The most rigorous approach is to use both analyses, with the strongest results obtained when non-inferiority is demonstrated in both populations of participants. Analyses will be performed in Stata/SE 13.1 or SAS 9.4 software.

Power Analysis: For power of 80% and alpha=0.05, 88 in each group would be required in order to show non-inferiority of I-PCIT on the ECBI primary outcome measure, assuming a common SD of 40 and that a mean difference greater than 15 points is unacceptable (d=.33). Analyses were run using Stata/SE 13.1.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
16/02/2016
Date of last participant enrolment
Anticipated
31/01/2019
Actual
31/01/2019
Date of last data collection
Anticipated
31/01/2021
Actual
Sample size
Target
176
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5288 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 5289 0
Karitane - Carramar
Recruitment postcode(s) [1] 12746 0
2145 - Westmead
Recruitment postcode(s) [2] 12747 0
2163 - Carramar

Funding & Sponsors
Funding source category [1] 292904 0
University
Name [1] 292904 0
University of New South Wales
Country [1] 292904 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] 291650 0
Individual
Name [1] 291650 0
Suzanne Benson
Address [1] 291650 0
The Children's Hospital at Westmead
Locked Bag 4001
WESTMEAD NSW 2145
Country [1] 291650 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294404 0
Human Research Ethics Committee, the University of New South Wales
Ethics committee address [1] 294404 0
Ethics committee country [1] 294404 0
Australia
Date submitted for ethics approval [1] 294404 0
09/03/2015
Approval date [1] 294404 0
10/03/2015
Ethics approval number [1] 294404 0
HC14297

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 768 768 0 0
/AnzctrAttachments/370137-UNSW HREC Letter of Ethics Approval - I-PCIT (HC14297).pdf

Contacts
Principal investigator
Name 63606 0
A/Prof Eva Kimonis
Address 63606 0
UNSW Parent-Child Research Clinic
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 63606 0
Australia
Phone 63606 0
+61 2 93852323
Fax 63606 0
Email 63606 0
[email protected]
Contact person for public queries
Name 63607 0
Eva Kimonis
Address 63607 0
UNSW Parent-Child Research Clinic
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 63607 0
Australia
Phone 63607 0
+61 2 93852323
Fax 63607 0
Email 63607 0
[email protected]
Contact person for scientific queries
Name 63608 0
Eva Kimonis
Address 63608 0
UNSW Parent-Child Research Clinic
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 63608 0
Australia
Phone 63608 0
+61 2 93852323
Fax 63608 0
Email 63608 0
[email protected]

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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.