Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000798763
Ethics application status
Approved
Date submitted
16/07/2013
Date registered
17/07/2013
Date last updated
26/07/2019
Date data sharing statement initially provided
26/07/2019
Date results information initially provided
26/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Parent Whispering - the art of empowering parents to change, to improve their child's behaviour. A study looking at the feasibility and utility of delivering Parent-Child Interaction Therapy (PCIT) to vulnerable New Zealand families in two real world settings (community and residential).
Scientific title
A study looking at the feasibility and utility of delivering Parent-Child Interaction Therapy (PCIT) to vulnerable New Zealand families in two real world settings (community and residential).
Secondary ID [1] 281943 0
None
Universal Trial Number (UTN)
u1111-1139-4789
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disruptive behaviour disorder 288353 0
Parenting 288354 0
Child welfare 288355 0
Mental Health 288356 0
Trauma 289608 0
Condition category
Condition code
Mental Health 288706 288706 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parent-child interaction therapy (PCIT). PCIT is a family-behavioural treatment for parent-child dyads, where the young child (2-7years of age) has severe behaviour problems and/or there are serious concerns regarding parenting. Parents and their child attend weekly therapy sessions (45-60 minutes in length) and commit to 5 minute therapy homework (recorded daily).
The PCIT therapist coaches the parent (from behind a one-way screen using a transmitting and receiving device), during live parent-child interactions.
PCIT is a manualised programme where parents complete weekly rating scales to monitor their child's behaviour (self-report), homework compliance (self-report) and the parent-child relationship (assessed by the therapist using a standardised coding sheet). To ensure treatment integrity, the therapist completes weekly session integrity checklists, video-tapes sessions, and attends monthly PCIT supervision. Additionally a random selection of videotaped sessions will be assessed by an external PCIT supervisor, to ensure inter-rater reliability of 80%.
PCIT has two phases of treatment. Child Directed Interaction (CDI), where the parent learns to follow their child's lead during play and how to use the positive PRIDE skills of giving labelled Praise, Reflecting appropriate language, Imitating play sequences, Describing how their child plays and showing Enjoyment when they are with their child. They also learn to refrain from using questions, commands and negative talk during interactions with their child. Any annoying or obnoxious behaviour is handled with active ignoring and positive redirecting and play stops for any dangerous and destructive play. During CDI the relationship develops warmth and the interactions become more positive. In order to master this phase of treatment and move on to phase two,the parent must give 10 Labelled Praises, 10 Behavioural Descriptions, 10 Reflections of language, and use no more than 3 questions, commands or negative talk, in a 5 minute play sequence. The child's behaviour must have improved and their play become more organised according to the parental reports and therapist observations.
In the second phase of treatment, Parent Directed Interaction (PDI), the parent learns to give good commands, set limits and boundaries and a sensitive discipline process to handle non-compliance. The child learns to listen and make good choices. Mastery criteria for PDI is when the parent can give 4 positively stated commands (using the correct process 75% of the time) and the child is able to comply 75% of the time. Therapy does not stop until master criteria is reached and the child's behaviour ratings has fallen well below normal limits according to the Eyberg Child Behavioural Inventory (ECBI) i.e a total score of 115 or below.
For this study, collation of data will stop after 12 sessions of therapy.
Intervention code [1] 286506 0
Behaviour
Comparator / control treatment
None - this is a single group study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288848 0
Eyberg Child Behaviour Inventory (ECBI) is a measure of child behaviour (2-16years). A score of 131 and above is considered within the clinical range.
Timepoint [1] 288848 0
The ECBI is measured weekly and allows an opportunity to show incremental changes. It will also be measured at 3month follow-up.
Primary outcome [2] 288849 0
Dyadic Parent-Child Interaction Coding Sheet -III (DPICS-III). This is a behavioural coding system that measures the quality of parent-child social interactions used specifically for PCIT. An abbreviated coding manual (DPICS-A) is used by all PCIT therapist and requires 80% inter-rater reliability for competency.
Timepoint [2] 288849 0
The DPICS -III is completed on a weekly basis allowing both parent and child mastery criteria to be assessed. It will also be measured at 3month follow-up.
Secondary outcome [1] 301141 0
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): This is a brief screening questionnaire to find out about peoples use of psychoactive substances. It was developed by the World Health Organisation (WHO). It is designed to be used by healthcare workers to help identify potential substance use problems.
Timepoint [1] 301141 0
Completed at pre and post treatment and at 3 month follow-up
Secondary outcome [2] 301142 0
Ages and Stages Questionnaire: Social Emotional (ASQ: SE): This is completed by the study participant about their child/ren. There are different forms depending on the age of the child, reflecting their developmental period. There are between 22–36 questions with, most of the time, sometimes, and rarely or never as the range of answers available. Each questionnaire addresses seven crucial behavioural areas: self-regulation, compliance, communication, adaptive functioning, autonomy, affect, and interaction with people.
Timepoint [2] 301142 0
Completed pre and post treatment and at 3 month follow-up
Secondary outcome [3] 301143 0
Ages and Stages Questionnaire –Third Edition (ASQ-3): This is completed by the study participant about their child/ren. It consists of 30 questions which assist in determining a young child's progress in each developmental area and whether there are any developmental delays.
Timepoint [3] 301143 0
Completed at pre and post treatment and at 3 month follow-up
Secondary outcome [4] 301144 0
Child Abuse Potential Inventory (CAP): The CAP Inventory is a screening tool for physical child abuse. It is a 160-item self-report given to the parent/caregiver.
Timepoint [4] 301144 0
Completed pre and post treatment and at 3 month follow-up.
Secondary outcome [5] 301145 0
Parenting Stress Index (PSI/SF) Short form. PSI is a parent self-report, for parents with children under 12yrs of age. Has a total stress score from 3 scales Parental DIstress, Parent-Child dysfunctional interaction and Difficult Child.
Timepoint [5] 301145 0
Completed at pre and post treatment and at 3 month follow-up.
Secondary outcome [6] 301146 0
Therapy Attitude Inventory (TAI): The TAI is a parent-report scale of satisfaction with the process and outcome of therapy.
Timepoint [6] 301146 0
Completed post treatment and at 3 month follow-up.
Secondary outcome [7] 301355 0
Emotional Availability Scales (EA) Scales. The EA Scales are designed to measure the quality of the emotional relationship between the parent and child.
Timepoint [7] 301355 0
Completed at pre and post treatment and at 3 month follow-up

Eligibility
Key inclusion criteria
Participants must attend Merivale or Whakatupu Ora, and:
Be parents/caregivers of toddlers (aged between 2-4 years of age), with significant behavioural and/or relational difficulties. Or there must be serious concerns regarding lack of parenting skill or neglect.
The toddlers must be residing predominantly with the parent/caregiver.
Parents must be over the age of 16 years of age and be able to provide written and informed consent.
Parents must speak English.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The parents had a current acute serious psychiatric illness and/or severe problems with alcohol/substance abuse (e.g. currently in detoxification programme).
The parent or their child had significant intellectual disability.
The parent or their child has ASD.

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)
This is an open clinical trial set in real-world clinical settings, so only those people referred to the setting, who give consent will be included in the study. This is not a randomised trial, but a feasibility study. The results will be used to conduct a larger controlled trial. There will be no control group, thus no concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Real-world trial, in real world clinical settings. Thus only those referred participants who give consent will be included in the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will compare pre and post treatment levels of child behaviour using the ECBI as the primary outcome measure. The ECBI is completed on a weekly basis during treatment, so we are able to measure incremental improvement. Adjusted differences and 95% confidence intervals will be generated to summarise programme effects. Linear Mixed Models (LMM) analysis will be performed on maternal outcome data to investigate time and participant effects. In the LMM model, the clinical measure will be set as the dependent variable, time as a fixed factor, and participant as a random factor. Pair wise comparisons will be conducted to further investigate the time effect (i.e. whether the change occurred between baseline and post-intervention or between post-intervention and follow-up point).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2013
Actual
1/08/2013
Date of last participant enrolment
Anticipated
30/04/2014
Actual
30/03/2014
Date of last data collection
Anticipated
Actual
30/06/2014
Sample size
Target
40
Accrual to date
Final
42
Recruitment outside Australia
Country [1] 4894 0
New Zealand
State/province [1] 4894 0
Auckland

Funding & Sponsors
Funding source category [1] 286829 0
Self funded/Unfunded
Name [1] 286829 0
Tania Cargo
Country [1] 286829 0
New Zealand
Primary sponsor type
Individual
Name
Tania Cargo
Address
51 Bay st
Red Beach
Orewa 0932
Hibiscus Coast
New Zealand
Country
New Zealand
Secondary sponsor category [1] 285619 0
University
Name [1] 285619 0
The Department of Psychological Medicine
University of Auckland.
Address [1] 285619 0
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country [1] 285619 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288894 0
Health and Disabilities Ethics Committees
Ethics committee address [1] 288894 0
Ministry of Health
New Zealand Government
1 The Terrace
PO BOX 5013
Wellington 6011
Ethics committee country [1] 288894 0
New Zealand
Date submitted for ethics approval [1] 288894 0
30/03/2013
Approval date [1] 288894 0
04/06/2013
Ethics approval number [1] 288894 0
13/CEN/68

Summary
Brief summary
This is a study looking at the feasibility and utility of delivering Parent-Child Interaction Therapy (PCIT) to vulnerable New Zealand families in two real world settings, an Infant Mental Health service (where the children and or their parents have mental health issues) and a residential parenting service for mothers and their children (who are under the care of Child Youth and Family). We will explore whether PCIT is acceptable and useful as a therapy for these two vulnerable communities. We will also explore whether the outcomes reported in large scale randomised control trials can be replicated in the real-world. The findings will then be used to inform the design of a large-scale RCT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37802 0
Mrs Tania Cargo
Address 37802 0
51 Bay St
Red Beach
Orewa 0932
Hibiscus Coast
Country 37802 0
New Zealand
Phone 37802 0
+6494269200
Fax 37802 0
Email 37802 0
[email protected]
Contact person for public queries
Name 37803 0
Mrs Tania Cargo
Address 37803 0
51 Bay St
Red Beach
Orewa 0932
Hibiscus Coast
Country 37803 0
New Zealand
Phone 37803 0
+6494269200
Fax 37803 0
Email 37803 0
[email protected]
Contact person for scientific queries
Name 37804 0
Mrs Tania Cargo
Address 37804 0
51 Bay St
Red Beach
Orewa 0932
Hibiscus Coast
Country 37804 0
New Zealand
Phone 37804 0
+6494269200
Fax 37804 0
Email 37804 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
This research was completed already and not shared on a database


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.