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Trial registered on ANZCTR


Registration number
ACTRN12618001554257
Ethics application status
Approved
Date submitted
13/09/2018
Date registered
17/09/2018
Date last updated
24/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Karitane ‘My Toddler and Me' study: A Randomised Controlled Trial comparing Parent-Child Interaction Therapy with Toddlers (PCIT-T), Circle of Security-Parenting (COS-P) and Waitlist controls in the treatment of disruptive behaviours in children aged 14-24 months
Scientific title
The Karitane ‘My Toddler and Me' study:
A Randomised Controlled Trial comparing Parent-Child Interaction Therapy with Toddlers (PCIT-T), Circle of Security-Parenting (COS-P) and Waitlist controls in the treatment of disruptive behaviours in children aged 14-24 months
Secondary ID [1] 295522 0
None
Universal Trial Number (UTN)
U1111-1218-1041
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
childhood behavioural problems 309010 0
Condition category
Condition code
Mental Health 307910 307910 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ARM 1

Parent-Child Interaction Therapy – Toddler (PCIT-T) will be delivered according the protocol outlined by Girard, Wallace, Kohlhoff, Morgan & McNeil, 2018. This will include direct live parent coaching (from behind a one-way mirror using a blue tooth headset) during parent-child play sessions. The program will comprise two phases, Child Directed Interaction - Toddler (CDI-T) and Parent Directed Interaction - Toddler (PDI-T).

The CDI-T phase aims to improve the quality of the parent-child relationship by increasing parents’ use of ‘P-R-I-D-E’ skills (with each letter of the word 'PRIDE' representing the following skills: Labeled praise, Reflections of child verbalisations, Imitating child play, Behavioral descriptions, and Enjoyment), decreasing parents’ use of ‘Don’t skills (avoiding questions, commands and criticisms) and utilisation of ‘C-A-R-E-S’ techniques to help the child regulate emotions when needed (with each letter of the word 'CARES' representing the following skills: Coming in close, Assisting the child, Reassuring the child, Labeling the Emotion, Soothing the child). The PDI-T phase aims to promote listening skills through a series of guided compliance teaching sequences. Throughout both phases, parents are also encouraged to develop their own emotion regulation skills through application of a parallel adult-focused C-A-R-E-S model.

Families will first attend a CDI-T teaching session followed by 6-8 CDI-T coaching sessions. When the parent achieves 'mastery' of the CDI-T skills (as per guidelines outlined in Girard et al, 2018), the family will then commence the PDI-T phase. The PDI-T phase will comprise a PDI-T teaching session followed by 6-8 PDI-T coaching sessions. When the parent achieves 'mastery' of the PDI-T skills, the family will then graduate from the program. PCIT-T sessions will be conducted twice weekly for 8 weeks. All sessions will be approximately 45-60 mins in duration and all families in this condition will receive a total of 16 hours of therapy.

The PCIT-T treatment will be delivered by one of 3-4 experienced clinicians (Clinical Psychologists, Nurses) who have been trained and accredited in the PCIT-T intervention. To ensure treatment fidelity, all PCIT-T clinicians will participate in monthly group supervision with a PCIT-T expert throughout the trial. Treatment fidelity will be assessed via (i) clinician-completed post-session integrity checklists after every session, and (ii) review by an external rater of a random selection of 25% of sessions (videotaped). Attendance logs will be kept to enable calculation of total number of sessions attended and total number of therapy hours for each study participant.

ARM 2

Circle of Security Parenting (COS-P) will be delivered according to the protocol outlined by Cooper, Hoffman, & Powell (2009). The COS-P program aims to increase caregiver sensitivity and responsiveness to child cues, empathy for the child by supporting parental reflective functioning, recognition and understanding of child attachment cues, and awareness of the impact of the caregiver’s own attachment history on caregiving patterns. Each of the eight sessions uses pre-filmed clinical DVD footage of secure and problematic parent-child interaction and healthy alternatives to promote group discussion.

The COS-P intervention will include eight 2-hour, weekly group sessions (children not included; childminding will be provided) delivered over an 8-week period. All parents in this condition will receive a total of 16 hours of therapy.

Each COS-P group will be facilitated by 1 or 2 COS-P therapists. The COS-P groups will be delivered by one of 3-4 experienced clinicians (Clinical Psychologists, Psychologists, Psychiatrists, Nurses) who have been trained and accredited in the COS-P intervention. To ensure treatment fidelity, all COS-P clinicians will participate in monthly group supervision with a COS-P expert throughout the trial. Treatment fidelity will be assessed via (i) clinician-completed post-session integrity checklists after every session, and (ii) review by an external rater of a random selection of 25% of sessions (audiotaped). Attendance logs will be kept to enable calculation of total number of sessions attended and total number of therapy hours for each study participant.
Intervention code [1] 301982 0
Behaviour
Intervention code [2] 301983 0
Treatment: Other
Comparator / control treatment
Waitlist
Participants allocated to the waitlist condition will complete an initial baseline assessment measures but will receive no treatment for the next 8-week period. They will then complete the same assessment measures again in the ‘post-waitlist’ assessment, after which point they will exit the study. Families allocated to the Waitlist condition will be offered the opportunity to receive PCIT-T or COS-P (whichever they choose) at the completion of the 8-week waitlist period.
Control group
Active

Outcomes
Primary outcome [1] 306880 0
Child behaviour, as indicated by scores on the Child Behaviour Checklist
Timepoint [1] 306880 0
Baseline, post treatment (primary time point) and 4-months post-treatment
Primary outcome [2] 307400 0
Observed child emotion regulation, as indicated by scores on the Toddler Distress Rating Scale
Timepoint [2] 307400 0
Baseline, post-treatment (primary time point) and 4-months post-treatment
Primary outcome [3] 307401 0
Parent-child attachment relationship quality as indicated by classifications on the Strange Situation Procedure

Timepoint [3] 307401 0
Baseline, post-treatment (primary time point) and 4-months post-treatment
Secondary outcome [1] 351829 0
Parental emotional regulation ability, as indicated by scores on the Difficulties in Emotional Regulation Scale
Timepoint [1] 351829 0
Baseline, post-treatment and 4-months post-treatment.
Secondary outcome [2] 351830 0
Parental mentalising ability, as indicated by codes from a 5-minute maternal speech sample
Timepoint [2] 351830 0
Baseline, post treatment and 4-months post-treatment
Secondary outcome [3] 351863 0
Parenting behaviour, as indicated by scores on the Maternal Behaviour Q-Sort
Timepoint [3] 351863 0
Baseline, post treatment and 4 months post-treatment

Eligibility
Key inclusion criteria
To be included in the study, the child must be aged 14-24 months, and the parent must give a positive response to two brief screening questions [‘Do you have concerns about your child’s behavior?’ and ‘Do have difficulties managing your child’s behavior?’]. Only one parent per family can participate.
Minimum age
14 Months
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Families will be excluded from the study if there is evidence of severe parental depression with suicidality or other serious mental health conditions causing significant impairment in cognition or behaviors (e.g., psychosis) or if they are not proficient in speaking the English language.

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)
Allocation is concealed using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to receive one of the three conditions described below using restricted block randomization, using block sizes of n=6. This means that within each block of n=6, 2 participants will be allocated to the PCIT-T condition, 2 participants will be allocated to the COS-P condition and 2 participants will be allocated to the Waitlist condition. The order will be randomized within each block. Randomisation for each participant will occur at the first baseline assessment (but will not be revealed to the participant or experimenter until the completion of the baseline assessment).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
T-tests and Chi-square tests will be conducted to evaluate baseline differences between groups and identify potential covariates. To test the primary study hypotheses, treatment outcomes will be evaluated using repeated measures ANOVAs. Outcomes at Time 2 (post treatment/post waitlist) will be tested using 3 x 2 repeated measures ANOVAs, with treatment group as the between subjects factor (PCIT-T, COS-P, wait-list) and time as the within subjects factor (Baseline, Time 2). Outcomes at Time 3 (4-month follow-up) will be tested using 2 x 3 repeated measures ANOVAs, with treatment group as the between subjects factor (PCIT-T, COS-P) and time as the within subjects factor (Baseline, Time 2, Time 3). Intention-to-treat analyses (ITT) will be used (participants are analyzed as randomly assigned, regardless of the amount of treatment received). Participants will be included in the ITT sample if they have completed the Baseline Assessment and been randomized. When testing primary hypotheses, adjustments will be made to the alpha level to account for multiple comparisons. Power analyses indicate that for 3 x 2 and 2 x 3 ANOVAs, total samples size of N=27 and N=18, respectively, will be sufficient to detect moderate time*treatment interaction effects (f = 0.33) with power .80 and alpha .05. Estimates were obtained from G*power 3.9.1.2. In order to test secondary hypotheses about a-priori moderators of treatment outcome, we will recruit a larger sample size (N=150, i.e., n=50 participants in each group) to allow detection of small effect sizes (f = .10-.13) with power .80 and alpha .05.

Recruitment
Recruitment status
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
Recruitment hospital [1] 11837 0
Karitane - Carramar
Recruitment postcode(s) [1] 23974 0
2163 - Carramar

Funding & Sponsors
Funding source category [1] 300101 0
University
Name [1] 300101 0
University of New South Wales
Address [1] 300101 0
UNSW Sydney
High St
Kensington, NSW 2052
Australia
Country [1] 300101 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney
High St
Kensington, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 300169 0
None
Name [1] 300169 0
Address [1] 300169 0
Country [1] 300169 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300946 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 300946 0
Research and Ethics Office
Locked Bag 7103, Liverpool BC, NSW, 1871
Ethics committee country [1] 300946 0
Australia
Date submitted for ethics approval [1] 300946 0
28/02/2018
Approval date [1] 300946 0
30/04/2018
Ethics approval number [1] 300946 0
HREC Reference: HREC/18/LPOOL/72 ; Local Project Number: HE18/043

Summary
Brief summary
Background: It is common for toddlers to display disruptive behaviors (e.g., tantrums, aggression, irritability) but when these become severe and persistent, they can be the start of a trajectory towards poor outcomes across the lifespan. Evidence indicates that treatments should be provided for these children as early as possible, i.e., in infancy and the toddler years, to provide the best opportunity for success. A number of attachment theory-based parenting intervention approaches targeting high-risk children and caregivers have been developed, but evidence of their ability to bring improvements in both attachment and behavioral domains in the specific age of toddlerhood (14-24 months) is limited. Parent Child Interaction Therapy (PCIT) is a popular and evidence-based intervention for children with disruptive behaviors. PCIT-T is a promising new adaption of PCIT, developed at the Karitane Toddler Clinic in South Western Sydney, designed to meet the specific developmental needs of toddlers aged 14-24 months. Integrating attachment and behavioral principles, PCIT-T aims to strengthen the quality of the parent-child attachment relationship and seeks to enhance parental capacity to assist emotional and behavioral regulation in the child.

Study aims and method: This study will evaluate the efficacy of the PCIT-T intervention for toddlers aged 14-24 months with disruptive behaviors using a randomized controlled design. One hundred and fifty toddlers with parent reported disruptive behavior will be randomly allocated to receive either PCIT-T, Circle of Security Parent Training (COS-P; a popular attachment-theory based intervention designed to improve parenting and parent-child relationship) or to be in a waitlist control group. Primary outcome variables will include: child behaviour and compliance; child social-emotional functioning (including emotional regulation ability); and parent-child attachment relationship quality. Secondary outcomes will include parental emotional well-being and skill; parenting behaviour, attributions and child abuse potential; and child language. All participating parents will also be invited to take part in a semi-structured interview at the completion of the study to provide qualitative feedback about the program and their perceptions of child outcomes.

Expected outcomes: Delivered in the early intervention period of toddlerhood, PCIT-T has the potential to bring about significant and lasting changes for some of society’s most vulnerable children. Results of this study will thus be of immense public health significance, and will be of interest to clinicians, researchers and policy makers both in Australia and internationally.
Trial website
n/a
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85374 0
Dr Jane Kohlhoff
Address 85374 0
University of New South Wales
C/O: Karitane
P.O. Box 241
Villawood, NSW, 2163
Country 85374 0
Australia
Phone 85374 0
+61 02 97942344
Fax 85374 0
Email 85374 0
Jane.Kohlhoff@unsw.edu.au
Contact person for public queries
Name 85375 0
Dr Jane Kohlhoff
Address 85375 0
University of New South Wales
C/O: Karitane
P.O. Box 241
Villawood, NSW, 2163
Country 85375 0
Australia
Phone 85375 0
+61 02 97942344
Fax 85375 0
Email 85375 0
Jane.Kohlhoff@unsw.edu.au
Contact person for scientific queries
Name 85376 0
Dr Jane Kohlhoff
Address 85376 0
University of New South Wales
C/O: Karitane
P.O. Box 241
Villawood, NSW, 2163
Country 85376 0
Australia
Phone 85376 0
+61 02 97942344
Fax 85376 0
Email 85376 0
Jane.Kohlhoff@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
No Results