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Trial registered on ANZCTR


Registration number
ACTRN12624000584538
Ethics application status
Approved
Date submitted
3/04/2024
Date registered
7/05/2024
Date last updated
7/05/2024
Date data sharing statement initially provided
7/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
'My Toddler and Me' group program: A hybrid effectiveness-implementation trial testing outcomes for caregivers and toddlers aged 12-24 months
Scientific title
Group Parent-Child Interaction Therapy – Toddler: A hybrid effectiveness-implementation trial testing outcomes for caregivers and toddlers aged 12-24 months
Secondary ID [1] 311851 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parenting capacity 333381 0
Child social-emotional functioning 333437 0
Child behavioural functioning 333525 0
Condition category
Condition code
Mental Health 330074 330074 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parent-Child Interaction Therapy for Toddlers (PCIT-T) is an evidence-based parenting program developed for young toddlers aged 12-24 months with early onset behavioural and mental health concerns (Girard et al., 2018; Kohlhoff & Morgan, 2018). The program involves live parent-coaching, either in a clinic setting or in the client's own home via video-conferencing. The aim of PCIT-T is to enhance parents’ use of positive parenting skills and ability to support toddler emotion regulation. The ultimate goals are to improve parent-child relationship quality, child emotion regulation, and child mental health trajectories.

The current study will test outcomes of a new group-based version of PCIT-T called 'My Toddler and Me'. The My Toddler and Me program will be delivered at several of Karitane's Integrated Care Hubs as eight, 1.5-hour weekly sessions. Each group will be delivered over an 8-week period and attended by approximately 6-8 parent-toddler dyads. The group sessions will involve a mix of didactic teaching, group discussions, role plays of new skills/concepts, and live coaching during parent-toddler play sessions.

Each group will be co-facilitated by two clinicians (e.g., Psychologists, Child and Family Health Nurses). The facilitators will all be either a developer of the PCIT-T and 'My Toddler and Me' group program, or will have completed all of the following training components in the 6 months prior to facilitating their first group: 1) a 5-day Parent-Child Interaction Therapy-Toddler (PCIT-T) training workshop (delivered by a PCIT-T developer), followed by at least 6-months of fortnightly group supervision around delivery of individual PCIT-T, and 2) a 3-hour 'My Toddler and Me' group facilitator workshop.

Participant attendance across the 8-sessions will be monitored. Facilitators will deliver the group program in accordance with a standardised facilitator manual (Kohlhoff & Morgan, 2024) and they will complete a fidelity check-list after each session to monitor program fidelity.
Intervention code [1] 328311 0
Prevention
Intervention code [2] 328394 0
Behaviour
Comparator / control treatment
Participants in the control condition will be placed on a 2-month waitlist before receiving Group PCIT-T.
Control group
Active

Outcomes
Primary outcome [1] 337832 0
Caregiver self-efficacy
Timepoint [1] 337832 0
Time 1 assessment (i.e., immediately before intervention or waitlist), Time 2 assessment (i.e., immediately post-intervention assessment) and Time 3 assessment (i.e., 3 months post-completion of PCIT-T; only assessed in the active treatment group).
Primary outcome [2] 337993 0
Caregiver helplessness and stress
Timepoint [2] 337993 0
Time 1 assessment (i.e., immediately before intervention or waitlist), Time 2 assessment (i.e., immediately post-intervention assessment), and Time 3 assessment (i.e., 3 months post-completion of PCIT-T; only assessed in the active treatment group).
Primary outcome [3] 337994 0
Caregiving practices
Timepoint [3] 337994 0
Time 1 assessment (i.e., immediately before intervention or waitlist), Time 2 assessment (i.e., immediately post-intervention assessment) and Time 3 assessment (i.e., 3 months post-completion of PCIT-T; only assessed in the active treatment group).
Secondary outcome [1] 433425 0
Parents' perception of intervention (only assessed in the active treatment group)
Timepoint [1] 433425 0
Time 2 assessment (i.e., immediately post-intervention assessment)
Secondary outcome [2] 434053 0
Child behavioural functioning
Timepoint [2] 434053 0
Time 1 assessment (i.e., immediately before intervention or waitlist), Time 2 assessment (i.e., immediately post-intervention assessment) and Time 3 assessment (i.e., 3 months post-completion of PCIT-T; only assessed in the active treatment group).
Secondary outcome [3] 434054 0
Child social-emotional functioning
Timepoint [3] 434054 0
Time 1 assessment (i.e., immediately before intervention or waitlist), Time 2 assessment (i.e., immediately post-intervention assessment) and Time 3 assessment (i.e., 3 months post-completion of PCIT-T; only assessed in the active treatment group).
Secondary outcome [4] 434059 0
Parents' knowledge gained following Group PCIT-T (only assessed in the active treatment group)
Timepoint [4] 434059 0
Time 2 assessment (i.e., immediately post-intervention assessment)
Secondary outcome [5] 434061 0
Parental perceptions of the child
Timepoint [5] 434061 0
Time 1 assessment (i.e., immediately before intervention or waitlist), Time 2 assessment (i.e., immediately post-intervention assessment) and Time 3 assessment (i.e., 3 months post-completion of PCIT-T; only assessed in the active treatment group).
Secondary outcome [6] 434062 0
Parent mentalisation about child
Timepoint [6] 434062 0
Time 1 assessment (i.e., immediately before intervention or waitlist), Time 2 assessment (i.e., immediately post-intervention assessment) and Time 3 assessment (i.e., 3 months post-completion of PCIT-T; only assessed in the active treatment group).
Secondary outcome [7] 434063 0
Caregivers perceptions of support and connectedness
Timepoint [7] 434063 0
Time 1 assessment (i.e., immediately before intervention or waitlist), Time 2 assessment (i.e., immediately post-intervention assessment) and Time 3 assessment (i.e., 3 months post-completion of PCIT-T; only assessed in the active treatment group).

Eligibility
Key inclusion criteria
Caregivers aged 18 years and over, and toddlers aged 12-24 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) Evidence of severe parental mental illness with suicidality or other serious impairment in cognition or behaviours (e.g., psychosis)
(2) Parents not sufficiently proficient in speaking English to participate in an English-speaking group or to complete study measures and protocols

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A linear mixed models repeated measures design will be used to analyse continuous outcome variables (i.e., parent and child outcome measures) over three-time points (T1, T2, T3). To assess group differences in continuous variables, we will apply family-wise adjustments to raw p-values to account for multiple comparisons using Holm's (1979) stepdown Bonferroni procedure. Between and within group differences will be examined using fixed effects models, utilising planned comparisons to examine differences among the three two groups at T1 and T2, and to examine changes across time for participants in each group. Intention-to-treat analyses (ITT; Gupta, 2011) will be conducted, with participants included in the analysis according to their randomly assigned treatment condition. Group mean values will be estimated based on all observed data within the ITT sample. To gauge the clinical significance of differences in continuous study variables from T1 to T2, and from T1 to T3, we will employ Cohen's d, and evaluate effect sizes according to Cohen's (1988) guidelines. Additionally, we will calculate Reliable Change Index scores to determine whether individual-level changes on continuous study measures exceed the margin of measurement error (Jacobson & Truax, 1991). Finally, hierarchical linear modelling will be used to evaluate 1) the direct and interactive effects of a cumulative OXTR genetic risk factor and adversity on child social-emotional and behavioural functioning; and 2) the moderating effect of the cumulative OXTR genetic risk factor and adversity on Group PCIT-T outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/05/2024
Actual
Date of last participant enrolment
Anticipated
13/10/2025
Actual
Date of last data collection
Anticipated
19/12/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316193 0
Charities/Societies/Foundations
Name [1] 316193 0
Karitane
Country [1] 316193 0
Australia
Funding source category [2] 316198 0
University
Name [2] 316198 0
UNSW Medicine & Health
Country [2] 316198 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Karitane
Address
Country
Australia
Secondary sponsor category [1] 318379 0
University
Name [1] 318379 0
UNSW
Address [1] 318379 0
Country [1] 318379 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315012 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315012 0
Ethics committee country [1] 315012 0
Australia
Date submitted for ethics approval [1] 315012 0
26/10/2023
Approval date [1] 315012 0
01/02/2024
Ethics approval number [1] 315012 0
2023/ETH02448

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133426 0
A/Prof Jane Kohlhoff
Address 133426 0
Karitane P.O. Box 241 Villawood NSW 2163
Country 133426 0
Australia
Phone 133426 0
+61 422298785
Fax 133426 0
Email 133426 0
jane.Kohlhoff@unsw.edu.au
Contact person for public queries
Name 133427 0
Jane Kohlhoff
Address 133427 0
Karitane P.O. Box 241 Villawood NSW 2163
Country 133427 0
Australia
Phone 133427 0
+61 422298785
Fax 133427 0
Email 133427 0
jane.Kohlhoff@unsw.edu.au
Contact person for scientific queries
Name 133428 0
Jane Kohlhoff
Address 133428 0
Karitane P.O. Box 241 Villawood NSW 2163
Country 133428 0
Australia
Phone 133428 0
+61 422298785
Fax 133428 0
Email 133428 0
jane.Kohlhoff@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


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.