Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001267448
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
30/10/2025
Date registered
Help: Date registered
14/11/2025
Date last updated
Help: Date last updated
14/11/2025
Date data sharing statement initially provided
Help: Data sharing statement date
14/11/2025
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
My Toddler and Me Group Program: a pilot trial for caregivers and toddlers aged 11-24 months
Scientific title
An evaluation of the feasibility, acceptability, and effectiveness of the My Toddler and Me Group Program delivered to caregivers and toddlers aged 11-24 months
Additional trial identifiers [1] 315758 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records
This study a pilot trial of the My Toddler and Me Group Program, which is linked to a larger RCT of the My Toddler and Me Group Program (Record: ACTRN12624000584538).

Health condition
Health condition(s) studied:
Child Social-Emotional Functioning 339495 0
Condition category
Condition code
Mental Health 335736 335736 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Name: My Toddler and Me group program
Description: The My Toddler and Me group program, adapted from Parent-Child Interaction Therapy for Toddlers, is an 8-week face-to-face group-based caregiving program designed for caregivers of toddlers approximately 12 to 24 months old. The program consists of 1.5-hour weekly sessions, facilitated by trained clinicians (typically a Psychologist and Child and Family Health Nurse), with caregivers and toddlers attending together. The groups are held in a community-based location (e.g., a local hall). Central to the My Toddler and Me group program is the use of parent-child play, through which parents learn and practice key skills and approaches such as using specific praise, describing play, labelling and managing emotions, and supporting toddlers' listening abilities. The program involves a mix of didactic teaching, role plays, discussions, and live coaching during caregiver-child play sessions. Skills and approaches taught include helping caregivers manage toddlers' emotions, fostering play skills, supporting caregivers in regulating their own emotions, enhancing toddlers' listening abilities, and easing transitions between activities - an area where toddlers often face challenges. It aims to provide an accessible, supportive, and engaging experience, equipping caregivers with the skills and insights needed to build positive caregiver-child relationships and support their toddler’s social-emotional development. Adherence to program is assessed using fidelity checklist completed at the end of each session.
Intervention code [1] 332383 0
Prevention
Intervention code [2] 332462 0
Behaviour
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 343280 0
Feasibility
Timepoint [1] 343280 0
End of each group (8 weeks post-baseline)
Primary outcome [2] 343282 0
Acceptability
Timepoint [2] 343282 0
End of group (8 weeks post-baseline)
Primary outcome [3] 343283 0
Change in caregiver self-efficacy
Timepoint [3] 343283 0
Baseline and post-group (8 weeks post-baseline)
Secondary outcome [1] 454281 0
Change in caregiver helplessness
Timepoint [1] 454281 0
Baseline and post-group (8 weeks post baseline)
Secondary outcome [2] 454282 0
Change in caregiver social connectedness
Timepoint [2] 454282 0
Baseline and post-group (8 weeks post baseline)
Secondary outcome [3] 454283 0
Change in caregiver hostility
Timepoint [3] 454283 0
Baseline and post-group (8 weeks post baseline)
Secondary outcome [4] 454285 0
Change in child behaviour
Timepoint [4] 454285 0
Baseline and post-group (8 weeks post baseline)
Secondary outcome [5] 454286 0
Change in child social-emotional functioning
Timepoint [5] 454286 0
Baseline and post-group (8 weeks post baseline)
Secondary outcome [6] 454287 0
Change in caregiver mentalisation (the ability to understand what their child might be thinking or feeling)
Timepoint [6] 454287 0
Baseline and post-group (8 weeks post baseline)

Eligibility
Key inclusion criteria
Inclusion criteria required that families (a) had a child aged between 11-24 months and (b) were sufficiently proficient in English to participate in an English-speaking group and complete study measures and protocols.
Minimum age
11 Months
Maximum age
24 Months
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Families where severe parental mental illness involving suicidality or significant cognitive or behavioural impairment (e.g., psychosis) is evident.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/04/2023
Date of last participant enrolment
Anticipated
Actual
1/02/2024
Date of last data collection
Anticipated
Actual
29/04/2024
Sample size
Target
20
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 320367 0
Charities/Societies/Foundations
Name [1] 320367 0
Karitane
Country [1] 320367 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Karitane
Address
Country
Australia
Secondary sponsor category [1] 322956 0
None
Name [1] 322956 0
Address [1] 322956 0
Country [1] 322956 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318914 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 318914 0
Ethics committee country [1] 318914 0
Australia
Date submitted for ethics approval [1] 318914 0
31/03/2023
Approval date [1] 318914 0
21/04/2023
Ethics approval number [1] 318914 0
2022/ETH02038

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

Contacts
Principal investigator
Name 145650 0
A/Prof Jane Kohlhoff
Address 145650 0
Karitane, 138-150 The Horsley Dr, Carramar NSW 2163
Country 145650 0
Australia
Phone 145650 0
+61 422 298 785
Fax 145650 0
Email 145650 0
[email protected]
Contact person for public queries
Name 145651 0
Jane Kohlhoff
Address 145651 0
Karitane, 138-150 The Horsley Dr, Carramar NSW 2163
Country 145651 0
Australia
Phone 145651 0
+61 422 298 785
Fax 145651 0
Email 145651 0
[email protected]
Contact person for scientific queries
Name 145652 0
Jane Kohlhoff
Address 145652 0
Karitane, 138-150 The Horsley Dr, Carramar NSW 2163
Country 145652 0
Australia
Phone 145652 0
+61 422 298 785
Fax 145652 0
Email 145652 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.