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My Toddler and Me' group program: A hybrid effectiveness-implementation trial testing outcomes for caregivers and toddlers aged 12-24 months

Group Parent-Child Interaction Therapy – Toddler: A hybrid effectiveness-implementation trial testing outcomes for caregivers and toddlers aged 12-24 months

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000584538
Enrollment
219
Registered
2024-05-07
Start date
2024-05-13
Completion date
2026-05-08
Last updated
2026-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project aims to evaluate the effectiveness of 'My Toddler and Me', a group-based parenting intervention adapted from Parent-Child Interaction Therapy for Toddlers, in improving outcomes for caregivers and their toddlers (12-24 months old). Additionally, it seeks to assess implementation outcomes to inform future scaling. Furthermore, the study will investigate the role of biological factors, specifically OXTR polymorphisms, in predicting social-emotional and behavioural issues in toddlers and their response to the 'My Toddler and Me' program. The study will recruit 120 parent-child dyads, randomly allocating them to either the 'My Toddler and Me' program or a waitlist control condition. Parents will complete a series of parent-report questionnaires at baseline, post-treatment/waitlist, and a 3-month follow-up.

Interventions

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 ulti

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.

Sponsors

Karitane
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Caregivers aged 18 years and over, and toddlers aged 12-24 months

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

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026