RecruitingACTRN12618001554257

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

Sponsor

University of New South Wales

Enrollment

150 participants

Start Date

May 3, 2018

Study Type

Interventional

Conditions

childhood behavioural problems

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.

Eligibility

Sex: Both males and femalesMin Age: 14 Monthss

Plain Language Summary

Simplified for easier understanding

It is normal for toddlers to have tantrums and act out, but when these behaviours become severe and persistent, they can be a warning sign of lasting difficulties. Early intervention during toddlerhood — when the brain is highly responsive to learning — offers the best window for meaningful change. Two approaches are compared in this study: Parent-Child Interaction Therapy with Toddlers (PCIT-T), a program developed specifically for this age group that integrates attachment and behaviour strategies, and Circle of Security-Parenting (COS-P), a group-based program focused on strengthening the parent-child relationship. One hundred and fifty toddlers aged 14 to 24 months whose parents report significant behaviour difficulties will be randomly assigned to PCIT-T, COS-P, or a six-month waitlist control group. Researchers will measure changes in child behaviour, emotional regulation, parent-child attachment, and parental wellbeing. Parents in the waitlist group will be offered treatment after six months if their toddler still has difficulties. To be eligible, the child must be aged between 14 and 24 months, and the parent must have concerns about their child's behaviour and find it difficult to manage. Only one parent per family can participate. Families where a parent has severe depression with suicidality or a serious mental health condition that significantly impairs functioning, or who do not speak English proficiently, are not eligible.

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Interventions

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

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.

Locations(1)

Karitane - Carramar

NSW, Australia

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ACTRN12618001554257