Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000818538
Ethics application status
Approved
Date submitted
29/05/2024
Date registered
3/07/2024
Date last updated
3/07/2024
Date data sharing statement initially provided
3/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation and effectiveness of the Connect for Relative/Kinship Carers program
Scientific title
A randomised controlled trial to evaluate the effectiveness of an attachment- and trauma-informed parent program in relative/kinship care
Secondary ID [1] 312245 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study protocol is based on the preliminary findings from a pilot randomised controlled trial of Connect for Relative/Kinship Carers (please see ACTRN12617000946314)

Health condition
Health condition(s) or problem(s) studied:
Child mental health problems 333949 0
Complex trauma 333950 0
Trauma-informed caregiving 333951 0
Condition category
Condition code
Mental Health 330623 330623 0 0
Other mental health disorders
Public Health 330624 330624 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised controlled trial aims to evaluate the implementation and effectiveness of Connect for Relative/Kinship Carers (Connect-Rel/Kin Carers; Moretti, Ostling, & Pasalich, 2017; Pasalich et al., 2021), which is an adaptation of the Connect parent program (Moretti, Pasalich, & O’Donnell, 2018; Moretti, 2020).

Connect-Rel/Kin Carers has been tailored to the specific needs of relative/kinship caregivers and the children in their care. The program is trauma-informed and incorporates key principles from attachment theory which are applied to the context of relative/kinship care. These intervention features are significant for promoting the wellbeing and resilience of children in relative/kinship care who have histories of trauma and disrupted attachment relationships.

Connect-Rel/Kin Carers will be implemented by caseworkers and practitioners who will be trained in the manualised intervention and then provided with weekly supervision while delivering their first parent group. Caseworkers/practitioners will be trained in the program by members of the research team. Training will take place roughly 4 weeks before the first study cohort is recruited and will involve attendance at 6 half-day training sessions.

Two caseworkers/practitioners will co-facilitate each parent group of around 10 relative/kinship caregivers. Groups will meet weekly for 1.5 hours over 9 weeks. Each Connect-Rel/Kin Carer session introduces an attachment principle that relates to child development, trauma and sensitive caregiving, and captures a key aspect of the caregiver-child relationship and common parenting challenges (e.g., empathy, conflict, growth and change). Experiential activities, including role-plays and reflection exercises, are used to illustrate each principle and build caregiver sensitivity and skills to promote secure attachment and family connectedness.

Intervention fidelity will be assessed using an observational scale developed for the program (see Pasalich et al., 2021) and other indicators of program attendance (e.g., session attendance, program dropouts) will be measured using reports provided by program facilitators.

References:

Moretti, M. M. (2020). Connect: An Attachment Based and Trauma Informed Program for Parents and Caregivers, Third Edition,TM ©. Department of Psychology, Simon Fraser University.

Moretti, M. M., Ostling, O., & Pasalich, D. S. (2017). Connect for Kinship Parents. Department of Psychology, Simon Fraser University

Moretti, M. M., Pasalich, D. S., & O’Donnell, K. A. (2018). An attachment-based program for parents of teens. In H. Steele & M. Steele (Eds.), Handbook of attachment-based interventions. New York, NY: Guilford Press.

Pasalich, D. S., Moretti, M. M., Hassall, A., & Curcio, A. (2021). Pilot randomized controlled trial of an attachment-and trauma-focused intervention for kinship caregivers. Child Abuse & Neglect, 120, 105178.
Intervention code [1] 328693 0
Behaviour
Intervention code [2] 328694 0
Treatment: Other
Comparator / control treatment
Relative/kinship caregivers in the delayed intervention control group will receive care as usual (CAU). CAU includes appropriate support and intervention services provided by child protection or out-of-home care agencies and/or by mental health and other health specialists (based on referrals made by agency staff). Data will be collected regarding the type and frequency of CAU services received by families in both the experimental and control conditions. Relative/kinship caregivers in the control group will be invited to participate in Connect-Rel/Kin Carers six months after completing the baseline assessment.
Control group
Active

Outcomes
Primary outcome [1] 338365 0
Intervention Fidelity
Timepoint [1] 338365 0
Assessed at post-intervention (10 weeks after baseline).
Primary outcome [2] 338366 0
Program Acceptability (composite outcome)
Timepoint [2] 338366 0
Carers’ outcomes assessed post-intervention (10 weeks after baseline); practitioners’ outcomes assessed post- training (immediately after the 3-day practitioner training).
Primary outcome [3] 338367 0
Change in children's mental health (composite outcome)
Timepoint [3] 338367 0
Assessed at baseline, post-intervention (10 weeks after baseline) and 6-month follow-up.
Secondary outcome [1] 435650 0
Change in the quality of the caregiver-child relationship (composite primary outcome)
Timepoint [1] 435650 0
Assessed at baseline, post-intervention (10 weeks after baseline) and 6-month follow-up.
Secondary outcome [2] 435651 0
Change in caregivers’ relational regulatory capacity (composite outcome)
Timepoint [2] 435651 0
Assessed at baseline, post-intervention (10 weeks after baseline) and 6-month follow-up.
Secondary outcome [3] 435652 0
Change in the quality of caregiving, specifically caregivers’ parental reflective functioning, parenting joy, and commitment (composite outcome)
Timepoint [3] 435652 0
Assessed at baseline, post-intervention (10 weeks after baseline) and 6-month follow-up.
Secondary outcome [4] 435653 0
Placement Stability
Timepoint [4] 435653 0
Assessed at 6-month follow-up.

Eligibility
Key inclusion criteria
Relative/kinship caregivers will be eligible to participate in the study if they are currently caring for at least one child aged 4-17 years and the child has resided in their current kinship care placement for at least four weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria will include relative/kinship caregivers of children with psychosis, acute suicidality, and/or severe developmental or intellectual disability.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participant recruitment and allocation will occur in cohorts at several different times across the duration of the study. Relative/kinship caregivers will be identified and then individually screened for eligibility. After obtaining participant consent, caregivers will complete the baseline assessment and will then be randomly allocated to either the intervention or control condition. To ensure concealment of the allocation sequence, a researcher who is not directly involved in the study will (only) be given the study IDs of the enrolled participants and will use a computer-generated randomisation list to randomly assign participants to a condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To ensure that the conditions are balanced with respect to child demographics, randomisation will be stratified by child age (4-10 years, 11-17 years) and gender. Randomisation will be based on a computer-generated randomisation list.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Implementation outcomes will be chiefly examined using descriptive statistics. To evaluate effectiveness outcomes, “Intent to treat” ANCOVA models will be used to examine group differences (Connect-Rel/Kin Carer vs. control) on child and caregiver outcomes at post-intervention and follow-up time points, controlling for scores at baseline. Fisher's exact test will examine the association between group (Connect-Rel/Kin Carer vs. control) and unplanned placement changes at 6-month follow-up.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/07/2024
Actual
Date of last participant enrolment
Anticipated
22/07/2026
Actual
Date of last data collection
Anticipated
1/05/2027
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 316624 0
Government body
Name [1] 316624 0
Australian Research Council
Country [1] 316624 0
Australia
Primary sponsor type
Individual
Name
A/Prof Dave Pasalich
Address
Country
Australia
Secondary sponsor category [1] 318808 0
Government body
Name [1] 318808 0
ACT Community Services Directorate
Address [1] 318808 0
Country [1] 318808 0
Australia
Secondary sponsor category [2] 318809 0
Government body
Name [2] 318809 0
NSW Department of Communities and Justice
Address [2] 318809 0
Country [2] 318809 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315407 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 315407 0
Ethics committee country [1] 315407 0
Australia
Date submitted for ethics approval [1] 315407 0
31/03/2023
Approval date [1] 315407 0
03/04/2023
Ethics approval number [1] 315407 0
2017/462

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

Contacts
Principal investigator
Name 134610 0
A/Prof Dave Pasalich
Address 134610 0
School of Medicine and Psychology, ANU College of Health and Medicine, Building 39 Science Rd, Canberra ACT 2601
Country 134610 0
Australia
Phone 134610 0
+61 02 6125 2067
Fax 134610 0
Email 134610 0
[email protected]
Contact person for public queries
Name 134611 0
Dave Pasalich
Address 134611 0
School of Medicine and Psychology, ANU College of Health and Medicine, Building 39 Science Rd, Canberra ACT 2601
Country 134611 0
Australia
Phone 134611 0
+61 02 6125 2067
Fax 134611 0
Email 134611 0
[email protected]
Contact person for scientific queries
Name 134612 0
Dave Pasalich
Address 134612 0
School of Medicine and Psychology, ANU College of Health and Medicine, Building 39 Science Rd, Canberra ACT 2601
Country 134612 0
Australia
Phone 134612 0
+61 02 6125 2067
Fax 134612 0
Email 134612 0
[email protected]

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.