Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001016628
Ethics application status
Approved
Date submitted
31/08/2023
Date registered
19/09/2023
Date last updated
25/08/2024
Date data sharing statement initially provided
19/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot randomised trial of eConnect for Foster Parents
Scientific title
A pilot randomised trial of an attachment- and trauma-informed parent program in foster care (eConnect-FP)
Secondary ID [1] 310518 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child behavioural and socioemotional functioning 331321 0
Complex trauma 331322 0
Trauma-informed caregiving 331323 0
Condition category
Condition code
Mental Health 328077 328077 0 0
Other mental health disorders
Public Health 328078 328078 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot trial aims to evaluate the implementation and preliminary effectiveness of eConnect for Foster Parents (eConnect-FP), which is an adaptation of the Connect and eConnect Online parent program (Bao & Moretti, 2023; Moretti, Pasalich, & O’Donnell, 2018; Moretti, O’Donnell, & Kelly, 2020). eConnect-FP has been tailored to the specific needs of foster caregivers and their children in care. The intervention is trauma-informed and incorporates key principles from attachment theory. These intervention features are critical to promoting the wellbeing and resilience of children in foster care who have histories of trauma and disrupted attachment relationships.

eConnect-FP will be implemented by practitioners trained in the manualised intervention and provided with ongoing consultation and feedback. Two practitioners will co-facilitate each parent group of around 6 foster caregivers. Groups will meet online weekly for 1.5 hours over 9 weeks. Each Connect session introduces an attachment principle that relates to child development, trauma and foster parenting, 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 foster parenting knowledge and skills to promote secure attachment.
Practitioners’ adherence to the intervention protocol will be assessed via direct observations of the facilitators delivering the program using a sample of video recordings.
Intervention code [1] 326909 0
Behaviour
Intervention code [2] 326910 0
Treatment: Other
Comparator / control treatment
Foster caregivers in the delayed intervention control group will receive care as usual (CAU). CAU includes appropriate support and intervention services provided by 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. Foster caregivers in the control group will be invited to participate in eConnect-FP six months after completing the baseline assessment.
Control group
Active

Outcomes
Primary outcome [1] 335944 0
Composite primary outcome - Feasibility and Fidelity of the Research.
Study feasibility: Rates for enrolment, successful randomisation, research retention as measured by data from study database.
Observed fidelity: Adherence to manual content and competence in delivery as measured by observational ratings of practitioners’ fidelity to the program (e.g., Pasalich et al., 2021).
Timepoint [1] 335944 0
Feasibility: Assessed at baseline and post-intervention (10 weeks after baseline). Observed fidelity: Assessed at post-intervention (10 weeks after baseline).
Primary outcome [2] 335945 0
Composite primary outcome - Program acceptability: Carers' attendance, completion, and self-reported satisfaction with the program via questionnaire (including follow-up qualitative interviews with a subset of carers); practitioners’ satisfaction with the training and program as assessed by a 14-item satisfaction survey (questionnaire specifically designed for this study).
Timepoint [2] 335945 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] 335946 0
Composite primary outcome - Change in children's mental health as measured by the Strengths and Difficulties Questionnaire (SDQ) measuring mental health problems and prosocial behaviour; Affect Regulation Checklist; Inventory of Callous-Unemotional Traits (ICU).
Timepoint [3] 335946 0
Assessed at baseline, post-intervention (10 weeks after baseline) and 6-month follow-up.
Secondary outcome [1] 426237 0
Composite secondary outcome - Change in the quality of the caregiver-child relationship as measured by the Child-Parent Attachment Inventory, Revised Conflict Tactics Scale and Five-Minute Speech Sample (interview/observational assessment of caregiving and relationship quality).
Timepoint [1] 426237 0
Assessed at baseline, post-intervention (10 weeks after baseline) and 6-month follow-up.
Secondary outcome [2] 426238 0
Composite secondary outcome - Change in caregivers' parental satisfaction, mindful parenting levels, and caregiving strain, as measured by the Parenting Sense of Competence Scale, the Interpersonal Mindfulness in Parenting Scale, and the Caregiver Strain Questionnaire - Short Form.
Timepoint [2] 426238 0
Assessed at baseline, post-intervention (10 weeks after baseline) and 6-month follow-up.

Secondary outcome [3] 426239 0
Composite secondary outcome - Change in foster caregiving, specifically caregivers’ parental reflective functioning, parenting joy, and commitment, as measured by the Parental Reflective Functioning Questionnaire, the Parent-Child Joy Scale, and the Caregiver Commitment Questionnaire.
Timepoint [3] 426239 0
Assessed at baseline, post-intervention (10 weeks after baseline) and 6-month follow-up.
Secondary outcome [4] 426240 0
Composite secondary outcome - Children's placement stability as measured using carer reports and administrative data from child protection regarding unplanned placement changes (eg, new placement in out-of-home care).
Timepoint [4] 426240 0
Assessed at 6-month follow-up.

Eligibility
Key inclusion criteria
Foster caregivers will be eligible to participate in the study if they are currently caring for at least one child aged 4-12 years and the child has resided in their current foster care placement for at least four weeks.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria will include foster 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. Foster 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 (4-8 years, 9-12 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 preliminary effectiveness outcomes, “Intent to treat” ANCOVA models will be used to examine group differences (eConnect-FP 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 (eConnect-FP vs. control) and unplanned placement changes at 6-month follow-up.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/01/2024
Actual
3/06/2024
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
2/06/2026
Actual
Sample size
Target
35
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 314720 0
Charities/Societies/Foundations
Name [1] 314720 0
Australian Rotary Health
Country [1] 314720 0
Australia
Primary sponsor type
University
Name
Australian National University
Address
Acton ACT 2601
Country
Australia
Secondary sponsor category [1] 316691 0
None
Name [1] 316691 0
Address [1] 316691 0
Country [1] 316691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313730 0
The Australian National University Human Research Ethics Committee
Ethics committee address [1] 313730 0
Ethics committee country [1] 313730 0
Australia
Date submitted for ethics approval [1] 313730 0
20/12/2022
Approval date [1] 313730 0
21/12/2022
Ethics approval number [1] 313730 0
2017/462

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

Contacts
Principal investigator
Name 129170 0
Dr Dave Pasalich
Address 129170 0
School of Medicine and Psychology, ANU College of Health and Medicine Building, 39 Science Rd Canberra ACT 2601
Country 129170 0
Australia
Phone 129170 0
+61 2 6125 2067
Fax 129170 0
+61 2 6125 0499
Email 129170 0
[email protected]
Contact person for public queries
Name 129171 0
Dave Pasalich
Address 129171 0
School of Medicine and Psychology, ANU College of Health and Medicine Building, 39 Science Rd Canberra ACT 2601
Country 129171 0
Australia
Phone 129171 0
+61 2 6125 2067
Fax 129171 0
+61 2 6125 0499
Email 129171 0
[email protected]
Contact person for scientific queries
Name 129172 0
Dave Pasalich
Address 129172 0
School of Medicine and Psychology, ANU College of Health and Medicine Building, 39 Science Rd Canberra ACT 2601
Country 129172 0
Australia
Phone 129172 0
+61 2 6125 2067
Fax 129172 0
+61 2 6125 0499
Email 129172 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.