Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12617000946314
Ethics application status
Approved
Date submitted
26/06/2017
Date registered
3/07/2017
Date last updated
12/08/2019
Date data sharing statement initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Connect Research Project: A trial of a trauma- and attachment-based intervention in kinship and foster care
Scientific title
Evaluation of the feasibility and effectiveness of a trauma- and attachment-based parent intervention in home-based care
Secondary ID [1] 292231 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child behavioural and socioemotional functioning 303780 0
Complex trauma 303781 0
Trauma-informed caregiving 303782 0
Condition category
Condition code
Mental Health 303148 303148 0 0
Other mental health disorders
Public Health 303149 303149 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to evaluate the implementation and preliminary effectiveness of a modified version of the Connect parent program (see Moretti, Pasalich, & O’Donnell [2018], Handbook of Attachment-Based Interventions, for a review) for children in kinship and foster care. The version of the Connect program trialled in this study has been tailored to the specific needs of alternative/kin carers and children in home-based 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 home-based care who have histories of trauma and disrupted attachment relationships.

The Connect parent program will be implemented by practitioners (including psychologists, counsellors and social workers) in child welfare and out-of-home-care services, who will be trained in the manualised intervention and provided with ongoing consultation and feedback. Two practitioners will co-facilitate each parenting group of 8-10 kinship or foster carers. Groups will meet weekly for 1.5 hours over 9 weeks at a local community centre. Each Connect session introduces an attachment principle that relates to child development, trauma and home-based care, 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 parenting knowledge and skills to promote secure attachment.

Practitioners’ adherence to the intervention protocol will be assessed via direct observations of the leaders delivering the program using a sample of video recordings.
Intervention code [1] 298441 0
Behaviour
Intervention code [2] 298442 0
Treatment: Other
Comparator / control treatment
Families in the delayed intervention control group will receive care as usual (CAU). CAU includes support and intervention services provided by the child protection agency 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. Kinship/foster carers in the control group will be offered the Connect program six months after completing the baseline assessment.
Control group
Active

Outcomes
Primary outcome [1] 302523 0
Change in children's dysregulated behaviour and emotions as measured by the Strengths and Difficulties Questionnaire and Affect Regulation Checklist.
Timepoint [1] 302523 0
Assessed at baseline, immediately post-intervention (10 weeks after baseline) and 6-month follow-up.
Primary outcome [2] 302524 0
Change in the quality of the caregiver-child relationship as measured by the Comprehensive Child-Parent Attachment Inventory and Revised Conflict Tactics Scale.
Timepoint [2] 302524 0
Assessed at baseline, immediately post-intervention (10 weeks after baseline) and 6-month follow-up.
Secondary outcome [1] 336284 0
Change in caregivers' parental satisfaction as measured by the Parenting Sense of Competence Scale.
Timepoint [1] 336284 0
Assessed at baseline, immediately post-intervention (10 weeks after baseline) and 6-month follow-up.
Secondary outcome [2] 336285 0
Change in carers' caregiving strain as measured by the Caregiver Strain Questionnaire - Short Form.
Timepoint [2] 336285 0
Assessed at baseline, immediately post-intervention (10 weeks after baseline) and 6-month follow-up.
Secondary outcome [3] 336286 0
Change in caregivers' reflective functioning as measured by the Five-Minute Speech Sample.
Timepoint [3] 336286 0
Assessed at baseline, immediately post-intervention (10 weeks after baseline) and 6-month follow-up.
Secondary outcome [4] 336287 0
Change in caregivers' mindful parenting as measured by the Interpersonal Mindfulness in Parenting Scale.
Timepoint [4] 336287 0
Assessed at baseline, immediately post-intervention (10 weeks after baseline) and 6-month follow-up.
Secondary outcome [5] 336434 0
Change in children's prosocial emotions as measured by the Inventory of Callous-Unemotional Traits.
Timepoint [5] 336434 0
Assessed at baseline, immediately post-intervention (10 weeks after baseline) and 6-month follow-up.
Secondary outcome [6] 336442 0
Change in children's traumatic stress as measured by the Child PTSD Symptom Scale.
Timepoint [6] 336442 0
Assessed at baseline, immediately post-intervention (10 weeks after baseline) and 6-month follow-up.
Secondary outcome [7] 336443 0
Children's placement stability as measured by children's placement records.
Timepoint [7] 336443 0
Assessed at baseline, immediately post-intervention (10 weeks after baseline) and 6-month, 12-month and 24-month follow-up.

Eligibility
Key inclusion criteria
Children will be eligible to participate in the study if they are aged 8-16 years and have resided in their current home-based care placement for at least four weeks.

Caregivers will be eligible to participate if they are currently supporting a child in a kinship or foster care placement.
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Families will be excluded from participating in the study based on child and/or kinship/foster carer characteristics. Exclusion criteria concerning children includes: currently in a crisis/emergency situation, severe mental illness (e.g., schizophrenia, bipolar disorder), significant physical health care needs, severe developmental disability, and/or severe intellectual disability. Families will also be excluded if carers have a severe mental illness or substance use problem, and are unable to speak sufficiently fluent English and/or have limited comprehension of English.

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. Families will be identified and then individually screened for eligibility. After obtaining participant consent or assent (for children aged 11 years or younger), carers and children in each family will complete the baseline assessment. Families 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 the number of pre-teens and teens, and boys and girls, randomisation will be stratified by child age (8-11 years, 12-16 years) and sex. 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
Safety/efficacy
Statistical methods / analysis
“Intent to treat” ANCOVA models will be used to examine group differences (Connect vs. control) on child and caregiver outcomes at post-intervention and follow-up time points. Missing data (attrition estimated at 15%) will be handled using multiple imputation. Structural equation modeling (SEM) will be used to replicate and expand on mediation models found in prior evaluations of the Connect intervention model. SEM will also be used to examine the moderation of child and caregiver variables at baseline on program effects on dependent variables. Missing data in the mediation and moderation models will be handled using full information maximum likelihood.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/12/2017
Actual
15/01/2018
Date of last participant enrolment
Anticipated
9/10/2020
Actual
Date of last data collection
Anticipated
1/11/2021
Actual
Sample size
Target
60
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 296779 0
Government body
Name [1] 296779 0
Australian Research Council
Country [1] 296779 0
Australia
Funding source category [2] 296828 0
University
Name [2] 296828 0
The Australian National University
Country [2] 296828 0
Australia
Funding source category [3] 296829 0
Government body
Name [3] 296829 0
ACT Community Services Directorate
Country [3] 296829 0
Australia
Primary sponsor type
University
Name
The Australian National University
Address
Acton ACT 2601
Country
Australia
Secondary sponsor category [1] 295820 0
Government body
Name [1] 295820 0
ACT Child and Youth Protection Services
Address [1] 295820 0
GPO Box 158
Canberra City ACT 2601
Country [1] 295820 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298004 0
The Australian National University Human Research Ethics Committee
Ethics committee address [1] 298004 0
Ethics committee country [1] 298004 0
Australia
Date submitted for ethics approval [1] 298004 0
20/06/2017
Approval date [1] 298004 0
23/08/2017
Ethics approval number [1] 298004 0

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

Contacts
Principal investigator
Name 75702 0
Dr Dave Pasalich
Address 75702 0
Research School of Psychology
ANU College of Health and Medicine
Building 39 Science Rd
Canberra ACT 2601
Country 75702 0
Australia
Phone 75702 0
+61 2 6125 2067
Fax 75702 0
+61 2 6125 0499
Email 75702 0
[email protected]
Contact person for public queries
Name 75703 0
Dave Pasalich
Address 75703 0
Research School of Psychology
ANU College of Health and Medicine
Building 39 Science Rd
Canberra ACT 2601
Country 75703 0
Australia
Phone 75703 0
+61 2 6125 2067
Fax 75703 0
+61 2 6125 0499
Email 75703 0
[email protected]
Contact person for scientific queries
Name 75704 0
Dave Pasalich
Address 75704 0
Research School of Psychology
ANU College of Health and Medicine
Building 39 Science Rd
Canberra ACT 2601
Country 75704 0
Australia
Phone 75704 0
+61 2 6125 2067
Fax 75704 0
+61 2 6125 0499
Email 75704 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3894Ethical approval  [email protected]



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.