Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000921583
Ethics application status
Approved
Date submitted
16/07/2024
Date registered
30/07/2024
Date last updated
30/07/2024
Date data sharing statement initially provided
30/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Steps to Confident Parenting, a program to support parents with an intellectual disability
Scientific title
Evaluation of Steps to Confident Parenting, a program to support parents with an intellectual disability, on parenting skills and capacity
Secondary ID [1] 312543 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intellectual Disability 334426 0
Condition category
Condition code
Mental Health 331055 331055 0 0
Learning disabilities
Public Health 331135 331135 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An intensive (8-12 week), personalised, in person, home-based program for parents, administered by family service workers specialising in parents with an intellectual disability. The program focuses on skill development based on the parents’ specific needs and identified goals. Parenting skills could include routinely administering appropriate child discipline, encouraging healthy eating, and building parent confidence. The practitioner uses different techniques, such as role modelling, employing visual aids, and providing specific feedback to tailor the program to meet the needs of the parent and their family. Approximately four hours per week of the intervention will be administered. This time may be allocated throughout the week as needed, but is usually delivered in one hour blocks.

Family service worker documentation will be used to monitor treatment adherence.
Intervention code [1] 329056 0
Behaviour
Comparator / control treatment
Usual care involves service provision by family services workers within a larger family services organisation. This support is tailored to the needs of the family, and can include both in home and out of home support, and telephone calls. This support may be provided up to 10 hours per week in the form of mentorship and service navigation, and is usually delivered in 1 hour blocks.

Adherence will be assessed via family services worker documentation
Control group
Active

Outcomes
Primary outcome [1] 338822 0
Parenting capacity level determined by protective service child removal
Timepoint [1] 338822 0
12 months after study enrolment
Secondary outcome [1] 437602 0
Parenting Skills
Timepoint [1] 437602 0
6 and 12 months following enrolment
Secondary outcome [2] 437798 0
Parenting self regulation
Timepoint [2] 437798 0
6 and 12 months following enrolment
Secondary outcome [3] 437799 0
Family Functioning
Timepoint [3] 437799 0
6 and 12 months after enrolment
Secondary outcome [4] 438027 0
Parenting skills
Timepoint [4] 438027 0
6 and 12 months after enrolment

Eligibility
Key inclusion criteria
Eligibility Criteria 1 – client has a child/children at risk of requiring care services.
Eligibility Criteria 2 – client has a cognitive or intellectual disability/impairment (diagnosed or undiagnosed).
Eligibility Criteria 3 – client is able to participate in 8/12 week home-based program.
Eligibility Criteria 4 – client lives in the Barwon or Western Metropolitan region of Victoria.
Eligibility Criteria 5 – client is 18 years and over.
Eligibility Criteria 6 – client has at least minimal English language skills.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria 1 – client poses an immediate risk to their child, therefore requiring a Parenting Assessment and Skills Development Service (PASDS) or child protection response.
Exclusion Criteria 2 – client has a transient/unstable housing situation (exceptions can be considered if appropriate housing supports are enacted to facilitate secure housing and support family stability).
Exclusion Criteria 3 – client poses a risk to others.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer generated random function
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other
Other design features
Pragmatic randomisation (participants enter a computer generated lottery and are randomly selected for the intervention - participants not selected after a period of time fall to the control group)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316968 0
Government body
Name [1] 316968 0
Department of Families Fairness and Housing
Country [1] 316968 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Barwon Child and Family Services Alliance
Address
Country
Australia
Secondary sponsor category [1] 319214 0
University
Name [1] 319214 0
Deakin University
Address [1] 319214 0
Country [1] 319214 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315720 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 315720 0
Ethics committee country [1] 315720 0
Australia
Date submitted for ethics approval [1] 315720 0
01/09/2023
Approval date [1] 315720 0
18/09/2023
Ethics approval number [1] 315720 0

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

Contacts
Principal investigator
Name 135602 0
Prof John Toumbourou
Address 135602 0
Deakin Geelong Waurn Ponds Campus, 75 Pigdons Road, Waurn Ponds, Victoria 3216
Country 135602 0
Australia
Phone 135602 0
+61 3 522 78278
Fax 135602 0
Email 135602 0
[email protected]
Contact person for public queries
Name 135603 0
Dr Jesse Shapiro
Address 135603 0
Deakin Melbourne Burwood Campus, 221 Burwood Hwy, Burwood VIC 3125
Country 135603 0
Australia
Phone 135603 0
+61 3 9244 6070
Fax 135603 0
Email 135603 0
[email protected]
Contact person for scientific queries
Name 135604 0
Dr Jesse Shapiro
Address 135604 0
Deakin Melbourne Burwood Campus, 221 Burwood Hwy, Burwood VIC 3125
Country 135604 0
Australia
Phone 135604 0
+61 3 9244 6070
Fax 135604 0
Email 135604 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
High risk of participant identification


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.