Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001377820
Ethics application status
Approved
Date submitted
31/07/2021
Date registered
11/10/2021
Date last updated
11/10/2021
Date data sharing statement initially provided
11/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Holding Hands Program: A behaviourally based relationally rich program for parents of toddlers.
Scientific title
The Effect of The Holding Hands Program: Preventative Intervention on the development of Social, Emotional and Behavioural difficulties in Children
Secondary ID [1] 304922 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parent-child relationship difficulties as identified by parent of referring agency 323066 0
Child Social difficulties 323067 0
Child Emotional Difficulties 323560 0
Child Behavioural Difficulties 323561 0
Condition category
Condition code
Mental Health 320645 320645 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventional
Participants in HH are parents who refer or are referred into the UTS: Family Child Behaviour Clinic reporting clinically significant levels of social, emotional, behavioural and/or parenting difficulties in their child(ren) aged 12-60 months. Parents who meet inclusion criteria are invited to participate in 6-8 x 90 minute treatment sessions that address parenting difficulties in the context of early child behaviour problems. Each session comprises a 50-60 minute PARENT-TIME session focused on the delivery of behaviourally based parenting skills followed by a 40 minute KID-TIME session where therapist guided review of progress is undertaken. The number of treatment sessions provided is determined by the supervising psychologist and is based on treatment gains

Behaviorally based programs, also known as Behavioural Family Intervention and Parent Management Training, commonly identify parents as the potential mechanisms of change in child behaviour. The interventions achieve change through the engagement of parents in one of two distinct modes. They either involve

1. the delivery of parenting information to parent(s) in session in the absence of their children, assessment of which is undertaken session by session via parental self-report
2. the direct coaching of parents as they interact with their children, the assessment of which is undertaken session by session via self-report in conjunction with observational coding during session

The current study will combine sessional engagement of parents on their own which, in the current research is termed PARENT-TIME and direct coaching of parents and their children which, in the current research is termed KID-TIME. Drawing on clinic referred children aged between one and three years, and undertaken at UTS: Family Child Behaviour, the current study seeks to assess the potential to increase treatment response by combining these two distinct modes of treatment delivery in a clinic referred population.

The sessions are presented to individual families, one per week, and are run by provisionally registered psychologists under the supervision of an Board approved and Endorsed Clinical Psychologist. Treatment gains are assessed session by session. The sessions have been informed by reviews of applicable scientific literature and informed by the CI's 15 years research and clinical work in the area. Sessional material is presented in a discussive manner that emphasises families as expertise in their own situations and utilises presentation and case scenario material.
Intervention code [1] 321317 0
Treatment: Other
Intervention code [2] 321318 0
Prevention
Intervention code [3] 321319 0
Behaviour
Comparator / control treatment
No comparison group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328458 0
Child behaviour assessed with the Child Behaviour Checklist (CBCL) (Achenbach and Restoria, 2001). CBCL completed by parent(s)
Timepoint [1] 328458 0
Pre-treatment undertaken within two weeks prior to the first treatment session,
Post-treatment undertaken at the completion of treatment (primary time point)
Follow-up undertaken at three months post treatment completion
Primary outcome [2] 328459 0
Change in parenting stress assessed with the Parenting Stress Inventory - Short Form (PSI-SF Ablin 1995). The PSI-SF is completed by parent(s).
Timepoint [2] 328459 0
Pre-treatment undertaken within two weeks prior to the first treatment session,
Post-treatment undertaken at the completion of treatment (primary time point)
Follow-up undertaken at three months post treatment completion
Primary outcome [3] 328460 0
Change in parental emotion regulation is assessed using the Parent Emotion Regulation Scale (Pereira et al. 2017). The PERS is completed bu parent(s).
Timepoint [3] 328460 0
Pre-treatment undertaken within two weeks prior to the first treatment session,
Post-treatment undertaken at the completion of treatment (primary time point)
Follow-up undertaken at three months post treatment completion
Secondary outcome [1] 399085 0
Parent depression, anxiety and stress will be assessed as a composite secondary outcome using the 21 Item Depression Anxiety Stress Scales (DASS-21, Lovibond & Lovibond, 1995)
Timepoint [1] 399085 0
Pre-treatment undertaken within two weeks prior to the first treatment session,
Post-treatment undertaken at the completion of treatment
Follow-up undertaken at three months post treatment completion (secondary time point)
Secondary outcome [2] 401753 0
Parenting Self Efficacy will be assessed as a composite secondary outcome using the Me as a Parent (MaaP; Hamilton et al., 2015). The MaaP is completed by parent(s).
Timepoint [2] 401753 0
Pre-treatment undertaken within two weeks prior to the first treatment session,
Post-treatment undertaken at the completion of treatment
Follow-up undertaken at three months post treatment completion (secondary time point)

Eligibility
Key inclusion criteria
Enrollment on this study will be require parents of families where the target child is aged between 12 and 60 months to be referred into the research as a result of difficulties parenting and parental report places the child(ren) in the in the clinical or sub clinical range on either the Oppositional Defiant or anxiety sub-scales of the CBCL 1.5 - 5.
Minimum age
12 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prospective participants will be excluded on the basis that significant marital/relationship difficulties, significant mental health difficulties, unmanaged substance use, and/or child protection concerns are identified. In these cases, appropriate referrals will be sought for the clients should they wish to pursue this as an option.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Multivariate analyses
mediation and moderation analyses
modelling

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
2/12/2024
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309302 0
University
Name [1] 309302 0
University of Technology Sydney
Country [1] 309302 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Building 20
100 Broadway
Ultimo, NSW 2007
Country
Australia
Secondary sponsor category [1] 310275 0
None
Name [1] 310275 0
Address [1] 310275 0
Country [1] 310275 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309132 0
UTS Health and Medical Research Ethics Committee
Ethics committee address [1] 309132 0
Ethics committee country [1] 309132 0
Australia
Date submitted for ethics approval [1] 309132 0
01/11/2019
Approval date [1] 309132 0
18/05/2020
Ethics approval number [1] 309132 0
ETH20-4705

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

Contacts
Principal investigator
Name 113094 0
Dr John McAloon
Address 113094 0
UTS,
Building 20
100 Broadway
Ultimo NSW 2007
Country 113094 0
Australia
Phone 113094 0
+61412172215
Fax 113094 0
Email 113094 0
[email protected]
Contact person for public queries
Name 113095 0
John McAloon
Address 113095 0
UTS,
Building 20
100 Broadway
Ultimo NSW 2007
Country 113095 0
Australia
Phone 113095 0
+61412172215
Fax 113095 0
Email 113095 0
[email protected]
Contact person for scientific queries
Name 113096 0
John McAloon
Address 113096 0
UTS,
Building 20
100 Broadway
Ultimo NSW 2007
Country 113096 0
Australia
Phone 113096 0
+61 412172215
Fax 113096 0
Email 113096 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified, non re-identifiable data
When will data be available (start and end dates)?
Start date: December 2024
No end date
Available to whom?
Data will be made available on a case by case basis at the discretion of the Chief Investigator
Available for what types of analyses?
any
How or where can data be obtained?
From the study author
John McAloon PhD
Graduate School of Health
University of Technology, Sydney
Level 5, Building 20, 100 Broadway, Ultimo NSW 2007 (PO Box 123)
+61 2 9514 7240
[email protected]


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.