Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000645459
Ethics application status
Approved
Date submitted
12/05/2025
Date registered
18/06/2025
Date last updated
18/06/2025
Date data sharing statement initially provided
18/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Holding Hands Program: A parenting Intervention for parents of young children designed to address parent emotion, child behaviour, and parent-child relationships.
Scientific title
The Holding Hands Program: The effect of relational-behavioural treatment on emotion regulation in parents of young children with early markers of risk for poor mental health outcomes
Secondary ID [1] 314364 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parent-child relational difficulties 337361 0
Parent emotional difficulties 337362 0
Child emotional Difficulties 337363 0
Child behavioural difficulties 337364 0
Condition category
Condition code
Mental Health 333747 333747 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Holding Hands Program is a program of preventative intervention designed to interrupt trajectories toward child social, emotional, and behavioural difficulties as they commence in young children. It addresses parent emotion regulation, child behaviour and parent-child relationships by delivering treatment components targeting parent, parenting and child outcomes.
Holding Hands is delivered online from the UTS: Family Child Behaviour Clinic to parent(s) or carers of individual families It is delivered to families reporting clinically significant levels of child social, emotional, or behavioural difficulties, and/or parenting difficulties in their child(ren) aged 12-60 months. Families are engaged following a screening process that ensures that it is an appropriate program for each family and that referral to another service is not warranted. Preliminary online psychometric assessment utilises the CBCL and the PSI. A Holding Hands Practitioners Manual is used to guide delivery of treatment and it contains sessional handouts relevant to material presented in each treatment module.
Prior to entry into the program, informed consent is gained from parent(s) and carers and they are provided with an account of mandatory reporting and limitations to confidentiality. They then proceed through six treatment modules, the length of which varies depending on the family, their characteristics of presentation and their capacity. Briefly, the modules cover the definition, identification, and contingent engagement of desirable child functioning; the regulation of parental emotion; the application parent and parenting skill in ecologically valid settings using video; the consolidation of regulated parental emotion and contingent engagement of desirable child behaviour; dispassionate responding to undesirable child functioning and it’s implications for child behaviour; and parent’s capacity to perceive the world from their child’s perspective and ways to ensure that treatment gains demonstrated are maintained.
Holding Hands will be delivered online from the UTS Family Child Behaviour Clinic to parent(s) or carers of individual families by Master of Clinical Psychology students in their final year of clinical training. The Six modules of the program are delivered over 6-12 60 minute weekly sessions depending on family characteristics of presentation and capacity, Sessions are comprised of brief assessment live didactic teaching, interactive discussion, discussion about the application of skills and setting and review of homework tasks. The order of the six program modules is established and must be maintained, however, individual sessions remain responsive to individual family characteristics and needs, and as a result may vary in focus or number.
Intervention adherence and fidelity will be discussed and assessed within daily clinical supervision provided by an endorsed Clinical Psychologist and Psychology Board of Australia Board Approved Supervisor. Practitioner self-assessment is sought session by session and this, together with sessional psychometrics, provides an informed basis on which to maintain adherence to the program manual.
Intervention code [1] 331028 0
Prevention
Intervention code [2] 331029 0
Behaviour
Comparator / control treatment
The trial will use a waitlist to gauge participants responses to psychometrically based intake assessment. They will remain on waitlist for four months and complete any treatment that they are undertaking as usual. Participants will then be assessed at the end of their time on waitlist to assess the stability of any parenting stress and child's presenting symptoms that were initially reported. Treatment will then be offered to everyone whose symptoms remain in the clinical or subclinical range and treatment data will involve psychometric assessment at pre, post, and three month follow-up. Waitlist control will have assessment data on entry (pre) into waitlist and exit (post) from it.
Follow-up data will not be provided for waitlist control.
Control group
Active

Outcomes
Primary outcome [1] 341421 0
Child Behaviour
Timepoint [1] 341421 0
Pre-treatment assessment will be undertaken one week prior to the first treatment session, Post-treatment assessment will be undertaken at the completion of treatment (primary time point). Follow-up assessment will be undertaken three months after treatment has been completed
Primary outcome [2] 341422 0
Parenting stress
Timepoint [2] 341422 0
Pre-treatment assessment will be undertaken one week prior to the first treatment session, Post-treatment assessment will be undertaken at the completion of treatment (primary time point). Follow-up assessment will be undertaken three months after treatment has been completed
Primary outcome [3] 341423 0
Change in parental emotion regulation
Timepoint [3] 341423 0
Pre-treatment assessment will be undertaken one week prior to the first treatment session, Post-treatment assessment will be undertaken at the completion of treatment (primary time point). Follow-up assessment will be undertaken three months after treatment has been completed
Secondary outcome [1] 447454 0
Parent depression, anxiety and stress will be assessed as a composite outcome
Timepoint [1] 447454 0
Pre-treatment assessment will be undertaken one week prior to the first treatment session, Post-treatment assessment will be undertaken at the completion of treatment and follow-up assessment will be undertaken at three months post program completion
Secondary outcome [2] 447455 0
Parenting Self Efficacy.
Timepoint [2] 447455 0
Pre-treatment assessment will be undertaken one week prior to the first treatment session, Post-treatment assessment will be undertaken at the completion of treatment and follow-up assessment will be undertaken at three months post program completion

Eligibility
Key inclusion criteria
Enrollment in this trial requires parent(s) of families with the target child is aged between 12 and 60 months to be referred into the Holding Hands Program for treatment because of child social, emotional or behavioural challenges and/or because of difficulties in parenting. Psychometric assessment (parent report) must place children in the clinical or subclinical range on either the Oppositional Defiant or Anxiety sub-scales of the CBCL 1.5 - 5.
Minimum age
12 Months
Maximum age
60 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prospective participants will be excluded if they fall outside inclusion criteria or 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 those 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
Other
Other design features
Waitlist control: prospective participants of the trial will be assessed on contact to ensure they meet inclusion criteria. At this time they will also be informed that they will be placed on a wait list until they are allocated into the program during which time they are encouraged to continue with any treatment and services they currently access. If they prefer, we will provide them with options for alternative treatment at this time. At the conclusion of their time on the waitlist (3 months), they will be reassessed to establish the stability of child and parent characteristics of presentation, They will then be inducted into the program and their progress assessed on treatment completion and at three months follow-up.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Multivariate analyses
Mediation and moderation analyses
statistical modelling

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/03/2025
Date of last participant enrolment
Anticipated
12/12/2027
Actual
Date of last data collection
Anticipated
15/03/2028
Actual
Sample size
Target
120
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318885 0
University
Name [1] 318885 0
University of Technology Sydney
Country [1] 318885 0
Australia
Primary sponsor type
Individual
Name
Dr John McAloon - University of Technology Sydney
Address
Country
Australia
Secondary sponsor category [1] 321352 0
University
Name [1] 321352 0
University of Technology Sydney
Address [1] 321352 0
Country [1] 321352 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317502 0
UTS Health and Medical Research Ethics Committee
Ethics committee address [1] 317502 0
Ethics committee country [1] 317502 0
Australia
Date submitted for ethics approval [1] 317502 0
21/10/2024
Approval date [1] 317502 0
28/11/2024
Ethics approval number [1] 317502 0
ETH24-10132

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

Contacts
Principal investigator
Name 141250 0
Dr John McAloon
Address 141250 0
Family Child Behaviour Clinic, University of Technology Sydney, Level 10 Building 20, 100 Broadway, Ultimo 2007, NSW
Country 141250 0
Australia
Phone 141250 0
+61 2 9514 7240
Fax 141250 0
Email 141250 0
[email protected]
Contact person for public queries
Name 141251 0
John McAloon
Address 141251 0
Family Child Behaviour Clinic, University of Technology Sydney, Level 10 Building 20, 100 Broadway, Ultimo 2007, NSW
Country 141251 0
Australia
Phone 141251 0
+61 2 9514 7240
Fax 141251 0
Email 141251 0
[email protected]
Contact person for scientific queries
Name 141252 0
John McAloon
Address 141252 0
Family Child Behaviour Clinic, University of Technology Sydney, , Level 10 Building 20, 100 Broadway, Ultimo 2007, NSW
Country 141252 0
Australia
Phone 141252 0
+61 2 9514 7240
Fax 141252 0
Email 141252 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Consistent with our HREC approval, all data used for analysis will be deidentified and aggregated. The only reason individual data would be shared is if a child protection report is warranted, or risk is identified to or from any person within the context of the trial.



What supporting documents are/will be available?



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.