Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000196448
Ethics application status
Approved
Date submitted
11/01/2024
Date registered
20/02/2025
Date last updated
20/02/2025
Date data sharing statement initially provided
20/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Co-development of a parenting support program for patients seeking treatment for substance use: Testing a pilot version of the intervention and collecting patients' feedback on the suitability and effectiveness of a new group-based parenting intervention.
Scientific title
Co-development of a parenting support program for patients seeking treatment for substance use: A feasibility trial
Secondary ID [1] 311300 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parenting 332544 0
Substance Use 332545 0
Condition category
Condition code
Mental Health 329233 329233 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 329232 329232 0 0
Health service research
Mental Health 329231 329231 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The present project involves a feasibility trial to test the suitability and effectiveness of a brief group-based parenting support program developed by experts in consultation with patients and Addiction Treatment Service offering front-line treatment in adult clinical services. The test of the suitability of the intervention refers to two aspects. The first aspect is the logistics and relevance of integrating parenting support within an Addiction Treatment Service from both the service and the consumers' standpoints. The second aspect is consulting patients on the relevance and adequacy of the content addressed in the group intervention to the needs for parenting support, as identified by the research participants who will have received the intervention. The test of the effectiveness of the intervention refers to the stability of pre- vs. post-intervention assessment surveys as well as follow-ups (2 weeks, 6 weeks, and 12 weeks).

A summary of the content of the program includes addressing both parenting and substance use-related topics such as self-assessment and reflection on the impact of substance use on parenting, motivational interviewing to aid in treatment engagement and motivation to reduce substance use and use positive parenting skills, parent-child interaction and relationship, child behaviour management skills, family trauma, parental distress tolerance, and associated guilt and shame.

The complete group-based parent intervention pilot program has a total of 5 hours that will be delivered in two group sessions of 2.5 hours each. The two group sessions will be conducted in two consecutive days to maximize the participants' motivation and increase adherence to the program. The delivery modality of the groups includes interactive activities such as discussions, role-plays, videos, and hypothetical vignettes followed by reflections. They also include educational materials such as short questionnaires and hand-out materials that participants can take home.

After the group intervention, the co-development part of the study begins. This consists of a semi-structured qualitative interview with each participant to collect their feedback and suggestions on the intervention. This interview will be conducted in person or online (phone or video call) by a psychologist researcher different from the person who delivered the intervention. A summary of the content of this intervention includes reports of their experience with the intervention delivery modality and the relevance of the topics addressed to their parenting needs in the context of managing their substance use and treatment.

As it is a requirement that the participants are engaged with the substance use treatment within the service in which they will have been recruited, specific strategies to monitor adherence to this feasibility trial are not applicable.
Intervention code [1] 327745 0
Treatment: Other
Intervention code [2] 327746 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337068 0
Suitability of a brief group-based parenting support program developed by experts and consumers
Timepoint [1] 337068 0
Qualitative: Once, right after completing the pilot intervention.
Primary outcome [2] 337071 0
Change in parents' distress tolerance
Timepoint [2] 337071 0
Baseline (pre-intervention), and 1 day, 2 weeks, 6 weeks, and 12 weeks post-intervention.
Primary outcome [3] 337069 0
Parents' substance usage
Timepoint [3] 337069 0
Baseline (pre-intervention), and 1 day, 2 weeks, 6 weeks, and 12 weeks post-intervention.
Secondary outcome [1] 430531 0
Frequency in the use of harsh parenting strategies
Timepoint [1] 430531 0
Baseline (pre-intervention), and 1 day, 2 weeks, 6 weeks, and 12 weeks post-intervention.
Secondary outcome [2] 430532 0
Parental self-efficacy
Timepoint [2] 430532 0
Baseline (pre-intervention), and 1 day, 2 weeks, 6 weeks, and 12 weeks post-intervention.

Eligibility
Key inclusion criteria
- Aged 18 or above.
- Parenting at least one child aged between 5 to 11
- Presented to the AOD service seeking treatment for themselves about an AOD-related problem in the past two weeks and are parents/caregivers who have at least one child under their care.
- The World Health Organisation (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) score either equal to or greater than 10 for alcohol use or equal to or greater than 4 on the ASSIST for illicit drug use (WHO ASSIST Working Group, 2002)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Not fluent in spoken or written English
- Current high suicide risk (current intent and plan)
- Current psychosis
- Currently in acute alcohol or drug withdrawal

Study design
Purpose of the study
Educational / counselling / training
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 design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/02/2025
Actual
Date of last participant enrolment
Anticipated
1/05/2025
Actual
Date of last data collection
Anticipated
2/06/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 315553 0
Government body
Name [1] 315553 0
Department of Health
Country [1] 315553 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Sir Fred Schonell Dr, St Lucia QLD 4067, Austrália
Country
Australia
Secondary sponsor category [1] 317641 0
Hospital
Name [1] 317641 0
Alcohol and Drug Assessment Unit (ADAU) at the Princess Alexandra Hospital
Address [1] 317641 0
199 Ipswich Rd, Woolloongabba QLD 4102, Austrália
Country [1] 317641 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314452 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 314452 0
Ethics committee country [1] 314452 0
Australia
Date submitted for ethics approval [1] 314452 0
23/02/2024
Approval date [1] 314452 0
01/11/2024
Ethics approval number [1] 314452 0

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

Contacts
Principal investigator
Name 131634 0
Prof Jason Connor
Address 131634 0
National Centre for Youth Substance Use research (NCYSUR), Sir Fred Schonell Dr, St Lucia QLD 4067, Austrália
Country 131634 0
Australia
Phone 131634 0
+61 0410692866
Fax 131634 0
Email 131634 0
[email protected]
Contact person for public queries
Name 131635 0
Jason Connor
Address 131635 0
National Centre for Youth Substance Use research (NCYSUR), Sir Fred Schonell Dr, St Lucia QLD 4067, Austrália
Country 131635 0
Australia
Phone 131635 0
+61 7 3365 6230
Fax 131635 0
Email 131635 0
[email protected]
Contact person for scientific queries
Name 131636 0
Jason Connor
Address 131636 0
National Centre for Youth Substance Use research (NCYSUR), Sir Fred Schonell Dr, St Lucia QLD 4067, Austrália
Country 131636 0
Australia
Phone 131636 0
+61 7 3365 6230
Fax 131636 0
Email 131636 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Data is considered to contain highly sensitive information on substance use and child maltreatment that could expose individuals and result in harmful implications for them that may impair the therapeutical effects of their AOD use treatment and the parenting support, per consequence.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  [email protected]
Statistical analysis plan  [email protected]
Informed consent form  [email protected]
Ethical approval  [email protected]
Analytic code  [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.