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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.
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Scientific title
Co-development of a parenting support program for patients seeking treatment for substance use: A feasibility trial
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Secondary ID [1]
311300
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nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Parenting
332544
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Substance Use
332545
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Condition category
Condition code
Mental Health
329233
329233
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0
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Studies of normal psychology, cognitive function and behaviour
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Public Health
329232
329232
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0
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Health service research
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Mental Health
329231
329231
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0
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Addiction
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
327745
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Treatment: Other
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Intervention code [2]
327746
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Behaviour
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Suitability of a brief group-based parenting support program developed by experts and consumers
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Assessment method [1]
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Qualitative component: Ethnography is a qualitative research methodology and outlines its usefulness in understanding the experiences of patients and service users during their treatment journey. Participants’ responses will be guided by a semi-structured question proforma facilitated by the psychologist delivering the pilot program. All discussions and suggestions will be documented but anonymised for thematic analysis. This method aims to allow the researcher to understand what it is like to be part of the group of patients being studied. In doing so, the researcher is able to gain a greater understanding of their experiences, needs, behaviours, norms, beliefs and values (Strudwick, 2021; Black et al., 2021).
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Timepoint [1]
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Qualitative: Once, right after completing the pilot intervention.
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Primary outcome [2]
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Change in parents' distress tolerance
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Assessment method [2]
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Distress tolerance scale
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Timepoint [2]
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Baseline (pre-intervention), and 1 day, 2 weeks, 6 weeks, and 12 weeks post-intervention.
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Primary outcome [3]
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Parents' substance usage
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Assessment method [3]
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The World Health Organisation's The Alcohol, Smoking and Substance Involvement Screening Test (WHO ASSIST) measure used pre and post-intervention.
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Timepoint [3]
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Baseline (pre-intervention), and 1 day, 2 weeks, 6 weeks, and 12 weeks post-intervention.
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Secondary outcome [1]
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Frequency in the use of harsh parenting strategies
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Assessment method [1]
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Scorers to parent reports to the Child Abuse Screening Tool for use in trials (ICAST-Trial)
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Timepoint [1]
430531
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Baseline (pre-intervention), and 1 day, 2 weeks, 6 weeks, and 12 weeks post-intervention.
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Secondary outcome [2]
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Parental self-efficacy
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Assessment method [2]
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Child Adjustment and Parent Efficacy Scale
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Timepoint [2]
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Baseline (pre-intervention), and 1 day, 2 weeks, 6 weeks, and 12 weeks post-intervention.
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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)
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
20/02/2025
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Actual
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Date of last participant enrolment
Anticipated
1/05/2025
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Actual
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Date of last data collection
Anticipated
2/06/2025
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Actual
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Sample size
Target
12
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
315553
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Government body
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Name [1]
315553
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Department of Health
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Address [1]
315553
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National Centre for Youth Substance Use Research (NCYSUR) at UQ
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Country [1]
315553
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Australia
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Primary sponsor type
University
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Name
The University of Queensland
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Address
Sir Fred Schonell Dr, St Lucia QLD 4067, Austrália
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Country
Australia
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Secondary sponsor category [1]
317641
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Hospital
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Name [1]
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Alcohol and Drug Assessment Unit (ADAU) at the Princess Alexandra Hospital
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Address [1]
317641
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199 Ipswich Rd, Woolloongabba QLD 4102, Austrália
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Country [1]
317641
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314452
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The University of Queensland Human Research Ethics Committee
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Ethics committee address [1]
314452
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Ethics committee at UQ has no address. All contacts available are emails. See this link for clarification https://www.uq.edu.au/research/contact
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Ethics committee country [1]
314452
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Australia
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Date submitted for ethics approval [1]
314452
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23/02/2024
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Approval date [1]
314452
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01/11/2024
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Ethics approval number [1]
314452
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Summary
Brief summary
Approximately 10% of children under the age of 18 reside with at least one parent who has a substance use disorder. For parents seeking treatment for substance use disorder, this increases to more than 25%. There can be a social stigma associated with using both legal and illegal substances while caring for a child. This does not necessarily mean parents/caregivers who use substances are malicious or unable to care for their child. However, it is often common sense that, for those bearing the task of raising a child, managing their own Alcohol and/or Other Drug (AOD) use and seeking treatment can make parenting/caregiving even more challenging. This project aims to trial and co-develop a group-based pilot parenting program developed for adults seeking treatment for their substance use from AOD services who are also parents/caregivers of one or more children aged 5 to 11. The aim of the plot intervention is to increase the use of effective parenting skills in this population to support parent-child positive interaction and aid in children's positive and healthy developmental outcomes. In this respect, the Alcohol and Drug Assessment Unit (ADAU) at the Princess Alexandra Hospital believes there is a moral imperative to include parents seeking treatment for substance use in the development of parenting programs that are relevant to this population. This is because these parents with substance use disorders often lack a clear voice or perceived legitimacy of their values and concerns in relation to caring for their families. Thus, the outcome here will be a brief group-based parenting support program developed by experts in consultation with parents who seek treatment for their AOD use. This program could, therefore, be offered as front-line treatment for adults in integrated AOD treatment services.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Jason Connor
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Address
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National Centre for Youth Substance Use research (NCYSUR), Sir Fred Schonell Dr, St Lucia QLD 4067, Austrália
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Country
131634
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Australia
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Phone
131634
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+61 0410692866
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Fax
131634
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Email
131634
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[email protected]
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Contact person for public queries
Name
131635
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Jason Connor
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Address
131635
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National Centre for Youth Substance Use research (NCYSUR), Sir Fred Schonell Dr, St Lucia QLD 4067, Austrália
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Country
131635
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Australia
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Phone
131635
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+61 7 3365 6230
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Fax
131635
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Email
131635
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[email protected]
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Contact person for scientific queries
Name
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Jason Connor
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Address
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National Centre for Youth Substance Use research (NCYSUR), Sir Fred Schonell Dr, St Lucia QLD 4067, Austrália
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Country
131636
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Australia
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Phone
131636
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+61 7 3365 6230
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Fax
131636
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Email
131636
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[email protected]
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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?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
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.
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