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Trial registered on ANZCTR


Registration number
ACTRN12614000450617
Ethics application status
Approved
Date submitted
18/03/2014
Date registered
1/05/2014
Date last updated
1/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Developing an Australian-first recovery model for parents in Victorian mental health and family services.
Scientific title
A randomised control trial of Let’s Talk About Children on the mental health recovery of parents with a mental illness.
Secondary ID [1] 284285 0
none
Universal Trial Number (UTN)
U1111-1154-642
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health
 291428 0
Condition category
Condition code
Mental Health 291791 291791 0 0
Schizophrenia
Mental Health 291792 291792 0 0
Depression
Mental Health 291793 291793 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
“Let's Talk About Children” is an intervention that is applied by adult mental health clinicians to engage with and support parents who have a mental illness in relation to their families and children. Within the 2-3 session intervention the clinician assists the parent to chart the developmental progress of their children, monitor their wellbeing and to talk to their children about the illness and possible impacts on them and the family. The program provides training for clinicians to, talk to parents, who have a mental illness, about their children, discuss with parents the impact of the mental illness on the children and assist parents in supporting their children to better understand and cope with parental mental illness. The intervention is implemented in 3 sessions however with clinician and parent agreement this is reduced to 2 sessions based on their judgement that the 3rd session is not required. Sessions are implemented for 60 minutes once per week. Clinicians are trained in the intervention by completing 4 online modules (1 hour each) along with a follow up 4 hour face to face training session. The face-to-face clinician training is undertaken within 2 weeks of completing the online modules and the intervention is implemented with parents within 1 month. The face-to-face training is facilitated by a trained experienced clinician.
Intervention code [1] 289000 0
Behaviour
Comparator / control treatment
The wait list control group will be offered the intervention after 6 months.
Control group
Active

Outcomes
Primary outcome [1] 291716 0
Recovery as measured by the Australian Quality of Life - 8D scale
Timepoint [1] 291716 0
6 months post intervention
Primary outcome [2] 291717 0
Parenting as measured by the Parenting Stress scale
Timepoint [2] 291717 0
6 months post intervention
Primary outcome [3] 291718 0
Family functioning as measured by the family assessment device
Timepoint [3] 291718 0
6 months post intervention
Secondary outcome [1] 307343 0
nil
Timepoint [1] 307343 0
nil

Eligibility
Key inclusion criteria
Clients of the participating services
Diagnosed mental illness
Parent living at least some time with children
Over 18 years of age
Capable of giving informed consent as identified by their treating practitioners
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-english speaking clients
Non-custodial parents
Parents deemed too unwell by the clinician to participate in the study (where it is deemed by the practitioner for involvement to do harm to the client) or to be able to provide consent.

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)
Parent-clients on the caseload of trained Let’s Talk (LT) practitioners will be advised of a research project into recovery by their treating practitioner. They will also receive a brief introduction to the research containing a consent form to be contacted for further information. If potential parent-clients are interested in receiving more information about the study, the parent-client will complete the contact details form and forward to the researchers (by fax, email or reply paid envelope). The researchers will then contact the parent-client to provide a detailed verbal and written description of the research and to determine their willingness to consent to being involved in the study.

All parent-clients agreeing to participate in the study will be sent a questionnaire pack containing survey measures on recovery, parenting stress and family functioning. A reply paid envelope will be provided with the questionnaire pack for the parent-client to complete and post themselves, or the parent-clients can nominate to be called by the researchers for completion over the phone if they wish. Parent-clients will also complete questionnaire packs (as above) at two later time frames – 6 weeks after completing LT below (or equivalent time frame - an estimated 10 weeks after pre questionnaires) for wait list controls and then a third identical questionnaire package at follow-up (6 to 12 months post LT).

Following the completion of the first questionnaire package all participating parent-clients will then be randomised to either: (1) wait list control group or (2) Let’s Talk (LT) intervention group. The researchers will initially be blind to the allocation of the participant at the collection of informed consent and collection of the baseline data. Following this, an independent admin officer will be contacted to allocate the participant based on the computer generated random sequence allocation that they will maintain. The researcher will advise the practitioner of the outcome of the allocation and from this point on the research assistant who will remain blind to the allocation will collect the post and follow-up questionnaire data. At this stage, parent-clients allocated to the LT group will be advised of the intervention by their treating practitioner and asked if they would like to participate in the intervention. The practitioner will undertake the intervention according to agreement with their parent- client. If there is agreement the parent client will receive the two to three session LT intervention from their practitioner. If the parent- client declines the LT intervention they will continue with treatment as usual with their practitioner. Participants will also be advised that they can decline the intervention but continue to participate in the research study or be involved in the intervention and decline to be involved further in the research.

The intervention involves a discussion between the parent-client and their practitioner about their children, to discuss with parents the potential impact of the mental illness on the children and to assist parents in supporting their children to better understand and cope with parental mental illness. The intervention includes charting the developmental progress of their children, monitoring their well-being and supporting the parent to talk to their children about the illness and possible impacts on them and the family.

Both intervention and wait list groups will continue to complete the questionnaires at post and follow up data collections as indicated above. The control group will continue to receive ‘treatment as usual’ from their clinician and will be informed about (and offered) LT as they complete the final follow up questionnaire. Of those parents who also consented to be interviewed they may be invited to participate in a semi-structured interview approximately 10 weeks after completing the first questionnaire package. Primarily the interview aims to ascertain their experience of the intervention and any impact it may have had on them and their family.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be developed by computer generation of random number sequences via SPSS by the project manager prior to commencing the project, and maintained by the admin officer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed models repeated measures models

Participant numbers were initially determined by a power calculation indicating a minimum n equals 54 participants with Crit F equal to 2.46 (using GPOWER 3.1, assuming 3 sectors and 3 repetitions, a small effect size, an alpha of 5% and power of 95%) to be required. However 72 participants will be engage in the study to account for parent and family dropout.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2014
Actual
4/04/2014
Date of last participant enrolment
Anticipated
30/11/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288912 0
Government body
Name [1] 288912 0
Victorian Department of Health
Country [1] 288912 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton
Victoria 3800
Country
Australia
Secondary sponsor category [1] 287608 0
None
Name [1] 287608 0
none
Address [1] 287608 0
none
Country [1] 287608 0
Other collaborator category [1] 277873 0
University
Name [1] 277873 0
La Trobe University
Address [1] 277873 0
The Bouverie Centre,
8 Gardiner St
Brunswick
Victoria 3056

Country [1] 277873 0
Australia
Other collaborator category [2] 277874 0
Charities/Societies/Foundations
Name [2] 277874 0
Parenting Research Centre
Address [2] 277874 0
5/232 Victoria Parade,
East Melbourne
Victoria 3002
Country [2] 277874 0
Australia
Other collaborator category [3] 277875 0
University
Name [3] 277875 0
University of Melbourne
Address [3] 277875 0
Grattan St,
Parkville
Victoria 3010
Country [3] 277875 0
Australia
Other collaborator category [4] 277876 0
University
Name [4] 277876 0
Deakin University
Address [4] 277876 0
221 Burwood Highway,
Burwood,
Victoria 3125
Country [4] 277876 0
Australia
Other collaborator category [5] 277877 0
Charities/Societies/Foundations
Name [5] 277877 0
SANE
Address [5] 277877 0
PO Box 226
South Melbourne
Victoria 3205
Country [5] 277877 0
Australia
Other collaborator category [6] 277878 0
Charities/Societies/Foundations
Name [6] 277878 0
Family Life – SHINE
Address [6] 277878 0
Suite 2,
450 Nepean Highway,
Chelsea,
Victoria 3196
Country [6] 277878 0
Australia
Other collaborator category [7] 277879 0
Government body
Name [7] 277879 0
Eastern Health Mental Health Service
Address [7] 277879 0
Davey Drive,
Ringwood East
Victoria 3135
Country [7] 277879 0
Australia
Other collaborator category [8] 277880 0
Government body
Name [8] 277880 0
Northern Area Mental Health Service
Address [8] 277880 0
Grattan Street
Parkville
Victoria 3050
Country [8] 277880 0
Australia
Other collaborator category [9] 277881 0
Charities/Societies/Foundations
Name [9] 277881 0
Neami Psychiatric Disability Rehabilitation and Support Service
Address [9] 277881 0
247-249 Rosanna Road
Rosanna
Victoria 3084
Country [9] 277881 0
Australia
Other collaborator category [10] 277882 0
Charities/Societies/Foundations
Name [10] 277882 0
beyondBlue
Address [10] 277882 0
PO Box 6100
Hawthorn West
Victoria 3122
Country [10] 277882 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290742 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 290742 0
Ethics committee country [1] 290742 0
Australia
Date submitted for ethics approval [1] 290742 0
Approval date [1] 290742 0
29/01/2014
Ethics approval number [1] 290742 0
CF13/3300120130017

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2 2 0 0
/AnzctrAttachments/365315-monash-medicine DOHMinisterAug2013final.pdf

Contacts
Principal investigator
Name 44318 0
A/Prof Darryl Maybery
Address 44318 0
Monash University
3 Ollerton Avenue
Moe
Victoria 3825
Country 44318 0
Australia
Phone 44318 0
+61 429358470
Fax 44318 0
Email 44318 0
dmaybery@gmail.com
Contact person for public queries
Name 44319 0
Clare Plozza
Address 44319 0
Monash University
3 Ollerton Avenue
Moe
Victoria 3825
Country 44319 0
Australia
Phone 44319 0
+61 3 5128 1000
Fax 44319 0
+61 3 5128 1080
Email 44319 0
clare.plozza@monash.edu
Contact person for scientific queries
Name 44320 0
Darryl Maybery
Address 44320 0
Monash University
3 Ollerton Avenue
Moe
Victoria 3825
Country 44320 0
Australia
Phone 44320 0
+61 429358470
Fax 44320 0
+61 3 5128 1080
Email 44320 0
dmaybery@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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