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Trial registered on ANZCTR


Registration number
ACTRN12616000460404
Ethics application status
Approved
Date submitted
1/04/2016
Date registered
8/04/2016
Date last updated
8/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the Let's Talk about Children recovery model for parents in Victorian mental health and family services: Phase 3
Scientific title
A randomised control trial of Let’s Talk About Children on the mental health recovery of parents with a mental illness: Phase 3.
Secondary ID [1] 288936 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Family related mental illness 296917 0
Depression 298288 0
Schizophrenia 298289 0
Anxiety 298290 0
Condition category
Condition code
Mental Health 297153 297153 0 0
Schizophrenia
Mental Health 297154 297154 0 0
Depression
Mental Health 297155 297155 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 practitioners 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 practitioner engages with the parent about the impact of their illness on their children. The mental health practitioner 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. This also involves the practitioner helping the parent to understand the impact of the mental illness on their children along with helping the parent to provide ongoing support to their children. The intervention is implemented in 3 sessions however with practitioner and parent agreement this is reduced to 2 sessions based on their judgement that the 3rd session is not required. Let's Talk sessions are logged by the treating practitioner. Sessions are commonly implemented for 60 minutes once per week. Practitioners 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 practitioner 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 practitioner.
Intervention code [1] 293373 0
Behaviour
Comparator / control treatment
During the wait list period the control group will continue to receive standard care from their treating clinician and will be offered the intervention after 6 months.
Control group
Active

Outcomes
Primary outcome [1] 297821 0
Recovery as measured by the Recovery Assessment Scale
Timepoint [1] 297821 0
Completed at baseline and post intervention (6 weeks post baseline) and 6 months after post intervention
Primary outcome [2] 297822 0
Parenting as measured by the Parenting Stress Scale
Timepoint [2] 297822 0
Completed at baseline and post intervention (6 weeks post baseline) and 6 months after post intervention
Primary outcome [3] 297823 0
Family functioning as measured by the Family Assessment Device
Timepoint [3] 297823 0
Completed at baseline and post intervention (6 weeks post baseline) and 6 months after post intervention
Secondary outcome [1] 322346 0
How often parent engages with children about mental illness as measured by frequency of engagement score
Timepoint [1] 322346 0
Completed at baseline and post intervention (6 weeks post baseline) and 6 months after post intervention
Secondary outcome [2] 322377 0
How a parent engages with the mental health practitioner as measured by the working alliance inventory as completed by the parent
Timepoint [2] 322377 0
Completed at baseline and post intervention (6 weeks post baseline) and 6 months after post intervention
Secondary outcome [3] 322572 0
Quality of Life as measured by the Assessment of Quality of Life (AQoL)-8D instrument
Timepoint [3] 322572 0
Completed at baseline and post intervention (6 weeks post baseline) and 6 months after post intervention

Eligibility
Key inclusion criteria
Clients of the participating services (adult mental health service, mental health community support service or family support service)
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 practitioner 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)
Practitioners with an interest in family sensitive practice will communicate interest to be trained in the Let’s Talk intervention and to participate in the research. Randomisation will occur at the practitioner level after the research team has obtained their consent and notified the researchers of potentially eligible parent-clients on their case load. Thus, practitioners will be randomly assigned to the Let’s Talk/intervention condition to be trained and deliver Let’s Talk to parents. The remaining eligible practitioners will be assigned to the wait list/control condition and trained in the intervention to deliver to parents at the completion of the research.

Parent-clients on the case load of consenting 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 – after completing Let’s Talk below (or equivalent time frame - an estimated 4-10 weeks after pre questionnaires) for wait list controls and then a third identical questionnaire package at follow-up (6 months after the post questionnaire package).

Following the completion of the first questionnaire package all participating practitioners will then be randomised to either: (1) wait list control group or (2) Let’s Talk intervention group to receive training in the intervention within a month. 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 administrative officer (based at a different site to the research team) will allocate the practitioner based on the computer generated random sequence (using SPSS). Allocation will involve contacting the holder of the allocation schedule who is “off-site” from the central administration team. 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.

Following this stage, parent-clients of trained Let’s Talk practitioners 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 Let’s Talk intervention from their practitioner. If the parent- client declines the Let’s Talk 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 non-trained (in Let's Talk) practitioner and will be informed about (and offered) Let's Talk as they complete the final follow up questionnaire following the training of their treating practitioner. 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. All parent-clients who complete questionnaires with receive a $20 supermarket voucher. Recruitment will occur over a 15 month period.
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=72 participants with Crit F=1.90 (using GPOWER 3.1, assuming 6 groups and 3 repetitions, a small effect size, an alpha of 5% and power of 95%) to be required. In addition we also undertook two further power calculations based on different effect size data from our pilot study (from analyses employing outcomes for different subscales from the parenting stress measure). The first indicated a minimum n=48 participants with Crit F=1.94 (assuming 6 groups and 3 repetitions based on an observed effect size of .09 (GPOWER effect size f of 0.31), an alpha of 5% and power of 95%). The second more conservative calculation indicated a minimum n=114 participants with Crit F=1.87 (assuming 6 groups and 3 repetitions based on an observed effect size of .036 (GPOWER effect size f of 0.19), an alpha of 5% and power of 95%).

The larger number of participants in the proposed study will account for parent drop out, to allow between group comparisons across sectors and for additional power due to the cluster design.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/12/2015
Date of last participant enrolment
Anticipated
23/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
192
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5529 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [2] 5530 0
The Northern Hospital - Epping
Recruitment hospital [3] 5531 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 5532 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [5] 5533 0
Maroondah Hospital - Ringwood East
Recruitment hospital [6] 5534 0
Albury Wodonga Health - Wodonga campus - Wodonga
Recruitment hospital [7] 5535 0
Northeast Health Wangaratta - Wangaratta

Funding & Sponsors
Funding source category [1] 293240 0
Government body
Name [1] 293240 0
Victorian Department of Health
Country [1] 293240 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton,
Victoria 3000
Country
Australia
Secondary sponsor category [1] 292039 0
University
Name [1] 292039 0
La Trobe University
Address [1] 292039 0
The Bouverie Centre
8 Gardiner St
Brunswick
Victoria 3056
Country [1] 292039 0
Australia
Secondary sponsor category [2] 292040 0
Other
Name [2] 292040 0
Parenting Research Centre
Address [2] 292040 0
5/232 Victoria Parade,
East Melbourne
Victoria 3002
Country [2] 292040 0
Australia
Secondary sponsor category [3] 292041 0
University
Name [3] 292041 0
Deakin University
Address [3] 292041 0
221 Burwood Hwy
Burwood
Victoria 3025
Country [3] 292041 0
Australia
Secondary sponsor category [4] 292042 0
University
Name [4] 292042 0
University of Melbourne
Address [4] 292042 0
Grattan Street
Parkville
Victoria 3010
Country [4] 292042 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294718 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 294718 0
Ethics committee country [1] 294718 0
Australia
Date submitted for ethics approval [1] 294718 0
Approval date [1] 294718 0
29/01/2014
Ethics approval number [1] 294718 0
CF13/3300120130017

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

Contacts
Principal investigator
Name 61930 0
Prof Darryl Maybery
Address 61930 0
Monash University
3 Ollerton Avenue
Moe
Victoria 3825
Country 61930 0
Australia
Phone 61930 0
+61429358470
Fax 61930 0
+69361281080
Email 61930 0
dmaybery@gmail.com
Contact person for public queries
Name 61931 0
Julie Irvine
Address 61931 0
Monash University
3 Ollerton Avenue
Moe
Victoria 3825
Country 61931 0
Australia
Phone 61931 0
+69361281000
Fax 61931 0
+69361281080
Email 61931 0
julie.irvine@monash.edu
Contact person for scientific queries
Name 61932 0
Darryl Maybery
Address 61932 0
Monash University
3 Ollerton Avenue
Moe
Victoria 3825
Country 61932 0
Australia
Phone 61932 0
+61429358470
Fax 61932 0
+69361281080
Email 61932 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDeveloping an Australian-first recovery model for parents in Victorian mental health and family services: A study protocol for a randomised controlled trial.2017https://dx.doi.org/10.1186/s12888-017-1357-4
N.B. These documents automatically identified may not have been verified by the study sponsor.