Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000047897
Ethics application status
Approved
Date submitted
19/11/2020
Date registered
19/01/2021
Date last updated
19/01/2021
Date data sharing statement initially provided
19/01/2021
Date results provided
19/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Implementing and evaluating the uptake of family inclusive practice in adult eating disorders: A stepped care approach to working with families of adults affected by eating disorders.
Scientific title
Implementing and evaluating the uptake of family inclusive practice in adult eating disorders: A stepped care approach to working with families of adults affected by eating disorders.
Secondary ID [1] 302829 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eating disorders 319798 0
Condition category
Condition code
Mental Health 317726 317726 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions will be allocated via participant choice as appropriate for the consenting, adult patient sample, and will include outpatient treatment as usual comprising either:
- eating disorder day program in group format, or
- individualised cognitive behaviour therapy or
- specialist support clinical management for eating disorders
Where patients choose to family involvement and to participate in the family intervention in addition to any of the treatment programs above, study-specific written family orientation material and treatment information as well as general carer eating disorder support and education resources to assist in identifying and assessing current psychosocial needs of patients and carers will be provided. Carers who participate will be given study-specific written reading materials and details of online resources providing disorder specific psychoeducation including mental health first aid guidelines for eating disorders (https://mhfa.com.au/sites/default/files/MHFA_eatdis_guidelines_A4_2013.pdf), an eating disorders carers help kit (https://eatingdisorderscarerhelpkit.com.au/), and information about an understanding eating disorder recovery online program (https://butterfly.org.au/get-support/online-programs-education/) as well as links for collaborative carer skills training materials (https://thenewmaudsleyapproach.co.uk/). Patients and carers will be offered a face-to-face individualised family consultation delivered by a specialist family worker and cofacilitated by an individual outpatient therapist from the Queensland Eating Disorder Service. Family consultations can be held at any point in the individual's treatment program, for as long as they are current outpatient's of the service, and at timepoints as directed by the patient and as developmentally appropriate for the adult patient sample of the study. The family consultation meetings will involve discrete tasks across four stages within an overall framework of a 90 minute individualised meeting between the patient, the family members or other supports, the individual clinician and the family worker. The stages include welcoming participants, making introductions, and orienting participants to the session; distinguishing the main issues for work in the session including clarifying the priority of different needs and participant concerns; responding to the agreed areas via an appropriate approach depending on the identified need, for example, by providing psychoeducation or further information, facilitating communication about experiences, utilising a problem solving process, and or providing direction for next steps, resources or referral as appropriate; and finally closing the session by summarising the session and arranging a follow up contact with participants. See https://www.bouverie.org.au/support-for-services/single_session_family_consultation_practice_manual for more information. If indicated by continuing needs or further issues identified, information on other specialist interventions for families affected by eating disorders offered by a community service will be provided. Examples of further issues identified which would lead to a recommendation being provided for further services include relationship issues that extend beyond the effects of the eating disorder to multiple other domains and would benefit from generic couples counselling or ongoing family therapy, problems with life transitions, individual participant needs around personal growth and development, identity exploration, or mental health issues.
Intervention code [1] 319107 0
Treatment: Other
Comparator / control treatment
Outpatient treatment as usual comprising either eating disorder day program in group format, or individualised cognitive behaviour therapy or specialist support clinical management for eating disorders as determined by initial assessment and treatment recommendations provided by consultant psychiatrist, comprehensive pre-treatment specialist mental health clinician assessment and case formulation, and ongoing clinical supervision and multidisciplinary team review.
Control group
Active

Outcomes
Primary outcome [1] 325767 0
Uptake of treatment as usual plus adjunct family consultation session as assessed via data collected from entries in the clinical patient record and electronic chart review, and collated for study database.
Timepoint [1] 325767 0
At completion of study
Secondary outcome [1] 389080 0
Impact of family consultation session on frequency of major presenting problem as measured by the Problem Evaluation Survey using a 10-point scale where 1 indicates ‘never’ and 10 ‘all the time’.
Timepoint [1] 389080 0
Assessed once between 2 and 4 weeks post consultation session.
Secondary outcome [2] 389921 0
Impact of family consultation session on feelings of distress about the major presenting problem as measured by the Problem Evaluation Survey using a 10-point scale to indicate how upset/worried participants were about the problem where 1 indicates ‘Not at all’ and 10 ‘As worried as I could possibly be’.
Timepoint [2] 389921 0
Assessed once between 2 and 4 weeks post consultation session.
Secondary outcome [3] 389922 0
Impact of family consultation session on disturbance experienced from the major presenting problem as measured by the Problem Evaluation Survey using a 10-point scale to indicate how much the problem is interfering in participant’s lives where 1 indicates ‘Not at all’ and 10 ‘Dominating my life completely’.
Timepoint [3] 389922 0
Assessed once between 2 and 4 weeks post consultation session.
Secondary outcome [4] 389923 0
Impact of family consultation session on confidence to deal with the major presenting problem as measured by the Problem Evaluation Survey using a 10-point scale to indicate how confident participants feel in dealing with the problem where 1 indicates ‘Not at confident’ and 10 ‘Extremely confident’.
Timepoint [4] 389923 0
Assessed once between 2 and 4 weeks post consultation session.

Eligibility
Key inclusion criteria
Current adult (i.e. >18 years) patient or family member of the Queensland Eating Disorder Service outpatient program able to identify at least one informal support person or carer who can be contacted during the outpatient treatment program.
Ability and or willingness to provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current adult patient with identification of medical risk during outpatient treatment and no longer cleared to continue with clinical care the QuEDS outpatient program by a medical professional.
Patient or carer not fluent in written and oral English.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/09/2018
Date of last participant enrolment
Anticipated
Actual
16/09/2019
Date of last data collection
Anticipated
Actual
31/03/2020
Sample size
Target
40
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 307251 0
Government body
Name [1] 307251 0
Australian Government, Department of Education and Training
Country [1] 307251 0
Australia
Funding source category [2] 307253 0
Hospital
Name [2] 307253 0
Royal Brisbane & Women’s Hospital
Country [2] 307253 0
Australia
Primary sponsor type
Government body
Name
Queensland Eating Disorder Service
Address
QuEDS
c/ 2 Finney Road
Indooroopilly, QLD 4068
Country
Australia
Secondary sponsor category [1] 307870 0
University
Name [1] 307870 0
University of Queensland
Address [1] 307870 0
c/ University of Queensland Graduate School
Level 6, John Hines Building (62)
The University of Queensland
St Lucia QLD 4072
Country [1] 307870 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307346 0
RBWH Human Research Ethics Committee
Ethics committee address [1] 307346 0
Ethics committee country [1] 307346 0
Australia
Date submitted for ethics approval [1] 307346 0
18/06/2018
Approval date [1] 307346 0
09/08/2018
Ethics approval number [1] 307346 0
HREC/18/QRBW/365
Ethics committee name [2] 307348 0
University of Queensland Human Research Ethics Committee
Ethics committee address [2] 307348 0
Ethics committee country [2] 307348 0
Australia
Date submitted for ethics approval [2] 307348 0
17/08/2018
Approval date [2] 307348 0
23/08/2018
Ethics approval number [2] 307348 0
2018001740

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

Contacts
Principal investigator
Name 106918 0
Ms Carmel Fleming
Address 106918 0
Queensland Eating Disorder Service
2 Finney Road, Indooroopilly QLD 4068
Country 106918 0
Australia
Phone 106918 0
+61 07 31007500
Fax 106918 0
Email 106918 0
[email protected]
Contact person for public queries
Name 106919 0
Carmel Fleming
Address 106919 0
Queensland Eating Disorder Service
2 Finney Road, Indooroopilly QLD 4068
Country 106919 0
Australia
Phone 106919 0
+61 07 31007500
Fax 106919 0
Email 106919 0
[email protected]
Contact person for scientific queries
Name 106920 0
Carmel Fleming
Address 106920 0
Queensland Eating Disorder Service
2 Finney Road, Indooroopilly QLD 4068
Country 106920 0
Australia
Phone 106920 0
+61 07 31007500
Fax 106920 0
Email 106920 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only aggregate group participant data will be available in accordance with Queensland Health policy.


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
No additional documents have been identified.