Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001296628
Ethics application status
Approved
Date submitted
12/11/2014
Date registered
11/12/2014
Date last updated
14/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Know and Grow: An investigation into parent and family involvement in eating disorder treatment.
Scientific title
For children and adolescents with eating disorders, parent skills training will be compared with treatment as usual, and social and clinical outcomes will be evaluated for both parents and children.
Secondary ID [1] 285633 0
None
Universal Trial Number (UTN)
U1111-1163-9479
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating Disorders 293475 0
Condition category
Condition code
Mental Health 293758 293758 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parent Skills Training Intervention, otherwise known as Collaborative Caring for Loved Ones with an Eating Disorder. This intervention uses parent training skills based on motivational interviewing, behavioural analysis, cognitive and interpersonal therapy, dialectical behavioural therapy, problem solving skills, and psychoeducation. It is delivered in a group therapuetic workshop face to face format with mental health practitioner over two consecutive days with a total of 12 hours of workshop content. Adherence will be measure with a trial specific questionnaire.
Intervention code [1] 290580 0
Treatment: Other
Intervention code [2] 290724 0
Behaviour
Comparator / control treatment
Treatment as Usual which means standard treatment at the study site delivered by a multidisciplinary team and includes medical and psychological care and education services.
Control group
Active

Outcomes
Primary outcome [1] 293558 0
Global Eating Disoprder Psychopathology using scores on the Eating Disorder Examination
Timepoint [1] 293558 0
Twelve Months
Primary outcome [2] 293719 0
Child Self esteem using scores on the Rosenberg Self Esteem Scale
Timepoint [2] 293719 0
Twelve Months
Primary outcome [3] 293720 0
Family Functioning measured by the Family Assessment Device and the Inventory of Parent and Peer Attachment
Timepoint [3] 293720 0
Twelve Monthes
Secondary outcome [1] 311351 0
Childhood medical status and measured by Body Mass Index, Body Fat percentage, mid upper arm circumference, ferritin, insulin-like growth factor and amennorhoea status (self and parent report) as measured and calculated by paediatrician during medical examination including laboratory blood tests and BODPOD assessments.
Timepoint [1] 311351 0
Twelve Months
Secondary outcome [2] 311656 0
Child levels of depression and anxiety as measured by the Children's Depression Inventory and the Multidimensional Anxiety Scale for Children
Timepoint [2] 311656 0
Twelve Months
Secondary outcome [3] 311657 0
Carer Distress as measured by the Depression, Anxiety and Stres Scale
Timepoint [3] 311657 0
Twelve monthes
Secondary outcome [4] 311658 0
Parent Care giving burden as measured by the Experience of Care giving Inventory
Timepoint [4] 311658 0
Twelve monthes
Secondary outcome [5] 311659 0
Quality of Life as measured by the Child Health Questionnaire and the Quality of life Enjoyment and Satisfaction Questionnaire
Timepoint [5] 311659 0
Twelve monthes
Secondary outcome [6] 311660 0
Expressed Emotion as measured by the Family Questionnaire
Timepoint [6] 311660 0
Twelve monthes

Eligibility
Key inclusion criteria
Child with eating disorder diagnosis
Engaged in treatment at the study site
between 8 and 16 years
Minimum age
8 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Child not living with parent
No Eating Disorder Diagnosis
Active major psychiatric disorder in child or parent
Non-english speaking child or parent

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To detect a large effect size (i.e. standardised group difference) on continuous outcome measures, a minimum total sample size of 52 (i.e. patients) is required. This sample would achieve 80% statistical power, at a conventional alpha level of .05, on a two-tailed test.General linear mixed modelling with SPSS will be used to analyse data involving continuous outcomes (i.e. global eating disorder psychopathology, percent body mass index). General linear mixed modelling accommodates between-group comparisons, multiple time points, and allows for the modelling of statistical covariates.To assess group differences on categorical outcomes (i.e., amenorrhoea status), chi square tests for independence will be conducted. It is unlikely there will be enough statistical power to test these outcomes, yet we will inspect the data nevertheless.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2016
Actual
Date of last participant enrolment
Anticipated
18/11/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3138 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 8887 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 290226 0
Charities/Societies/Foundations
Name [1] 290226 0
Princess Margaret Hospital Foundation
Country [1] 290226 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital for Children
Address
Roberts Road
Subiaco
6008
WA
Country
Australia
Secondary sponsor category [1] 288934 0
None
Name [1] 288934 0
Address [1] 288934 0
Country [1] 288934 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291927 0
Princess Margaret Hospital Ethics Committee
Ethics committee address [1] 291927 0
Ethics committee country [1] 291927 0
Australia
Date submitted for ethics approval [1] 291927 0
Approval date [1] 291927 0
20/10/2011
Ethics approval number [1] 291927 0

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

Contacts
Principal investigator
Name 52678 0
Ms Julie McCormack
Address 52678 0
Princess Margaret Hospital
Roberts Road
Subiaco 6008
WA
Country 52678 0
Australia
Phone 52678 0
+61 8 9340 7012
Fax 52678 0
Email 52678 0
[email protected]
Contact person for public queries
Name 52679 0
Julie McCormack
Address 52679 0
Princess Margaret Hospital
Roberts Road
Subiaco 6008
WA
Country 52679 0
Australia
Phone 52679 0
+61 8 9340 7012
Fax 52679 0
Email 52679 0
[email protected]
Contact person for scientific queries
Name 52680 0
Julie McCormack
Address 52680 0
Princess Margaret Hospital
Roberts Road
Subiaco 6008
WA
Country 52680 0
Australia
Phone 52680 0
+61 8 9340 7012
Fax 52680 0
Email 52680 0
[email protected]

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
No additional documents have been identified.