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Trial registered on ANZCTR


Registration number
ACTRN12610000216011
Ethics application status
Approved
Date submitted
11/03/2010
Date registered
16/03/2010
Date last updated
6/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of Two Forms of Family-Based Treatment for Adolescent Anorexia Nervosa
Scientific title
A Randomised Controlled Trial of Two Forms of Family-Based Treatment and the Effect on Percent Ideal Body Weight and Eating Disorders Symptoms in Adolescent Anorexia Nervosa
Secondary ID [1] 1481 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia Nervosa 256952 0
Condition category
Condition code
Mental Health 257092 257092 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Family-based treatment (FBT). In this treatment, the whole family attends 18 50-minute sessions with a trained mental health clinician over 6 months. In the early part of treatment, parents are assisted in finding their own ways to help their child overcome their unhealthy eating habits. This is done through education about the seriousness of eating disorders, as well as coaching parents about how they may go about taking control of their adolescent’s eating. Once symptoms are under control and weight restoration is nearing completion, parents gradually hand eating decisions back to the adolescent. General adolescent issues, such as learning to function more on his/her own, are discussed toward the end of treatment.
Intervention code [1] 256128 0
Treatment: Other
Comparator / control treatment
Parent-focused treatment (PFT). In this treatment, the parent(s) and the adolescent are seen separately for 18 50-minute sessions over 6 months. The therapist sees only the parent(s) and works through the same phases of treatment as in standard FBT. The adolescent is seen by a trained nurse for medical management and supportive counselling.
Control group
Active

Outcomes
Primary outcome [1] 257983 0
Percent ideal body weight calculated from height and weight as assessed with standardised stadiometer and scales
Timepoint [1] 257983 0
Baseline, trhoughout treatment, end of treatment, 6 month follow up, 12 month follow up
Secondary outcome [1] 263534 0
Eating disorders symptoms as assessed by the Eating Disorder Examination
Timepoint [1] 263534 0
Baseline, mid-treatment, end of treatment, 6 month follow up, 12 month follow up

Eligibility
Key inclusion criteria
Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis of anorexia nervosa (excluding amenorrhea) or eating disorder not otherwise specified-anorexia nervosa type; living with parents or legal guardians; ideal body weight less than or equal to 90%; medically stable for outpatient treatment
Minimum age
12 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychotic disorder;drug/alcohol dependence; physical condition known to influence weight; previous treatment with FBT

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
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2076 0
The Royal Childrens Hospital - Parkville

Funding & Sponsors
Funding source category [1] 256628 0
Charities/Societies/Foundations
Name [1] 256628 0
Baker Foundation
Address [1] 256628 0
GPO Box 389
Melbourne VIC 3000
Country [1] 256628 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital
Address
Flemington Road
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 255916 0
University
Name [1] 255916 0
University of Melbourne
Address [1] 255916 0
Department of Paediatrics Royal Children's Hospital Flemington Road Parkville VIC 3052
Country [1] 255916 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258656 0
Royal Children's Hospital HREC
Ethics committee address [1] 258656 0
Royal Children's Hospital
PARKVILLE VIC 3052
Ethics committee country [1] 258656 0
Australia
Date submitted for ethics approval [1] 258656 0
09/04/2010
Approval date [1] 258656 0
05/07/2010
Ethics approval number [1] 258656 0
30035

Summary
Brief summary
The purpose of this study is to identify an efficacious outpatient treatment for adolescents with anorexia nervosa. Evidence suggests that family-based treatment (FBT) is efficacious. However, FBT is not helpful for all families as it can be complex and requires all family members to be involved. Therefore, this project will examine whether another form of FBT, called Parent-focused Treatment, is a feasible alternative to standard FBT. To do this we will compare the outcomes for families who take part in standard FBT to those of families who take part in Parent-focused Treatment (PFT).
Trial website
Trial related presentations / publications
Le Grange D., Hughes E.K., Court A., Yeo M., Crosby C., & Sawyer S. (2016). Randomized clinical trial of parent-focused treatment and family-based treatment for adolescent anorexia nervosa. Journal of the American Academy of Child and Adolescent Psychiatry, 55(8): 683-692. doi: 10.1016/j.jaac.2016.05.007
Hughes, E.K., Le Grange D., Court, A., Yeo, M., Crosby, R., & Sawyer, S.M. (2016, August). Findings from a randomized clinical trial of parent-focused treatment for adolescent anorexia nervosa. The 14th Annual Conference of the Australian and New Zealand Academy of Eating Disorders. Christchurch, New Zealand.
Public notes

Contacts
Principal investigator
Name 30918 0
Prof Susan Sawyer
Address 30918 0
Royal Children's Hospital, Flemington Road Parkville VIC 3052
Country 30918 0
Australia
Phone 30918 0
+61 3 9345 6597
Fax 30918 0
Email 30918 0
susan.sawyer@rch.org.au
Contact person for public queries
Name 14165 0
Dr Libby Hughes
Address 14165 0
Centre for Adolescent Health Royal Children's Hospital Flemington Road Parkville VIC 3052
Country 14165 0
Australia
Phone 14165 0
+61 3 9345 4738
Fax 14165 0
+61 3 9345 6273
Email 14165 0
Libby.Hughes@rch.org.au
Contact person for scientific queries
Name 5093 0
Dr Libby Hughes
Address 5093 0
Centre for Adolescent Health Royal Children's Hospital Flemington Road Parkville VIC 3052
Country 5093 0
Australia
Phone 5093 0
+61 3 9345 4738
Fax 5093 0
Email 5093 0
Libby.Hughes@rch.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary