Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000152729
Ethics application status
Approved
Date submitted
6/02/2013
Date registered
8/02/2013
Date last updated
11/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
'OCD? Not Me! Curtin On-line Obsessive-Compulsive Disorder Treatment for Young People
Scientific title
An open trial of a fully automated computer self-help cognitive-behavioural intervention for youth with Obsessive-Compulsive Disorder
Secondary ID [1] 281910 0
NIL
Universal Trial Number (UTN)
U1111-1139-2976
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive-Compulsive Disorder 288309 0
Condition category
Condition code
Mental Health 288663 288663 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8 modules of Self-Help Cognitive-Behavioural Therapy provided via a fully on-line automated program. Modules completed at pace of participant within a maximum time period of 2 months. Psychoeducation, behavioural experiments (exposure) and cognitive-restructring make up the intervention. Each module is a mixture of psychoeducation via written material and video vignettes along with interactive exercises and quizes to ensure concepts are learnt. Upon completion of each module an email is automatically generated back to the parent/guardian explaining the module completed and providing within the body of the email written information regarding helpful strategies to support the child in their treatment completion.
Intervention code [1] 286477 0
Treatment: Other
Comparator / control treatment
No Treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288809 0
Obsessive-Compulsive Symptoms assessed using the Childrens Yale-Brown Obsessive-Compulsive Scale
Timepoint [1] 288809 0
Participants will be assessed twice, initially at pre-intervention and then again following the intervention
Primary outcome [2] 288820 0
The Child OCD Impact Scale-Revised (COIS-R) to assess OCD-related functional impairment
Timepoint [2] 288820 0
Participants assessed twice, initially at pre-intervention and then again following the intervention
Secondary outcome [1] 301044 0
Self-esteem Scale: Self-esteem has been found to have strong relationships with levels of happiness and school achievement. This 10-item scale measures general self-esteem and has excellent reliability and validity (Rosenberg, 1979).
Timepoint [1] 301044 0
Participants will be assessed twice, initially at pre-intervention and then agian following the intervention
Secondary outcome [2] 301062 0
Strengths and Difficulties: Strengths and Difficulties Questionnaire (SDQ-S) (Goodman, 1999). The student version of the Extended Strengths & Difficulties Questionnaire (SDQ-S) (Goodman, 1999) will measure child reports of internalising problems. The SDQ-S, a 25-item scale measures internalizing & externalising symptoms, & the burden of these symptoms. It contains five 5-item subscales, hyperactivity, emotional symptoms (anxiety & depression), conduct problems, peer problems, & pro-social behaviour. The impact section includes social impairment in home life, friendships, classroom learning & leisure activities. Reliability has been established with internal consistency coefficients of .82 for the total scale & .75 for the emotional problems subscale.
Timepoint [2] 301062 0
Particiapnts assessed twice, at pre-intervention and then again following the intervention

Eligibility
Key inclusion criteria
Primary diagnosis of OCD and have a score of 5 or more on the Short OCD Screener (SOCS). This screening measure will be used to determine eligibility to complete the program. It consists of 7 items including two items that assess interference from symptoms. A score of 5 or greater indicates probable OCD.
Participants must be currently living in Australia.
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suicide risk, extreme O-C Symptoms

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Convenience sample of those individuals who wish to receive computer-based treatment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pre-post within-subjects design

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
1/10/2013
Date of last participant enrolment
Anticipated
1/06/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 286700 0
Government body
Name [1] 286700 0
Commonwealth Government
Country [1] 286700 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University
GPO Box U1987
Bentley
WA 6845
Country
Australia
Secondary sponsor category [1] 285471 0
None
Name [1] 285471 0
Address [1] 285471 0
Country [1] 285471 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288766 0
Curtin Human Research Ethics Committee
Ethics committee address [1] 288766 0
Curtin University
GPO Box U1987
Bentley
WA 6845
Ethics committee country [1] 288766 0
Australia
Date submitted for ethics approval [1] 288766 0
05/03/2013
Approval date [1] 288766 0
03/04/2013
Ethics approval number [1] 288766 0
HR45/2013

Summary
Brief summary
The overall goal of this project is to develop an online CBT based self-help program for children and adolescents with OCD which incorporates families and carers in the treatment plan. This will fill the current gap between psychoeducation only and high intensity face-to-face assessment and therapy. Consistent with the proposed actions of the research plan, this program will improve the support given to and build the resilience of families and carers of young people with OCD, expand community based youth mental health services, and provide an accessible and targeted treatment to those young people who do not require immediate high intensity intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37674 0
A/Prof Clare Rees
Address 37674 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Bentley WA 6845
Country 37674 0
Australia
Phone 37674 0
+61 8 9266 3442
Fax 37674 0
Email 37674 0
[email protected]
Contact person for public queries
Name 37675 0
A/Prof Clare Rees
Address 37675 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Bentley WA 6845
Country 37675 0
Australia
Phone 37675 0
+61 8 9266 3442
Fax 37675 0
Email 37675 0
[email protected]
Contact person for scientific queries
Name 37676 0
A/Prof Clare Rees
Address 37676 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Bentley WA 6845
Country 37676 0
Australia
Phone 37676 0
+61 8 9266 3442
Fax 37676 0
Email 37676 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.