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Trial registered on ANZCTR


Registration number
ACTRN12613000736741
Ethics application status
Approved
Date submitted
2/07/2013
Date registered
3/07/2013
Date last updated
22/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a randomised control trial of a cognitive behavioural intervention for symptoms of depression in adolescents with autism spectrum disorders
Scientific title
For adolescents with high functioning autism spectrum disorders, will cognitive behavioural intervention, as compared to no intervention decrease symptoms of depression?
Secondary ID [1] 282766 0
Nil
Universal Trial Number (UTN)
U1111-1145-1943
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression
Autism Spectrum Disorders 289512 0
Condition category
Condition code
Mental Health 289838 289838 0 0
Depression
Mental Health 289839 289839 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a cognitive behavioural therapy administered in small groups (4-5 participants at a time). It consists of 10 weekly sessions with an 11th booster session 4 weeks after the 10th session. Each session will go for about an hour. The interventions are aimed at helping individuals with autism spectrum disorders identify negative emotional states and symptoms of depression and learn strategies to manage and potentially reduce their levels of depressive symptoms. During each session, participants will engage in a variety of tasks, including some that promote the identification of emotions, challenging negative thinking, and learning effective emotion regulation strategies.
Intervention code [1] 287436 0
Treatment: Other
Comparator / control treatment
Participants will be randomised into two groups, one group will participate in the intervention immediately, while the other will be a waitlist group. Those in the wait-list group will receive the program as soon as the intervention group finishes, which will be roughly two months following the initial session.
Control group
Active

Outcomes
Primary outcome [1] 289905 0
Mean Beck Depression Inventory Scores
Timepoint [1] 289905 0
Baseline, at 10 weeks post intervention commencement, and at 3 months post intervention finalisation.
Primary outcome [2] 289907 0
Mean Depression Anxiety Stress Scores (Depression subscale)
Timepoint [2] 289907 0
Baseline, at 10 weeks post intervention commencement, and at 3 months post intervention finalisation.
Secondary outcome [1] 303528 0
Mean Emotion Regulation Questionnaire Scores (Both Suppression and Reappraisal subscales).
Timepoint [1] 303528 0
Baseline, at 10 weeks post intervention commencement, and at 3 months post intervention finalisation.
Secondary outcome [2] 303529 0
Mean Toronto Alexithymia Scale Scores
Timepoint [2] 303529 0
Baseline, at 10 weeks post intervention commencement, and at 3 months post intervention finalisation.

Eligibility
Key inclusion criteria
Diagnosis of a high functioning autism spectrum disorder (e.g., Asperger's Syndrome) as verified by the Asperger syndrome (and high-functioning autism) diagnostic interview. Reporting moderate symptoms of depression or greater on the Depression Anxiety Stress Scale.
Minimum age
15 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of cognitive disability as indicated by the Wechsler Abbreviated Scale of Intelligence.

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)
Allocations are conducted after participants have been deemed eligible to participate in the study. Allocations will be made by a random sequence generator on the computer. As allocations made by the random sequence generator will be conducted after the participants have been deemed eligible to participate, this would mean allocation is not known when eligibility to participate is being evaluated. Therefore, allocation would be concealed at the time of evaluating eligibility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocations will be randomised using a computerised random sequence generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
For a power of 80% and a medium effect size, a sample of 32 participants per group were needed. To account for a potential 20% attrition, 40 participants per group were required. The planned analyses include:
To evaluate the intervention:
3 (time) x 2 (group) mixed factorial ANOVA (for BDI, DASS, TAS-20, suppression, and reappraisal).
To evaluate predictors of intervention success:
Correlations between intervention success and baseline measures will be conducted (including performance on a cognitive battery and a theory of mind task).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/07/2013
Actual
6/07/2013
Date of last participant enrolment
Anticipated
1/08/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 287537 0
Self funded/Unfunded
Name [1] 287537 0
Country [1] 287537 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072
Australia
Country
Australia
Secondary sponsor category [1] 286289 0
None
Name [1] 286289 0
Address [1] 286289 0
Country [1] 286289 0
Other collaborator category [1] 277510 0
Other
Name [1] 277510 0
Minds and Hearts
Address [1] 277510 0
u6, 88 Boundary St West End (Brisbane) QLD 4101
Country [1] 277510 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289516 0
University of Queensland: Behavioural & Social Sciences Ethical Review Committee
Ethics committee address [1] 289516 0
Ethics committee country [1] 289516 0
Australia
Date submitted for ethics approval [1] 289516 0
17/04/2013
Approval date [1] 289516 0
04/06/2013
Ethics approval number [1] 289516 0
2013000506

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

Contacts
Principal investigator
Name 41150 0
Mr Damian Santomauro
Address 41150 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072
Australia
Country 41150 0
Australia
Phone 41150 0
+61422282169
Fax 41150 0
Email 41150 0
d.santomauro@uq.edu.au
Contact person for public queries
Name 41151 0
Damian Santomauro
Address 41151 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072
Australia
Country 41151 0
Australia
Phone 41151 0
+61422282169
Fax 41151 0
Email 41151 0
d.santomauro@uq.edu.au
Contact person for scientific queries
Name 41152 0
Damian Santomauro
Address 41152 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072
Australia
Country 41152 0
Australia
Phone 41152 0
+61422282169
Fax 41152 0
Email 41152 0
d.santomauro@uq.edu.au

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.