Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001014044
Ethics application status
Approved
Date submitted
9/11/2010
Date registered
19/11/2010
Date last updated
22/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the efficacy and social validity of a manualised, family-based group Cognitive Behavioural Therapy for adolescents with high-functioning autism and comorbid anxiety disorder.
Scientific title
A randomised controlled trial on the effect of group cognitive behavioural therapy (CBT) to reduce anxiety in adolescents with high functioning autism spectrum disorder and comorbid anxiety disorder
Secondary ID [1] 253057 0
none
Universal Trial Number (UTN)
U1111-1117-8248
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 258621 0
Anxiety Disorder 258622 0
Condition category
Condition code
Mental Health 258766 258766 0 0
Autistic spectrum disorders
Mental Health 258831 258831 0 0
Depression
Mental Health 258832 258832 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group Cognitive Behavioural Therapy will be used including 12 sessions for adolescents and 12 concurrent parent education sessions. The adolescent sessions teach cognitive behavioural skills that are targeted to combat anxiety while additionally incorporating social skills and assertiveness training in order to specifically address core HFASD deficits. The parent sessions will provide psychoeducation, and assist them in understanding their adolescent’s anxiety and the homework activities. The first 15 minutes of each session will entail parents and adolescents working together, followed by an adolescent-only session (1 hour) and then a parent session (45 minutes). The sessions will be weekly for 9 weeks and then 2 additional sessions, one month apart. Each group will complete intervention within 6 months.
Intervention code [1] 257581 0
Behaviour
Intervention code [2] 257642 0
Treatment: Other
Comparator / control treatment
Waiting List group (these participants will receive treatment 6 months after the commencement of the CBT Intervention sessions).
Control group
Active

Outcomes
Primary outcome [1] 259625 0
Anxiety Disorders Interview Schedule for Children (ADIS-C/P; Silverman & Albano, 1996).
Timepoint [1] 259625 0
Intervention Group - Pre-Post (6 months) and Follow-up (6 months following completion of intervention)
Waiting List Group - Pre and Post (6 months)
Secondary outcome [1] 266282 0
The Social Skills Improvement System Rating Scales (Parent) (SSIS: RS (P);Gresham & Elliott, 1990)
Timepoint [1] 266282 0
Intervention Group - Pre-Post (6 months) and Follow-up (6 months following completion of intervention)
Waiting List Group - Pre and Post (6 months)
Secondary outcome [2] 266283 0
The Spence Children's Anxiety Scale for Parents/Child (SCAS: P/C; Nauta et al., 2004)
Timepoint [2] 266283 0
Intervention Group - Pre-Post (6 months) and Follow-up (6 months following completion of intervention)
Waiting List Group - Pre and Post (6 months)
Secondary outcome [3] 266284 0
The Beach Center Family Quality of Life Scale (FQOL; (Poston et al., 2003)
Timepoint [3] 266284 0
Intervention Group - Pre-Post (6 months) and Follow-up (6 months following completion of intervention)
Waiting List Group - Pre and Post (6 months)
Secondary outcome [4] 266285 0
The Short Mood and Feelings Questionnaire Parent/Child (SMFQ-P/C; Costello & Angold, 1987)
Timepoint [4] 266285 0
Intervention Group - Pre-Post (6 months) and Follow-up (6 months following completion of intervention)
Waiting List Group - Pre and Post (6 months)

Eligibility
Key inclusion criteria
Inclusion criteria for adolescents in this study will consist of: 1) a current clinical diagnosis of autism, Asperger's Disorder, or Pervasive Developmental Disorder – Not Otherwise Specified (PDD-NOS); 2) a diagnosis of at least one anxiety disorder; 3) aged between 12 and 18 years; 4) a verbal IQ above 70 (as assessed in previous testing, or, if the adolescent’s verbal abilities are questioned by the independent assessor at baseline, then based on the Wechsler Intelligence Scale for Children-IV administered by the independent assessor); 5) the ability to read English, and 6) not taking any anxiety medication or taking a stable dose of anxiety medication (i.e., at least one month at the same dosage prior to baseline assessment), and, if taking medication, agreement for this to be maintained throughout the study.
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if: 1) the adolescent is planning on participating in psychotherapy, social skills training, or behavioural intervention such as applied behavioural analysis over the course of the study; 2) the family will be involved in therapy or parenting classes; 3) the adolescent begins taking psychiatric medication or changes his or her dosage during the intervention period; or 4) the family is not able to participate in the intervention program.

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)
Participants will be randomly allocated to one of ten therapy groups and then randomly allocated to either a treatment or control group using a computer program. The person clinicians determining if the participant's are eligible for inclusion in the trial are unaware, when this decision is made, to which group the participant would be allocated. Allocation will be concealed using central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking 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
10/01/2011
Actual
16/07/2011
Date of last participant enrolment
Anticipated
Actual
1/08/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 12781 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 258035 0
University
Name [1] 258035 0
Curtin University
Country [1] 258035 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street
Bentley
Perth 6982
Western Australia
Country
Australia
Secondary sponsor category [1] 257225 0
None
Name [1] 257225 0
Address [1] 257225 0
Country [1] 257225 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260028 0
Curtin University HREC
Ethics committee address [1] 260028 0
Ethics committee country [1] 260028 0
Australia
Date submitted for ethics approval [1] 260028 0
Approval date [1] 260028 0
05/11/2010
Ethics approval number [1] 260028 0
HR127/2010

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

Contacts
Principal investigator
Name 31893 0
Ms Theresa Kidd
Address 31893 0
Curtin University School of Psychology and Speech Pathology GPO Box U1987 Perth, Western Australia 6845
Country 31893 0
Australia
Phone 31893 0
+61 0420482053
Fax 31893 0
Email 31893 0
[email protected]
Contact person for public queries
Name 15140 0
Theresa Kidd
Address 15140 0
Curtin University
School of Psychology and Speech Pathology
GPO Box U1987 Perth,
Western Australia 6845
Country 15140 0
Australia
Phone 15140 0
+61 0420482053
Fax 15140 0
Email 15140 0
[email protected]
Contact person for scientific queries
Name 6068 0
Theresa Kidd
Address 6068 0
Curtin University
School of Psychology and Speech Pathology
GPO Box U1987 Perth,
Western Australia 6845
Country 6068 0
Australia
Phone 6068 0
+61 0420482053
Fax 6068 0
Email 6068 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.