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Trial registered on ANZCTR


Registration number
ACTRN12611000901909
Ethics application status
Approved
Date submitted
21/08/2011
Date registered
24/08/2011
Date last updated
13/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Transdiagnostic versus Disorder-Specific, Internet-Based Cognitive Behaviour Therapy (CBT) for Social Phobia in Young People
Scientific title
Is Disorder-Specific CBT more effective than Transdiagnostic CBT in reducing social phobia in the online-delivered treatment of socially phobic children and adolescents?
Secondary ID [1] 262888 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social phobia among children and adolescents 270616 0
Condition category
Condition code
Mental Health 270783 270783 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Generic/Transdiagnostic intervention includes CBT anxiety management strategies including: psychoeducation, relaxation training, recognition of the physiological symptoms of anxiety, cognitive strategies of coping self-talk and cognitive restructuring, graded exposure, problem solving, and self-reinforcement. Parent sessions also teach anxiety management skills, in addition to parenting strategies to empower parents to help their child implement anxiety management skills.

The intervention comprises ten, one-hour online youth sessions and five, online one-hour parent sessions completed over a 12-week period. Booster sessions are completed at one- and three-months following treatment by both the young person and his/her parent(s).

Sessions are designed to be engaging, interactive, and age-appropriate. Eye-catching graphics, sounds, games and quizzes are used to maintain the youths’ level of interest. Information is presented through interactive exercises and followed by quizzes that check for correct understanding and provide personalized corrective or positive feedback through pop up messages. The content of the intervention is designed to meet the developmental and cognitive level of youths, with age-appropriate scenarios, examples, and activities (example situations include school exams, job interviews, dating, and oral presentations).

The program is (minimally) therapist-assisted, rather than self-help. Each family is assigned an online therapist (BRAVE Trainer) who monitors their progress through the program and provides brief email feedback following each session. At no stage do any participants have face-to-face contact with their therapist and all other contact (i.e., email or phone) was minimal. Clinician contact is restricted to brief, weekly emails. Most other contact with the ‘online therapist’ is computer generated. Client responses to all session and homework activities are stored in an administrator section of the program and can be viewed by the therapist to guide the content of the weekly email. In addition, automated computer-generated emails are sent on behalf of the online therapist to congratulate participants for completion of sessions and personalized emails are sent to provide feedback about responses to quiz tasks. Personalized automated reminder emails are sent to advise when the next session is available for completion, or to provide prompts if not completed by the due date. The first session also includes a picture of the therapist, and some brief biographical information about them, to which the client responds by providing information about themselves.

The wait list control condition will complete the pre-treatment assessment and will then be reassessed after 12-weeks. After this point they will be offered treatment by the research team, using the transdiagnostic, standard treatment approach.
Intervention code [1] 269241 0
Behaviour
Intervention code [2] 269257 0
Treatment: Other
Comparator / control treatment
There are two active treatments (transdiagnostic vs disorder specific) and a wait list control condition

The disorder specific approach is identical in length and form of delivery to the transdiagnositic approach described above but the information, examples, and strategies will be specifically targeted towards social phobia. For example, the disorder specific program will involve social skills and assertiveness training, whereas the transdiagnostic program will not. Even for sessions whereby the topic (e.g., psychoeducation) is the same across the two programs, the information, examples and explanations will be different. The disorder specific intervention comprises ten, one-hour online youth sessions and five, online one-hour parent sessions completed over a 12-week period. Booster sessions are completed at one- and three-months following treatment by both the young person and his/her parent(s).

The wait list control condition will complete the pre-treatment assessment and will then be reassessed after 12-weeks. After this point they will be offered treatment by the research team, using the transdiagnostic, standard treatment approach.
Control group
Active

Outcomes
Primary outcome [1] 279478 0
Primary outcome measure includes "blind", independent clinical diagnostic interview for anxiety disorders and clinician severity rating of diagnosis using Anxiety Disorders Interview Schedule for DSM-IV: Child and Parent versions (ADIS-C/P)
Timepoint [1] 279478 0
Pre-treatment
12-weeks
6-month follow-up
12-month follow-up
Primary outcome [2] 279479 0
Overall adaptive functioning using the Childrens Global Assessment Scale. (CGAS: Schaffer et al., 1983). The CGAS provides a single global rating of functioning, assigned to the youth by the independent, interviewing clinician, on a scale of 0 to 100, where lower scores indicate poorer functioning. A rating is given based on the child or adolescent?s most impaired level of general functioning for the specified time period by selecting the lowest level which describes his/her functioning on a hypothetical continuum of health-illness, benchmarked against anchor points in a descriptive glossary.
Timepoint [2] 279479 0
Pre-treatment
12-weeks
6-month follow-up
12-month follow-up
Secondary outcome [1] 287717 0
Internalizing problems using the Child Behaviour Checklist and Youth Self-Report form - Achenbach
Timepoint [1] 287717 0
Pre-treatment
12-weeks
6-month follow-up
12-month follow-up
Secondary outcome [2] 287718 0
Secondary outcomes include parent and youth reports of symptoms of social phobia using the
Social Phobia and Anxiety Beidel, D.C., S.M. Turner, and T.L. Morris, Social Phobia & Anxiety Inventory for Children
(SPAI-C), 1998. Canada: Multi-Health Systems Inc.
Timepoint [2] 287718 0
Pre-treatment
12-weeks
6-month follow-up
12-month follow-up
Secondary outcome [3] 287719 0
Vignette-based measures of threat
perception and negative cognitions as per Muris et al
Timepoint [3] 287719 0
Pre-treatment
12-weeks
6-month follow-up
12-month follow-up
Secondary outcome [4] 287720 0
Therapy compliance measures: Computer generated: number of sessions completed; frequency of sessions; number and
quality of completed homework assignments; number and quality of session activities
completed; time spent on sessions.
Timepoint [4] 287720 0
After each session
Secondary outcome [5] 287760 0
Assessment of interpersonal skills will be completed by the young person and their parent(s) using the Inventory for Children and Social Skills Questionnaire.

From - Spence, S.H., Social Skills Training: Enhancing Social Competence with Children and
Adolescents, 1995. Windsor, Berkshire, England: NFER-NELSON.
Timepoint [5] 287760 0
Pre-treatment
12-weeks
6-month follow-up
12-month follow-up
Secondary outcome [6] 323785 0
Post Event Processing: This is a cognitive process in which individuals think about the negative aspects of their performance after the event. The Measure use is the Post Event Processing Questionnaire. From:
McEvoy, P. M., & Kingsep, P. (2006). The post-event processing questionnaire in a clinical sample with social phobia. Behaviour Research and Therapy, 44(11), 1689-1697.
Timepoint [6] 323785 0
Pre; 12-weeks; 6 month follow-up; 12 month follow-up

Eligibility
Key inclusion criteria
Children and adolescents will be included in the study if they meet DSM-IV criteria for a primary diagnosis of social phobia with a clinical severity rating (CSR) of at least 4 (on a 0-8 scale). Comorbidity with other anxiety disorders and externalising disorders will be permissible as long as the social phobia is considered primary. Families must have access to a suitable computer and the internet, and be willing to participate in any of the three conditions.
Minimum age
7 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
As the internet program requires a minimum reading age of 8 years, children with an identified intellectual handicap or
learning disability will not be included. Children with a pervasive developmental disorder will also be excluded. For ethical reasons pertaining to the danger of potential self-harm, youngsters with clinical levels of depression (Clinician Severity Rating of 4 or higher on a 0-8 scale on the ADIS-C/P) will not be included in the program and will be referred elsewhere for assistance.

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)
Families will be recruited Australia-wide through referrals from general practitioners, mental health professionals, school guidance officers, and media publicity. Self referrals
will be accepted. Referrals will be screened by telephone using a standard screening interview in order to ascertain broad inclusion criteria. Following informed consent, the child/adolescent and a parent will complete a structured diagnostic interview (the ADIS-C/P) to determine clinical status. Eligible children will then be randomly assigned to one of three conditions (one of the two treatment conditions or the wait list).
Assessors will be trained clinical interviewers who will be independent of other aspects of the study and blind to allocated condition.
Random assignment of participants to conditions will be conducted using a computer generated random number sequence. The clinician who will make the judgement regarding acceptance into the trial will not be aware of the condition to which the client would subsequently be allocated to, thus allocation will be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence will be used for allocation of participants to one of three conditions
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will be followed- up over time.
The study will also enable us to examine predictors of therapy outcome, such as initial severity of symptoms, gender and age of child.

Mixed model, 4 repeated measures, 3 conditions.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2011
Actual
2/07/2012
Date of last participant enrolment
Anticipated
1/08/2014
Actual
1/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
Final
132
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 269713 0
Government body
Name [1] 269713 0
NHMRC
Country [1] 269713 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Griffith University
Nathan campus
Kessels Rd., Nathan
QLD 4111
Country
Australia
Secondary sponsor category [1] 268753 0
University
Name [1] 268753 0
University of Queensland
Address [1] 268753 0
University of Queensland St Lucia
Brisbane
Queensland
QLD 4067
Country [1] 268753 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271678 0
Griffith University HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 271678 0
Ethics committee country [1] 271678 0
Australia
Date submitted for ethics approval [1] 271678 0
01/11/2010
Approval date [1] 271678 0
18/11/2010
Ethics approval number [1] 271678 0
PSY/E9/10/HREC

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

Contacts
Principal investigator
Name 33055 0
Prof Professor Susan H. Spence
Address 33055 0
Griffith University, Mount Gravatt Campus
Australian Institute of Suicide Research and Prevention
176 Messines Ridge Road
Mt Gravatt, Qld
4122
Country 33055 0
Australia
Phone 33055 0
+ 61 07 373 53382
Fax 33055 0
Email 33055 0
s.spence@griffith.edu.au
Contact person for public queries
Name 16302 0
Professor Susan H Spence
Address 16302 0
Griffith University, Mount Gravatt Campus
Australian Institute of Suicide Research and Prevention
176 Messines Ridge Road
Mt Gravatt, Qld
4122
Country 16302 0
Australia
Phone 16302 0
+ 61 07 373 53382
Fax 16302 0
+61 7 37357507
Email 16302 0
s.spence@griffith.edu.au
Contact person for scientific queries
Name 7230 0
Professor Susan H Spence
Address 7230 0
Griffith University, Mount Gravatt Campus
Australian Institute of Suicide Research and Prevention
176 Messines Ridge Road
Mt Gravatt, Qld
4122
Country 7230 0
Australia
Phone 7230 0
+ 61 07 373 53382
Fax 7230 0
+61 7 37357507
Email 7230 0
s.spence@griffith.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

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