Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000857202
Ethics application status
Approved
Date submitted
29/09/2009
Date registered
1/10/2009
Date last updated
8/07/2021
Date data sharing statement initially provided
8/07/2021
Date results provided
8/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
CD-ROM Assisted Therapy for Treatment of Aggression
Scientific title
Using CD-ROM assisted therapy to reduce aggression in 7-14 year olds
Secondary ID [1] 304738 0
nil known
Universal Trial Number (UTN)
U1111-1111-0252
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aggression in children aged 7-14 years 251937 0
Condition category
Condition code
Mental Health 252119 252119 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The CD-ROM treatment entitled Face Your Problems involves a cognitive-behavioural treatment for reducing aggression in children over approximately 10-13 sessions (one per week of approximately 50 minutes duration) with a qualified therapist. The number of sessions will be addressed on a case-by-case basis by the therapist, with as many sessions as needed to achieve the session goals (i.e. parts of the session may be repeated if needed). The first two to three appointments will guide the child through a structured psycho-educational program on the CD ROM which focuses on teaching the child about: (i) perception and the need to look for clues in social situations (ii) the need for a 'thinking plan' to learn to cope (iii) the evaluation of different scenes with social problems. The last five to seven appointments utilizes the second part of the CD ROM which guides the child through a more intensive structured form of pro-social problem solving. The aim of the program is to over train the subject in the self-talk required for social problem solving with increasing practice in real world situations.
Intervention code [1] 241356 0
Treatment: Other
Comparator / control treatment
Treatment as Usual (standard treatment) will be conducted by the Child and Youth Mental Health Service and can involve various talking therapies or drug therapies
Control group
Active

Outcomes
Primary outcome [1] 253001 0
A score of 1 or 2 on the Children's Aggression Scale (CAS-Parent Rated) which measures the frequency and severity of aggressive behaviours
Timepoint [1] 253001 0
Baseline; 1 month; completion of treatment (3 months); 6 months; 12 months
Secondary outcome [1] 257770 0
Global improvement as measured by the Clinical Global Impressions Scale (rated by clinician, parent and child)
Timepoint [1] 257770 0
Baseline; 1 month; completion of treatment (3 months); 6 months; 12 months
Secondary outcome [2] 257771 0
General emotional and behaviorual functioning as measured by a reduction in score on the Strengths and
Difficulties Questionnaire
Timepoint [2] 257771 0
Baseline; 1 month; completion of treatment (3 months); 6 months; 12 months
Secondary outcome [3] 257772 0
Family functioning as measured by the Family Assessment Device-Parent Rated
Timepoint [3] 257772 0
Baseline; 1 month; completion of treatment (3 months); 6 months; 12 months

Eligibility
Key inclusion criteria
Between 7 and 14 years of age (inclusive); Diagnosis of oppositional defiant disorder or conduct disorder, as determined by clinical interview;
Presence of overt aggressive behaviours persisting for at least 6 months: either physical aggression directed towards others or objects, or verbal abuse;
Score of 4 or more (correlating to moderate severity of illness) on the Clinical Global Impressions – Severity subscale score;
Provision of consent from parent/carer and provision of assent from the child;
Sufficient English language to enable completion of research assessments and questionnaires
Minimum age
7 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non consent from either parent or child;
Pregnancy, breastfeeding, or plan to become pregnant/breastfeed within the time of the study;
Diagnosis of psychosis disorder, bipolar disorder, post-traumatic stress disorder or substance use disorder;
Diagnosis of autism or other severe developmental disorder;
Mental retardation of at least moderate severity (clinician assessed);
Significantly sub-average Intelligence Quotient (IQ) (clinician assessed);
Recent suicide attempt (previous month);
Acute unstable medical/psychiatric condition judged by clinician to require priority intervention or that contraindicates participation

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)
The presenting parent of children who meet the inclusion criteria will be invited to participate in the research by their clinician. Once they express interest in the project details will be forwarded to the Research Officers (ROs). On receipt of referral details the RO will contact the parent and mail the pre-assessment questionnaire booklet. Following completion of pre-assessment measures, the participants will be randomly assigned to one of two conditions (treatment or 'treatment as usual' control). Both the clinician who refers a participant to the study, and the research officers involved in the referral and later collection of data, will be unaware of which group the participant will be allocated to. . Concealment will be done using participant numbers sealed in opaque envelopes to be opened when full consent is obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A varying-block randomisation protocol will be used: varying block sizes of 4 and 6 (where there are even numbers of each treatment group represented every cycle of 4 or 6 participants) will be used to ensure that randomisation outcome cannot be predicted
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
1/10/2009
Actual
1/10/2009
Date of last participant enrolment
Anticipated
Actual
29/01/2018
Date of last data collection
Anticipated
Actual
28/03/2018
Sample size
Target
54
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19945 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 34647 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 243817 0
Hospital
Name [1] 243817 0
Mater Children's Hospital (MCH) Golden Casket Research Committee
Country [1] 243817 0
Australia
Funding source category [2] 309111 0
Hospital
Name [2] 309111 0
Children's Health Queensland , Child and Youth Mental Health Service
Country [2] 309111 0
Australia
Primary sponsor type
Hospital
Name
Kids in Mind Research
Address
Level 2, Potter Building,
41 Annerley Road,
South Brisbane,
4101
Country
Australia
Secondary sponsor category [1] 237166 0
None
Name [1] 237166 0
Address [1] 237166 0
Country [1] 237166 0
Other collaborator category [1] 885 0
Hospital
Name [1] 885 0
QLD Health Services District, Child and Youth Mental Health
Address [1] 885 0
The Institute for Child and Youth Mental Health,
Cnr Rogers and Water Streets, Spring Hill 4000
PO Box 1507, Fortitude Valley Qld 4006
Country [1] 885 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243948 0
Mater Hospital and Health Service District Human Research Ethics Committee (HREC)
Ethics committee address [1] 243948 0
Ethics committee country [1] 243948 0
Australia
Date submitted for ethics approval [1] 243948 0
10/06/2008
Approval date [1] 243948 0
12/12/2008
Ethics approval number [1] 243948 0
EC00332

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

Contacts
Principal investigator
Name 30340 0
Dr William Bor
Address 30340 0
Centre for Children's Health Research
62 Graham St
South Brisbane
Queensland
4101
Country 30340 0
Australia
Phone 30340 0
+61 404821775
Fax 30340 0
Email 30340 0
[email protected]
Contact person for public queries
Name 13587 0
William Bor
Address 13587 0
Level 6, Centre for Children's Health Research
62 Graham St
South Brisbane
Queensland
4101
Country 13587 0
Australia
Phone 13587 0
+61730681111
Fax 13587 0
+61 7 3163 1310
Email 13587 0
[email protected]
Contact person for scientific queries
Name 4515 0
William Bor
Address 4515 0
Centre for Children's Health Research
62 Graham St
South Brisbane
Queensland
4101
Country 4515 0
Australia
Phone 4515 0
+61730681111
Fax 4515 0
+61730697119
Email 4515 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The original study was not designed with data sharing as part of the protocol


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.