Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000914561
Ethics application status
Approved
Date submitted
28/07/2015
Date registered
2/09/2015
Date last updated
4/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
E-health behavioural family intervention for treatment of conduct problems in children and adolescents.
Scientific title
Evaluation of online-based behavioural family intervention program for treatment of conduct problems in children and adolescents.
Secondary ID [1] 287159 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oppositional Defiant Disorder
 295725 0
Conduct Disorder 296025 0
Condition category
Condition code
Mental Health 296004 296004 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Online behavioural family intervention: Online based behavioural family intervention using the Integrated Family Intervention for Child Conduct Problems (Dadds & Hawes, 2006).

This program focuses on managing child aggression, non-compliance and disruptive behaviour. Parents are
taught to encourage good behaviour by giving positive reinforcement and rewards, and discourage bad behaviour through the provision of consistent, emotionally neutral punishment. This program has been adapted to an online based program whereby the information is presented in a modules accessed through a virtual clinic with guidance provided on a weekly basis by a clinical psychologist. Each module consists of a short video of a therapist outlining the strategies and techniques from the program.

Parents after completing pre-assessment will be given logins to access a virtual clinic. After they have logged in to the clinic parents will be able to access the modules. After watching the module, parents will be encouraged to implement the techniques discussed, they will also then receive a phone call from a clinical psychologist who will review the material from the module and also answer any questions and problem
solve difficulties. After this phone call, the next module in the program will be unlocked for them to view. There is a total of 6 modules in the program. Each module contains video content and also supplemented with written materials.

Duration: Each module goes for between 10-20 minutes and the phone call with the clinician will vary between 45-60 minutes. Each subsequent module in the program is unlocked and able to view after the parents speak to the clinician to review the information presented in the current module. Parents will be required to login to the program on a weekly
basis and at the end of the same week they will receive the phone call with the clinician. The program goes in total for 8 weeks (6 modules plus 2 review sessions). The first review session is a conducted over the phone with the parent (approximately 20-30 minutes). The second review session is also conducted over the phone with the parent (approximately 45-60 minutes). There are no modules for the review sessions.
Intervention code [1] 292431 0
Behaviour
Comparator / control treatment
Standard behaviour family intervention treatment: Parents will receive the behavioural family intervention using the Integrated Family Intervention program. This program focuses on managing child aggression, non-compliance and disruptive behaviour. Parents are taught to encourage good behaviour by giving positive reinforcement and rewards, and discourage bad behaviour through the provision of consistent, emotionally neutral punishment.

This program will be provided by clinical psychologist face to face in weekly sessions.

Duration: There is a total of 8 weekly sessions over 8 weeks.
Each session will go between 60-90 minutes and content and duration of sessions will match the intervention condition.
Control group
Active

Outcomes
Primary outcome [1] 295671 0
Primary Outcome: Levels of disruptive behavior.
Levels of disruptive behavior will be assessed in three ways:

1. DSM-IV-TR diagnostic status for Oppositional Defiant Disorder or
Conduct Disorder as determined by the Diagnostic Interview Schedule for Children, Adolescents and Parents (DISCAP; Johnson, Barrett, Dadds, Fox, & Shortt, 1999).

2. Oppositional and conduct symptom severity, also assessed with the
DISCAP.

3. Independent observations of disruptive behavior from video recordings of a ten minute free play procedure with parents and child. Videos will be coded using the FOS-VII coding schedule (Pasalich & Dadds, 2009). Videos will be coded for child non-compliance, criticisms, oppositionality, complaints and withdrawal. Both the consistency and intensity of variables are coded, along a 5-point scale ranging from 0 (no occurrence of the behaviour) to 4 (behaviour occurred a lot of the time and/or was of very high intensity).
Timepoint [1] 295671 0
Timepoint:

1. Pre-treatment assessment

2. Immediate post treatment assessment (e.g., within a week of completing treatment)

3. Three month follow up assessment
Primary outcome [2] 295672 0
Parental Stress levels:

Level of parental stress will be assessed based on scores on the
Parenting Stress Index (Abidin), this scale is designed to measure parental stress and dysfunctional parenting.
Timepoint [2] 295672 0
Timepoint:

1. Pre-treatment assessment

2. Immediate post treatment assessment (e.g., within a week of completing treatment)

3. Three month follow up assessment
Primary outcome [3] 295673 0
Parenting Behaviour:

Parenting Behaviour will be assessed using the Alabama Parenting
Questionnaire (APQ; Shelton, Frick & Wooton, 1196), which has been
designed to look at parenting behaviour related to conduct problems
Timepoint [3] 295673 0
Timepoint:

1. Pre-treatment assessment
2. Immediate post treatment assessment (e.g., within a week of
completing treatment)
3. Six month follow-up assessment
Secondary outcome [1] 316181 0
Parental Knowledge of Behaviour Management Principles.

Parent's knowledge of Behaviour Management Principles will be
assessed using a questionnaires adapted from O' Dell, Tarler-Benlolo,
and Flynn (1979) measure and is designed to assess parental
knowledge of behaviour management principles as they complete the program.
Timepoint [1] 316181 0
Timepoint:

After viewing each module or session (control condition) parents will complete a set of 10 questions.

Eligibility
Key inclusion criteria
1. Primary DSM-IV-TR diagnosis of ODD or CD.
2. Fluency in English.

Inclusion Criteria for Parent(s)/Caregivers:
1. Fluency in English.
Minimum age
3 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current diagnosis of a psychotic disorder
2. Primary autism
3. Developmental delay (estimated at IQ < 80)
4. Major medical disorder that has significantly interfered with family or school life.

There are no exclusion criteria for parent(s)/caregivers.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/08/2015
Actual
14/08/2015
Date of last participant enrolment
Anticipated
Actual
12/12/2016
Date of last data collection
Anticipated
Actual
16/06/2017
Sample size
Target
100
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291728 0
Government body
Name [1] 291728 0
Australian Research Council
Country [1] 291728 0
Australia
Primary sponsor type
Individual
Name
Professor Mark Dadds
Address
Room 526, Griffith Taylor (A19)
The University of Sydney
NSW 2006 Australia
Country
Australia
Secondary sponsor category [1] 290403 0
Individual
Name [1] 290403 0
Dr Sonia Sultan
Address [1] 290403 0
Room 103, Mallett Street Campus (M02F)
The University of Sydney
NSW 2006 Australia
Country [1] 290403 0
Australia
Other collaborator category [1] 278564 0
Individual
Name [1] 278564 0
Dr David Hawes
Address [1] 278564 0
Level 3, Room 310 Clinical Psychology Unit, Mallett Street Campus (M02F)
The University of Sydney
NSW 2006 Australia
Country [1] 278564 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293251 0
UNSW Human Research Ethics Committee (HREC)
Ethics committee address [1] 293251 0
Ethics committee country [1] 293251 0
Australia
Date submitted for ethics approval [1] 293251 0
Approval date [1] 293251 0
02/07/2015
Ethics approval number [1] 293251 0
HC13224

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

Contacts
Principal investigator
Name 59094 0
Prof Mark Dadds
Address 59094 0
Room 526, Griffith Taylor (A19)
The University of Sydney
NSW 2006 Australia
Country 59094 0
Australia
Phone 59094 0
+61286274583
Fax 59094 0
Email 59094 0
[email protected]
Contact person for public queries
Name 59095 0
Mark Dadds
Address 59095 0
Room 526, Griffith Taylor (A19)
The University of Sydney
NSW 2006 Australia
Country 59095 0
Australia
Phone 59095 0
+61286274583
Fax 59095 0
Email 59095 0
[email protected]
Contact person for scientific queries
Name 59096 0
Mark Dadds
Address 59096 0
Room 526, Griffith Taylor (A19)
The University of Sydney
NSW 2006 Australia
Country 59096 0
Australia
Phone 59096 0
+61286274583
Fax 59096 0
Email 59096 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.