Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000191897
Ethics application status
Approved
Date submitted
10/02/2012
Date registered
14/02/2012
Date last updated
4/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
E-health behavioural family interaction program for treatment of conduct problems in children
Scientific title
Evaluation of online-based behavioural family interaction program for treatment of conduct problems in children
Secondary ID [1] 279865 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oppositional Defiant Disorder 285773 0
Conduct Disorder 285807 0
Condition category
Condition code
Mental Health 285941 285941 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 6 weeks.
Intervention code [1] 284188 0
Behaviour
Intervention code [2] 284263 0
Treatment: Other
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 6 weekly sessions over 6 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] 286477 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] 286477 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
Primary outcome [2] 286495 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 parenting stress and dysfunctional parenting.
Timepoint [2] 286495 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
Primary outcome [3] 286496 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] 286496 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] 296016 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] 296016 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
11 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
1/04/2012
Actual
4/11/2013
Date of last participant enrolment
Anticipated
Actual
10/08/2017
Date of last data collection
Anticipated
Actual
31/01/2018
Sample size
Target
100
Accrual to date
Final
148
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 284672 0
Government body
Name [1] 284672 0
Australian Research Council
Country [1] 284672 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] 283577 0
Individual
Name [1] 283577 0
Christina Thai
Address [1] 283577 0
Room 104
Child Behaviour Research Clinic
Mallett Street Campus (M02K)
97 Church Street
The University of Sydney, Camperdown
NSW 2006 Australia
Country [1] 283577 0
Australia
Other collaborator category [1] 260527 0
Individual
Name [1] 260527 0
Dr David Hawes
Address [1] 260527 0
Level 3, Room 310
Clinical Psychology Unit
M02F - Mallett Street Campus
The University of Sydney
NSW 2006 Australia
Country [1] 260527 0
Australia
Other collaborator category [2] 260528 0
Individual
Name [2] 260528 0
Associate Professor John Brennan
Address [2] 260528 0
Sydney Children's Hospital
Mental Health Inpatient Unit
High Street
Randwick NSW 2031
Country [2] 260528 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286675 0
University of NSW HREC
Ethics committee address [1] 286675 0
Ethics committee country [1] 286675 0
Australia
Date submitted for ethics approval [1] 286675 0
06/03/2012
Approval date [1] 286675 0
10/09/2013
Ethics approval number [1] 286675 0
Ethics committee name [2] 297306 0
University of Sydney HREC
Ethics committee address [2] 297306 0
Ethics committee country [2] 297306 0
Australia
Date submitted for ethics approval [2] 297306 0
28/09/2015
Approval date [2] 297306 0
16/11/2015
Ethics approval number [2] 297306 0
2015/822

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

Contacts
Principal investigator
Name 33729 0
Prof Mark Dadds
Address 33729 0
Professor of Psychology
NHMRC Principal Research Fellow
Director, Sydney Child Behaviour Research Clinic

School of Psychology
University of Sydney NSW 2006
Country 33729 0
Australia
Phone 33729 0
+61286275873
Fax 33729 0
Email 33729 0
[email protected]
Contact person for public queries
Name 16976 0
Christina Thai
Address 16976 0
M02k Brain and Mind Centre University of Sydney Camperdown NSW 2050
Country 16976 0
Australia
Phone 16976 0
61286275873
Fax 16976 0
Email 16976 0
[email protected]
Contact person for scientific queries
Name 7904 0
Professor Mark Dadds
Address 7904 0
Room 526 Griffith Taylor University of Sydney NSW 2006
Country 7904 0
Australia
Phone 7904 0
61286275873
Fax 7904 0
Email 7904 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.