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Trial registered on ANZCTR


Registration number
ACTRN12617001472369
Ethics application status
Approved
Date submitted
13/10/2017
Date registered
18/10/2017
Date last updated
21/01/2020
Date data sharing statement initially provided
23/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An Integrated Family Intervention for Child Conduct Problems: How a parenting intervention for childhood behavioural problems influences and is influenced by epigenetic variation in children aged 3 to 8 years.

Scientific title
Assessing the impact of an Integrated Family Intervention for Child Conduct Problems on child behaviour outcomes, family adjustment and epigenetics in children aged 3 to 8 years.

Secondary ID [1] 293125 0
National Health and Medical Research Council (funding body) grant number: APP1123072
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child behavioural and emotional disorders 305086 0
Condition category
Condition code
Mental Health 304402 304402 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: The Integrated Family Intervention for Child Conduct Problems (Dadds & Hawes, 2006)
Program description and procedure: The program consists of 10 x 1 hour treatment sessions focusing on managing child aggression, non-compliance and disruptive behaviour. Parents are empowered to strengthen and develop strategies that encourage positive child behaviour by giving attachment rich positive reinforcement and rewards, and discourage challenging behaviour through the provision of consistent, attachment and emotionally neutral behaviour management strategies. The program also includes modules that address parental mental health, marital adjustment and family communication, and, additional modules to address specific concerns such as management of anxiety and worry, emotion regulation and school consultation.
Mode: The intervention is delivered face-to-face in an individual family format (not group).
Location: The program is delivered at the Child Behaviour Research Clinic.
The program is delivered by clinical psychologists, psychologists and provisionally registered psychologists under the supervision of senior clinicians.
Materials/resources: The program is delivered as per the therapist manual for The Integrated Family Intervention for Child Conduct Problems (Dadds & Hawes, 2006)
Intervention code [1] 299372 0
Behaviour
Intervention code [2] 299373 0
Treatment: Other
Comparator / control treatment
Non-randomised control wait-list for a sub-sample of participants. The duration of the wait-list control sub-sample is approximately 3 months.
Control group
Active

Outcomes
Primary outcome [1] 303638 0
Child adjustment and levels of disruptive behaviour (and symptom severity of other psychological problems) measured using the Diagnostic Interview Schedule for Children, Adolescents and Parents (DISCAP) for DSM-V based on (the DISCAP; Holland & Dadds, 1997).



Timepoint [1] 303638 0
1. Preliminary Assessment - 3 months prior to commencing treatment (for a sub-sample of participants) 2. Pre-treatment assessment 3. Immediate post treatment assessment (e.g., within a week of completing treatment) 4. Three month follow up assessment
Primary outcome [2] 303672 0
Behavioural and emotional adjustment as measured by the Total Difficulties score on the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997).
Timepoint [2] 303672 0
1. Preliminary Assessment - 3 months prior to commencing treatment (for a sub-sample of participants) 2. Pre-treatment assessment 3. Immediate post treatment assessment (e.g., within a week of completing treatment) 4. Three month follow up assessment
Primary outcome [3] 303674 0
Family functioning assessed using the Total Score for The Parenting and Family Adjustment Scales (PAFAS: Sanders, Morawska, Haslam, Filus, Fletcher) a brief parent-report measure for use in assessment of parenting skills and family relationships.
Timepoint [3] 303674 0
1. Pre-treatment assessment
2. Immediate post treatment assessment (e.g., within a week of completing treatment)
3. Three month follow up assessment
Secondary outcome [1] 339730 0
Secondary Outcome 1: Epigenetic change following treatment as assessed through
exploratory analyses of methylation levels on the following genes involved in neurodevelopment: Oxycontin receptor, DRD4, SERT1B, and cortisol receptor.

Timepoint [1] 339730 0
1. Preliminary Assessment - 3 months prior to commencing treatment (for a sub-sample of participants) 2. Pre-treatment assessment 3. Immediate post treatment assessment (e.g., within a week of completing treatment) 4. Three month follow up assessment
Secondary outcome [2] 339823 0
Parent adjustment assessed using the Parent Problem Checklist (Dadds & Powell, 1991) a brief questionnaire measuring parental adjustment and inter-parental conflict over child rearing issues.
Timepoint [2] 339823 0
1. Pre-treatment assessment
2. Immediate post treatment assessment (e.g., within a week of completing treatment)
3. Three month follow up assessment
Secondary outcome [3] 339824 0
Parent feelings towards the child assessed using the Parent Feelings Questionnaire (Deater-Deckard, 1996).
Timepoint [3] 339824 0
1. Pre-treatment assessment
2. Immediate post treatment assessment (e.g., within a week of completing treatment)
3. Three month follow up assessment

Eligibility
Key inclusion criteria
Children with conduct problems (DSM-V Oppositional Defiant Disorder and or Conduct Disorder) as assessed using the DISCAP V. We adhere to the National Institute of Mental Health (NIMH) guidelines that research into the externalising disorders is compromised by exclusion of the major and naturally occurring comorbidities, Thus ADHD, affective/anxiety disorders, learning problems, and mild autistic features are allowed if conduct problems are also present and the child is not receiving or is stabilised on psychoactive medication in relation to them at the time of assessment.

Fluency in English
Minimum age
2 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current diagnosis of a psychotic disorder
2. Diagnosis of ASD at a severity level greater than 1
3. Developmental delay (estimated at IQ < 70)
4. Major medical disorder that has significantly interfered with family or school life
5. Family involvement in current legal issues including child custody disputes

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A non-randomised control wait-list arm of the study was added to the study design after enrolment of approximately 150 participants.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/10/2017
Actual
23/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
179
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297750 0
Government body
Name [1] 297750 0
The National Health and Medical Research Council
Country [1] 297750 0
Australia
Primary sponsor type
Individual
Name
Professor Mark Dadds
Address
Griffith Taylor Building (A 19)
School of Psychology
The University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 296786 0
Individual
Name [1] 296786 0
Dr Meryn lechowicz
Address [1] 296786 0
Child Behaviour Research Clinic
Brain and Mind Centre
97 Church Street, Camperdown
Sydney NSW 2050
Country [1] 296786 0
Australia
Secondary sponsor category [2] 296790 0
Individual
Name [2] 296790 0
Associate Professor David Hawes
Address [2] 296790 0
Clinical Psychology Unit
Mallett Street Campus
The University of Sydney
NSW 2006 Australia
Country [2] 296790 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298813 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 298813 0
Ethics and Research Integrity
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 298813 0
Australia
Date submitted for ethics approval [1] 298813 0
Approval date [1] 298813 0
13/07/2017
Ethics approval number [1] 298813 0
HREC Project ID: 2017/539

Summary
Brief summary
The REAL Treatment project will investigate the inter-play between evidenced-based interventions that improve the child caregiving context, childhood behavioural outcomes, and, changes in DNA methylation of the major neurodevelopmental genes. 400 Children aged 2 to 8 years and their families will be recruited through the Sydney Child Behaviour Research Clinic over a 4 year period to participate in the REAL Treatment Study: A parenting Intervention for Child Conduct Problems. Families and the research team will form a supportive partnership to assess and monitor a child’s behavioural, emotional and neurodevelopmental progress, as well as parenting progress and family environment over the course of a 6 to 10 week tailored, evidenced-based parenting intervention to address child conduct problems.

Assessments will be taken prior to and directly after receipt of the intervention as well as at a three month follow-up review assessment. Assessment will cover areas including: Child adjustment and diagnostic status, caregiver/parent adjustment, family environment, engagement with and dose of intervention received, epigenetic assessment (buccal cell collection for methylation assessment) and neurodevelopmental assessment (examining processes of emotional attention and responsiveness to stimuli). Preliminary assessments will also be conducted with a sub-sample of participants who are expected to be on the wait-list for 3 months or more before commencing treatment. A multi-informant assessment method will be applied throughout the research protocol that includes gathering data from: parents/caregivers; clinical interviews; the use of standardized questionnaire and psychometric assessments; coding of observational data of child and family interaction activities; and, teacher/educator reports and completion of questionnaires.

We aim to a) confirm an emerging model of how epigenetic regulation of the major neurodevelopmental systems maps onto individual differences in comorbid symptom profiles before and after intervention; b) to examine how this regulation and mapping predicts individual differences in responsiveness of children to intervention that produces standardised and measurable improvements in the child caregiving environment; c) to examine how early intervention alters epigenetic regulation of the major neurodevelopmental systems and REAL (responsiveness, emotional attention and learning) phenomena, thus modifying risk versus protection for future development.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78310 0
Prof Mark Dadds
Address 78310 0
Griffith Taylor Building (A 19)
School of Psychology
The University of Sydney, NSW 2006
Country 78310 0
Australia
Phone 78310 0
+61 2 8627 4583
Fax 78310 0
Email 78310 0
mark.dadds@sydney.edu.au
Contact person for public queries
Name 78311 0
Dr Meryn Lechowicz
Address 78311 0
Child Behaviour Research Clinic
Brain and Mind Centre
97 Church Street, Camperdown
Sydney NSW 2050
Country 78311 0
Australia
Phone 78311 0
+612 9114 4326
Fax 78311 0
Email 78311 0
scbrc@sydney.edu.au
Contact person for scientific queries
Name 78312 0
Prof Mark Dadds
Address 78312 0
Griffith Taylor Building (A 19)
School of Psychology
The University of Sydney, NSW 2006
Country 78312 0
Australia
Phone 78312 0
+61 2 8627 4583
Fax 78312 0
Email 78312 0
mark.dadds@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD sharing specified


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
SourceTitleYear of PublicationDOI
EmbaseUsing Time-out for Child Conduct Problems in the Context of Trauma and Adversity: A Nonrandomized Controlled Trial.2022https://dx.doi.org/10.1001/jamanetworkopen.2022.29726
N.B. These documents automatically identified may not have been verified by the study sponsor.