ANZCTR - Registration

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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]

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

Condition category

Condition code

Mental Health

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]

Behaviour

Intervention code [2]

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]

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]

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]

Behavioural and emotional adjustment as measured by the Total Difficulties score on the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997).

Timepoint [2]

Primary outcome [3]

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]

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]

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]

Secondary outcome [2]

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]

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]

Parent feelings towards the child assessed using the Parent Feelings Questionnaire (Deater-Deckard, 1996).

Timepoint [3]

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?

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]

Government body

Name [1]

The National Health and Medical Research Council

Address [1]

The National Health and Medical Research Council
NHMRC Research Administration Section
GPO Box 1421 Canberra City ACT 2601

Country [1]

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]

Individual

Name [1]

Dr Meryn lechowicz

Address [1]

Child Behaviour Research Clinic
Brain and Mind Centre
97 Church Street, Camperdown
Sydney NSW 2050

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Associate Professor David Hawes

Address [2]

Clinical Psychology Unit
Mallett Street Campus
The University of Sydney
NSW 2006 Australia

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney Human Research Ethics Committee

Ethics committee address [1]

Ethics and Research Integrity
Margaret Telfer Building (K07)
University of Sydney
NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/07/2017

Ethics approval number [1]

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

Prof Mark Dadds

Address

Griffith Taylor Building (A 19)
School of Psychology
The University of Sydney, NSW 2006

Country

Australia

Phone

+61 2 8627 4583

Fax

mark.dadds@sydney.edu.au

Contact person for public queries

Name

Meryn Lechowicz

Address

Child Behaviour Research Clinic
Brain and Mind Centre
97 Church Street, Camperdown
Sydney NSW 2050

Country

Australia

Phone

+612 9114 4326

Fax

scbrc@sydney.edu.au

Contact person for scientific queries

Name

Mark Dadds

Address

Griffith Taylor Building (A 19)
School of Psychology
The University of Sydney, NSW 2006

Country

Australia

Phone

+61 2 8627 4583

Fax

mark.dadds@sydney.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Using Time-out for Child Conduct Problems in the Context of Trauma and Adversity: A Nonrandomized Controlled Trial.	2022	https://dx.doi.org/10.1001/jamanetworkopen.2022.29726

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically