RecruitingACTRN12617001472369

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.

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.


Sponsor

Professor Mark Dadds

Enrollment

400 participants

Start Date

Oct 23, 2017

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 2 YearssMax Age: 8 Yearss

Plain Language Summary

Simplified for easier understanding

This study looks at how a parenting program affects children aged 2 to 8 years who have behaviour problems like oppositional defiant disorder or conduct disorder. Researchers want to understand how parenting interventions improve children's behaviour and how they may even influence changes in the child's genes that are related to brain development. You may be eligible if: - Your child is between 2 and 8 years old - Your child has been assessed as having conduct problems (such as oppositional defiant disorder or conduct disorder) - Your family is fluent in English - Your child may also have ADHD, anxiety, or mild learning difficulties — these do not automatically exclude participation You may NOT be eligible if: - Your child has a current psychotic disorder - Your child has moderate or severe autism spectrum disorder - Your child has an intellectual disability (estimated IQ below 70) - Your child has a major medical condition that seriously affects family or school life - Your family is involved in active legal issues including child custody disputes Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 o

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)


Locations(1)

NSW, Australia

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ACTRN12617001472369