Attention Deficit Hyperactivity Disorder Clinical Trial
Official title:
Parent Training for Preschool ADHD: A Randomised Controlled, Multicentre Effectiveness Trial of the New Forest Parenting Programme in a Clinical Sample of Danish Children
The purpose of this study is to investigate the effectiveness of parent training in the treatment of ADHD in young children (ages 3-7) referred to Danish child mental health services. Medication is not recommended as first-line treatment for young children with ADHD. Parent training is recommended, but has not been formally introduced or established in Denmark. The study will investigate the effectiveness of a parent training programme specifically developed to target ADHD symptoms in young children; The New Forest Parenting Programme, against Treatment as Usual for children diagnosed with ADHD at two different child mental health clinics in Denmark.
Description: A study to: 1) Address the need for non-pharmacological treatment in young
children with ADHD and 2) Address the need for the development of evidence-based psychosocial
treatment interventions in Danish child mental health services, through the implementation of
the New Forest Parenting Programme (NFPP).
Rationale: ADHD is a neuro-developmental disorder with symptoms frequently occurring in early
childhood. ADHD is associated with long-term personal, psychosocial sequalae. ADHD presents a
considerable societal cost burden, both for mental health services, but also in areas such as
education, employment, the criminal justice system. Pharmacological treatment of preschool
ADHD is not recommended as first-line treatment, due to a number of reasons, including lack
of evidence for efficacy, parental concerns, side effects on growth rates, and the unknown
long-term implications for the developing brain. Effective psychosocial treatments for ADHD
are therefore of central public priority generally, and for child mental health services,
specifically. Currently, psychosocial interventions for ADHD in pre-school children in Danish
Child and Adolescent Mental Health Services (CAMHS) are not well described or systematically
developed. There is a pressing need to develop evidence-based psycho-social treatments for
young children with ADHD in Danish CAMHS.
Design: The study will be a randomised controlled multi-centre effectiveness trial comparing
NFPP intervention to a Treatment as Usual control group. The trial will recruit 200 preschool
children (aged 3-6) with a diagnosis of ADHD from two Danish outpatient child mental health
service sites. Participants will be randomised to either 1) NFPP over a period of 8 weeks or
2) a control group receiving Treatment as Usual (TAU). Outcome: The primary outcome measure
will be child ADHD symptoms. Secondary outcomes include parental wellbeing, child quality of
life, parent-child interactions. Measures will be collected at three time points to track
changes in outcome: T1: Before start of intervention or TAU condition. T2: Directly after the
intervention or TAU and T3: 6 month follow-up after T1 for both arms of the trial. The study
will perform exploratory moderator and mediator analyses.
Expertise: The study receives external consultation from an international expert team for the
planning, execution, NFPP training and supervision. The team consists of research and
clinical experts in the treatment and evaluation of interventions for preschool ADHD.
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