Attention-deficit/Hyperactivity Disorder Clinical Trial
Official title:
A Randomized Controlled Trial of a Behavior Modification Toolkit in Primary School Children With ADHD Behaviors
The purpose of this study is to examine the efficacy of the ADHD-Toolkit (a toolkit for school behaviour modification in primary school children with ADHD-behaviours) in terms of general improvement in ADHD symptoms, specific targeted school-related problem behaviours, other disruptive behaviour disorder symptoms, teacher attitudes towards ADHD, teacher-child relationship and child self-esteem.
Attention-Deficit/Hyperactivity Disorder (ADHD) is a debilitating and common disorder of
childhood marked by pervasive and persistent patterns of inattention, overactivity and
impulsiveness. It is associated with impairment in a range of domains at both home and
school and leads to long term educational and vocational underachievement, delinquency and
conduct disorder and social and marital problems. Current treatment approaches involve both
pharmacological and non-pharmacological options. Non-pharmacological options tend to focus
on home-based approaches such as parent training. These can be effective especially in
limiting impairment and reducing symptoms of comorbid problems such as oppositional defiant
disorder (ODD) and other psychiatric comorbidities. This can really improve the quality of
life of children with ADHD. However, a major problem with these home-based approaches is
that their effects are unlikely to generalise to the school setting. This means that to
effectively treat ADHD and to deal with impairment at both home and at school one needs to
supplement home based approaches with effective school based strategies.
Classroom-based approaches that have been tried with ADHD can be divided into two types
(Pelham & Fabiano, 2008). First, there are classroom based management strategies where
teachers manipulate the consequences of behaviour to reduce (i.e., negatively reinforce)
inappropriate behaviours (aggression, loss of concentration, disruptiveness) and increase
(reinforce) appropriate behaviours (compliance, concentration). The second type of
intervention focuses on academic targets through manipulating the academic instruction and
materials (i.e., reducing task length, peer tutoring). In the current proposal the
investigators focus on the first category. Pelham & Fabiano (2008) recently concluded that
"the evidence for BCM [behavioural classroom management] for ADHD was substantial".
However, while there is a considerable evidence base for the value of classroom management
as a component of ADHD treatment in multi-modal psychosocial treatment packages in
school-aged children, there is a lack of well designed randomized studies in a naturalistic
school setting that can provide a definitive estimate of efficacy for such approaches.
At the University Hospital of Leuven a toolkit for school behaviour modification in children
with ADHD has been developed and piloted. This is an instrument for teachers to
systematically target specific behaviours in the classroom and the playground with the
ultimate goal of improving school ADHD behaviours and reducing oppositionality. Teachers
will identify the behaviours which are most challenging and apply a series of levels of
intervention with increasing intensity of monitoring, feedback and training. The effect of a
three month application of the toolkit will be evaluated compared to a waiting list control
group. Outcome measures will include measures of ADHD behaviours, oppositional defiant
behaviour, teacher attitudes towards ADHD, teacher-child relationship and child self-esteem.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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