Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention-deficit/Hyperactivity Disorder
  • Hyperkinesis

NCT number NCT01330849
Study type Interventional
Source Universitaire Ziekenhuizen Leuven
Contact Marina Danckaerts
Phone (+32)16343821
Email marina.danckaerts@uzleuven.be
Status Recruiting
Phase N/A
Start date December 2010
Completion date June 2011

See also
  Status Clinical Trial Phase
Completed NCT02251743 - Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD N/A
Completed NCT02226445 - Treatment Drop-out and Missed Appointments Among Adults With ADHD N/A
Completed NCT01342445 - Effects of LDX on Functioning of College Students With ADHD Phase 4
Not yet recruiting NCT00391495 - Inflammation in Children With Attention-Deficit/Hyperactivity Disorder N/A
Completed NCT00528697 - A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) Phase 2
Completed NCT00494819 - Validity of ADHD Subtypes Using Neuropsychological Measure N/A
Completed NCT02217371 - Role of Circadian and Homeostatic Systems in the Regulation of Wakefulness in Adult Patients With Attention Deficit Disorder With or Without Hyperactivity N/A
Completed NCT01081132 - Dose-optimization in Adolescents Aged 13-17 Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD) Using Extended-release Guanfacine HCl Phase 3
Completed NCT06064942 - Multiple Family Narrative Therapy for Chinese Families of Children With Attention Deficit Hyperactivity Disorder N/A
Completed NCT00391729 - A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) Phase 2
Completed NCT00191048 - Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHD Phase 4
Terminated NCT00554385 - A Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) Phase 2
Completed NCT00997984 - Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study) Phase 3
Not yet recruiting NCT05568446 - Social VR Based Intervention on Enhancing Social Interaction Skills in Children With AD/HD N/A
Completed NCT02096952 - Methylphenidate ER Liquid Formulation in Adults With ASD and ADHD Phase 4
Recruiting NCT02623114 - Attention-deficit/Hyperactivity Disorder Translational Center for Identifying Biomarkers Phase 4
Completed NCT01351246 - Guided Self-Help for Parents of Children With Attention-Deficit/Hyperactivity Disorder (ADHD) N/A
Completed NCT00686933 - Long Term Safety and Tolerability Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) Phase 2
Completed NCT00491647 - Time Perception Deficits and Attention-Deficit/Hyperactivity Disorder N/A
Completed NCT01081145 - Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD) Phase 3