Toolkit for School Behavior Modification in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01330849
First received: April 5, 2011
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Attention-deficit/Hyperactivity Disorder
Behavioral: ADHD Toolkit
Other: Waiting List Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of a Behavior Modification Toolkit in Primary School Children With ADHD Behaviors

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • DBD Rating Scale: ADHD subscale, teacher rated [ Time Frame: Evaluation after using the ADHD Toolkit for a three month period ] [ Designated as safety issue: No ]
    DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), teacher rated.


Secondary Outcome Measures:
  • DBD Rating Scale: ADHD subscale, parent rated [ Time Frame: Evaluation after using the ADHD Toolkit for a three month period ] [ Designated as safety issue: No ]
    DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), parent rated

  • DBD Rating Scale, oppositional defiant disorder subscale, teacher rated [ Time Frame: Evaluation after using the ADHD Toolkit for a three month period ] [ Designated as safety issue: No ]
    DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), teacher rated

  • DBD Rating Scale, oppositional defiant disorder subscale, parent rated [ Time Frame: Evaluation after using the ADHD Toolkit for a three month period ] [ Designated as safety issue: No ]
    DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), parent rated

  • Target Behaviour Improvement Rating Scale, teacher rated [ Time Frame: Evaluation after using the ADHD Toolkit for a three month period ] [ Designated as safety issue: No ]
    Target Behaviour Improvement Rating Scale = a 24-item questionnaire (unpublished) based on the 24 target school behaviours listed in the treatment manual of the ADHD Toolkit (URL: http://www.uzleuven.be/adhd-toolkit), each item is scored on a four-point Likert scale, teacher rated

  • TRF, subscale internalizing problems [ Time Frame: Evaluation after using the ADHD Toolkit for a three month period ] [ Designated as safety issue: No ]
    TRF = Teacher Report Form (Achenbach, 1991)

  • CBCL, subscale internalizing problems [ Time Frame: Evaluation after using the ADHD Toolkit for a three month period ] [ Designated as safety issue: No ]
    CBCL= Child Behavior Checklist (Achenbach, 1991)

  • IRS, teacher rated [ Time Frame: Evaluation after using the ADHD Toolkit for a three month period ] [ Designated as safety issue: No ]
    IRS= Impairment Rating Scale (Fabiano et al, 2006), teacher rated

  • IRS, parent rated [ Time Frame: Evaluation after using the ADHD Toolkit for a three month period ] [ Designated as safety issue: No ]
    IRS= Impairment Rating Scale (Fabiano et al, 2006), parent rated

  • Perceived Competence Scale for Children [ Time Frame: Evaluation after using the ADHD Toolkit for a three month period ] [ Designated as safety issue: No ]
    Perceived Competence Scale for Children (Harter, 1985)

  • Student-Teacher Relationship Scale [ Time Frame: Evaluation after using the ADHD Toolkit for a three month period ] [ Designated as safety issue: No ]
    Student-Teacher Relationship Scale (Pianta, 1991)

  • Teachers Beliefs and Attitudes towards ADHD Scale, teacher rated [ Time Frame: Evaluation after using the ADHD Toolkit for a three month period ] [ Designated as safety issue: No ]
    Teachers Beliefs and Attitudes towards ADHD Scale = A 20-item questionnaire (unpublished) looking at attributions of cause of ADHD, characteristics of children with ADHD and treatment options for ADHD. This questionnaire is a modification of Charlotte Johnstons ADHD Beliefs and Attitudes Scale [Johnston, C.(2001). ADHD Beliefs and Attitudes Scale. Unpublished scale.]. Scoring on a seven-point Likert scale, teacher rated.

  • Feasibility, Acceptability and Usefulness Scale, teacher rated [ Time Frame: Evaluation after using the ADHD Toolkit for a three month period ] [ Designated as safety issue: No ]
    Feasibility, Acceptability and Usefulness Scale = A 15-item questionnaire measuring the feasibility, acceptability and usefulness of the ADHD Toolkit intervention, scoring on a five-point Likert scale, teacher rated. This questionnaire was developed specifically for this study (unpublished).

  • Feasibility, Acceptability and Usefulness Scale, student rated [ Time Frame: Evaluation after using the ADHD Toolkit for a three month period ] [ Designated as safety issue: No ]
    Feasibility, Acceptability and Usefulness Scale = An 11-item questionnaire measuring the feasibility, acceptability and usefulness of the ADHD Toolkit intervention, scoring on a five-point Likert scale, student rated. This questionnaire was developed specifically for this study (unpublished).

  • DBD Rating Scale, conduct disorder subscale, teacher rated [ Time Frame: Evaluation after using the ADHD Toolkit for a three month period ] [ Designated as safety issue: No ]
    DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), teacher rated

  • DBD Rating Scale, conduct disorder subscale, parent rated [ Time Frame: Evaluation after using the ADHD Toolkit for a three month period ] [ Designated as safety issue: No ]
    DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), parent rated


Estimated Enrollment: 100
Study Start Date: December 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Toolkit intervention Behavioral: ADHD Toolkit
For children allocated to the active intervention arm, teachers are trained to apply the ADHD Toolkit. Teacher will use the behaviour modification tool for 3 months. They are trained to select target behaviours causing impairment for the child and will apply a systematic approach of increased intensity of monitoring and feedback for the behaviour, including training of appropriate behaviour.
No Intervention: Waiting List Control Group
Children eligible for the study according to the inclusion criteria, but randomly allocated to the waiting list control group are promised to receive the intervention AFTER the study is finished.
Other: Waiting List Control group
Children in the control group will receive no specific intervention, but are promised that their teachers will apply the schoolkit for them after the study.

Detailed 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.

  Eligibility

Ages Eligible for Study:   5 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The teacher must rate the ADHD symptoms of the student above or equal to the 90,9th percentile on the inattention or hyperactivity/impulsivity subscale of the VvGK (a Dutch translation of the Disruptive Behaviour Disorders Rating Scale).
  • There is a maximum of 2 children per classroom that may be included.

Exclusion Criteria:

  • None (Medication use would not be a reason for exclusion from the sample if children still fulfill the inclusion criteria)(Children with mental retardation (IQ < 70) will automatically be excluded from the study, since the study runs in normal schools.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330849

Contacts
Contact: Marina Danckaerts (+32)16343821 marina.danckaerts@uzleuven.be

Locations
Belgium
Universitair Ziekenhuis Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Marina Danckaerts    (+32)16343821    marina.danckaerts@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Marina Danckaerts, PhD Universitaire Ziekenhuizen Leuven
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. dr. Marina Danckaerts, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01330849     History of Changes
Other Study ID Numbers: S52891
Study First Received: April 5, 2011
Last Updated: April 6, 2011
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
Attention-deficit/hyperactivity disorder
School
Behavioral Intervention
RCT

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 25, 2014