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

Primary Purpose

Attention-deficit/Hyperactivity Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
ADHD Toolkit
Waiting List Control group
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention-deficit/Hyperactivity Disorder focused on measuring Attention-deficit/hyperactivity disorder, School, Behavioral Intervention, RCT

Eligibility Criteria

5 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universitair Ziekenhuis LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Toolkit intervention

Waiting List Control Group

Arm Description

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.

Outcomes

Primary Outcome Measures

DBD Rating Scale: ADHD subscale, teacher rated
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), teacher rated.

Secondary Outcome Measures

DBD Rating Scale: ADHD subscale, parent rated
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), parent rated
DBD Rating Scale, oppositional defiant disorder subscale, teacher rated
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), teacher rated
DBD Rating Scale, oppositional defiant disorder subscale, parent rated
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), parent rated
Target Behaviour Improvement Rating Scale, teacher rated
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
TRF = Teacher Report Form (Achenbach, 1991)
CBCL, subscale internalizing problems
CBCL= Child Behavior Checklist (Achenbach, 1991)
IRS, teacher rated
IRS= Impairment Rating Scale (Fabiano et al, 2006), teacher rated
IRS, parent rated
IRS= Impairment Rating Scale (Fabiano et al, 2006), parent rated
Perceived Competence Scale for Children
Perceived Competence Scale for Children (Harter, 1985)
Student-Teacher Relationship Scale
Student-Teacher Relationship Scale (Pianta, 1991)
Teachers Beliefs and Attitudes towards ADHD Scale, teacher rated
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
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
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
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), teacher rated
DBD Rating Scale, conduct disorder subscale, parent rated
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), parent rated

Full Information

First Posted
April 5, 2011
Last Updated
April 6, 2011
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01330849
Brief Title
Toolkit for School Behavior Modification in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Official Title
A Randomized Controlled Trial of a Behavior Modification Toolkit in Primary School Children With ADHD Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-deficit/Hyperactivity Disorder
Keywords
Attention-deficit/hyperactivity disorder, School, Behavioral Intervention, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Toolkit intervention
Arm Type
Experimental
Arm Title
Waiting List Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ADHD Toolkit
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Waiting List Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
DBD Rating Scale: ADHD subscale, teacher rated
Description
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), teacher rated.
Time Frame
Evaluation after using the ADHD Toolkit for a three month period
Secondary Outcome Measure Information:
Title
DBD Rating Scale: ADHD subscale, parent rated
Description
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), parent rated
Time Frame
Evaluation after using the ADHD Toolkit for a three month period
Title
DBD Rating Scale, oppositional defiant disorder subscale, teacher rated
Description
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), teacher rated
Time Frame
Evaluation after using the ADHD Toolkit for a three month period
Title
DBD Rating Scale, oppositional defiant disorder subscale, parent rated
Description
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), parent rated
Time Frame
Evaluation after using the ADHD Toolkit for a three month period
Title
Target Behaviour Improvement Rating Scale, teacher rated
Description
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
Time Frame
Evaluation after using the ADHD Toolkit for a three month period
Title
TRF, subscale internalizing problems
Description
TRF = Teacher Report Form (Achenbach, 1991)
Time Frame
Evaluation after using the ADHD Toolkit for a three month period
Title
CBCL, subscale internalizing problems
Description
CBCL= Child Behavior Checklist (Achenbach, 1991)
Time Frame
Evaluation after using the ADHD Toolkit for a three month period
Title
IRS, teacher rated
Description
IRS= Impairment Rating Scale (Fabiano et al, 2006), teacher rated
Time Frame
Evaluation after using the ADHD Toolkit for a three month period
Title
IRS, parent rated
Description
IRS= Impairment Rating Scale (Fabiano et al, 2006), parent rated
Time Frame
Evaluation after using the ADHD Toolkit for a three month period
Title
Perceived Competence Scale for Children
Description
Perceived Competence Scale for Children (Harter, 1985)
Time Frame
Evaluation after using the ADHD Toolkit for a three month period
Title
Student-Teacher Relationship Scale
Description
Student-Teacher Relationship Scale (Pianta, 1991)
Time Frame
Evaluation after using the ADHD Toolkit for a three month period
Title
Teachers Beliefs and Attitudes towards ADHD Scale, teacher rated
Description
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.
Time Frame
Evaluation after using the ADHD Toolkit for a three month period
Title
Feasibility, Acceptability and Usefulness Scale, teacher rated
Description
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).
Time Frame
Evaluation after using the ADHD Toolkit for a three month period
Title
Feasibility, Acceptability and Usefulness Scale, student rated
Description
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).
Time Frame
Evaluation after using the ADHD Toolkit for a three month period
Title
DBD Rating Scale, conduct disorder subscale, teacher rated
Description
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), teacher rated
Time Frame
Evaluation after using the ADHD Toolkit for a three month period
Title
DBD Rating Scale, conduct disorder subscale, parent rated
Description
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), parent rated
Time Frame
Evaluation after using the ADHD Toolkit for a three month period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Danckaerts
Phone
(+32)16343821
Email
marina.danckaerts@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Danckaerts, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Danckaerts
Phone
(+32)16343821
Email
marina.danckaerts@uzleuven.be

12. IPD Sharing Statement

Learn more about this trial

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

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