Attention-deficit/Hyperactivity DisorderNCT01330849
Toolkit for School Behavior Modification in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
A study testing ADHD Toolkit in people with Attention-deficit/Hyperactivity Disorder, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention-deficit/Hyperactivity Disorder
- What is being tested?
- ADHD Toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Leuven
Leuven, Vlaams-Brabant, 3000
Marina Danckaerts, (+32)16343821, marina.danckaerts@uzleuven.be
About this study
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.
Read the 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.
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Being tested
- ADHD Toolkit, Waiting List Control group
- Keywords
- Attention-deficit/hyperactivity disorder, School, Behavioral Intervention, RCT
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADHD ToolkitBehavioural
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.
Waiting List Control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Toolkit intervention | Experimental | Not described Receives: Behavioral: ADHD Toolkit |
| Waiting List Control Group | No intervention | 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. Receives: Other: Waiting List Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
DBD Rating Scale: ADHD subscale, teacher rated
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), teacher rated.
Measured: Evaluation after using the ADHD Toolkit for a three month period
Secondary outcomes (15)
DBD Rating Scale: ADHD subscale, parent rated
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), parent rated
Measured: Evaluation after using the ADHD Toolkit for a three month period
DBD Rating Scale, oppositional defiant disorder subscale, teacher rated
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), teacher rated
Measured: Evaluation after using the ADHD Toolkit for a three month period
DBD Rating Scale, oppositional defiant disorder subscale, parent rated
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), parent rated
Measured: Evaluation after using the ADHD Toolkit for a three month period
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
Measured: Evaluation after using the ADHD Toolkit for a three month period
TRF, subscale internalizing problems
TRF = Teacher Report Form (Achenbach, 1991)
Measured: Evaluation after using the ADHD Toolkit for a three month period
CBCL, subscale internalizing problems
CBCL= Child Behavior Checklist (Achenbach, 1991)
Measured: Evaluation after using the ADHD Toolkit for a three month period
IRS, teacher rated
IRS= Impairment Rating Scale (Fabiano et al, 2006), teacher rated
Measured: Evaluation after using the ADHD Toolkit for a three month period
IRS, parent rated
IRS= Impairment Rating Scale (Fabiano et al, 2006), parent rated
Measured: Evaluation after using the ADHD Toolkit for a three month period
Perceived Competence Scale for Children
Perceived Competence Scale for Children (Harter, 1985)
Measured: Evaluation after using the ADHD Toolkit for a three month period
Student-Teacher Relationship Scale
Student-Teacher Relationship Scale (Pianta, 1991)
Measured: Evaluation after using the ADHD Toolkit for a three month period
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.
Measured: Evaluation after using the ADHD Toolkit for a three month period
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).
Measured: Evaluation after using the ADHD Toolkit for a three month period
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).
Measured: Evaluation after using the ADHD Toolkit for a three month period
DBD Rating Scale, conduct disorder subscale, teacher rated
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), teacher rated
Measured: Evaluation after using the ADHD Toolkit for a three month period
DBD Rating Scale, conduct disorder subscale, parent rated
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), parent rated
Measured: Evaluation after using the ADHD Toolkit for a three month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startDec 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Investigators
- Marina Danckaerts, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330849
- Sponsor's protocol ID
- S52891
- Status last verified
- Apr 2011
- First submitted
- 5 Apr 2011
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Behavior Modification Toolkit in Primary School Children With ADHD Behaviors
- ClinicalTrials.gov ID
- NCT01330849
- Acronym / sponsor ID
- S52891
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Keywords
- Attention-deficit/hyperactivity disorder, School, Behavioral Intervention, RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 7 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toolkit intervention | Experimental | Behavioral: ADHD Toolkit |
| Waiting List Control Group | No intervention | Other: Waiting List Control groupChildren 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. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADHD ToolkitFor 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. | Behavioural | Toolkit intervention |
| Waiting List Control groupChildren in the control group will receive no specific intervention, but are promised that their teachers will apply the schoolkit for them after the study. | Other | Waiting List Control Group |
Primary outcome
DBD Rating Scale: ADHD subscale, teacher rated
Time frame: Evaluation after using the ADHD Toolkit for a three month period
DBD = Disruptive Behaviour Disorder Rating Scale (Pelham et al, 1992), teacher rated.
15 secondary outcomes
DBD Rating Scale: ADHD subscale, parent rated
Time frame: Evaluation after using the ADHD Toolkit for a three month period
DBD Rating Scale, oppositional defiant disorder subscale, teacher rated
Time frame: Evaluation after using the ADHD Toolkit for a three month period
DBD Rating Scale, oppositional defiant disorder subscale, parent rated
Time frame: Evaluation after using the ADHD Toolkit for a three month period
Target Behaviour Improvement Rating Scale, teacher rated
Time frame: Evaluation after using the ADHD Toolkit for a three month period
TRF, subscale internalizing problems
Time frame: Evaluation after using the ADHD Toolkit for a three month period
CBCL, subscale internalizing problems
Time frame: Evaluation after using the ADHD Toolkit for a three month period
IRS, teacher rated
Time frame: Evaluation after using the ADHD Toolkit for a three month period
IRS, parent rated
Time frame: Evaluation after using the ADHD Toolkit for a three month period
Perceived Competence Scale for Children
Time frame: Evaluation after using the ADHD Toolkit for a three month period
Student-Teacher Relationship Scale
Time frame: Evaluation after using the ADHD Toolkit for a three month period
Teachers Beliefs and Attitudes towards ADHD Scale, teacher rated
Time frame: Evaluation after using the ADHD Toolkit for a three month period
Feasibility, Acceptability and Usefulness Scale, teacher rated
Time frame: Evaluation after using the ADHD Toolkit for a three month period
Feasibility, Acceptability and Usefulness Scale, student rated
Time frame: Evaluation after using the ADHD Toolkit for a three month period
DBD Rating Scale, conduct disorder subscale, teacher rated
Time frame: Evaluation after using the ADHD Toolkit for a three month period
DBD Rating Scale, conduct disorder subscale, parent rated
Time frame: Evaluation after using the ADHD Toolkit for a three month period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Danckaerts, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADHD Toolkit in people with Attention-deficit/Hyperactivity Disorder, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Danckaerts ((+32)16343821, marina.danckaerts@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DBD Rating Scale: ADHD subscale, teacher rated (time frame: Evaluation after using the ADHD Toolkit for a three month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2011.