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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
  • Universitair Ziekenhuis Leuven

    Leuven, Vlaams-Brabant, 3000

    Marina Danckaerts, (+32)16343821, marina.danckaerts@uzleuven.be

    Recruiting

Other trials in Belgium

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.

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 groups in NCT01330849
Study groupRoleWhat they receive
Toolkit interventionExperimentalNot described
Receives: Behavioral: ADHD Toolkit
Waiting List Control GroupNo interventionChildren 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. TRF, subscale internalizing problems

    TRF = Teacher Report Form (Achenbach, 1991)

    Measured: Evaluation after using the ADHD Toolkit for a three month period

  6. CBCL, subscale internalizing problems

    CBCL= Child Behavior Checklist (Achenbach, 1991)

    Measured: Evaluation after using the ADHD Toolkit for a three month period

  7. 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

  8. 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

  9. Perceived Competence Scale for Children

    Perceived Competence Scale for Children (Harter, 1985)

    Measured: Evaluation after using the ADHD Toolkit for a three month period

  10. Student-Teacher Relationship Scale

    Student-Teacher Relationship Scale (Pianta, 1991)

    Measured: Evaluation after using the ADHD Toolkit for a three month period

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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.

  1. First posted7 Apr 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionJun 2011 (estimated)
  4. Study completionJun 2011 (estimated)

Resources

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)
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

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.

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