NCT01330849

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 7, 2011

Status Verified

April 1, 2011

Enrollment Period

6 months

First QC Date

April 5, 2011

Last Update Submit

April 6, 2011

Conditions

Attention-deficit/Hyperactivity Disorder

Keywords

Attention-deficit/hyperactivity disorderSchoolBehavioral InterventionRCT

Outcome Measures

Primary Outcomes (1)

  • DBD Rating Scale: ADHD subscale, teacher rated

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

    Evaluation after using the ADHD Toolkit for a three month period

Secondary Outcomes (15)

  • DBD Rating Scale: ADHD subscale, parent rated

    Evaluation after using the ADHD Toolkit for a three month period

  • DBD Rating Scale, oppositional defiant disorder subscale, teacher rated

    Evaluation after using the ADHD Toolkit for a three month period

  • DBD Rating Scale, oppositional defiant disorder subscale, parent rated

    Evaluation after using the ADHD Toolkit for a three month period

  • Target Behaviour Improvement Rating Scale, teacher rated

    Evaluation after using the ADHD Toolkit for a three month period

  • TRF, subscale internalizing problems

    Evaluation after using the ADHD Toolkit for a three month period

  • +10 more secondary outcomes

Study Arms (2)

Toolkit intervention

EXPERIMENTAL
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.

Other: Waiting List Control group

Interventions

ADHD ToolkitBEHAVIORAL

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.

Toolkit intervention
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.

Waiting List Control Group

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Marina Danckaerts, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Danckaerts

CONTACT

(+32)16343821marina.danckaerts@uzleuven.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 5, 2011

First Posted

April 7, 2011

Study Start

December 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

April 7, 2011

Record last verified: 2011-04

Locations

BE(1)