ADHDOSTNCT03160378
Organizational Skills Training for Children With ADHD
A study testing Organizational skills training and Treatment as usual in people with ADHD, run by Region Syddanmark at 2 sites in Denmark.
Trial summary
The purpose of this trial is to investigate the effect of organizational skills training, a parent and child training approach on organizational skills, inattentive symptoms and functional outcome in children age 6-13 years. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- ADHD
- What is being tested?
- Organizational skills training and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 2 sitesDenmark
- Study dates
- 22 May 2017to 1 Dec 2022
- 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 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ADHD diagnosis after clinical interview K-SADS
- age between 6-13 years, both inclusive; informed consent.
- The child has to score at least one standard deviation (SD) above the mean on the Plan/Organize subscale on the Behavior Rating Inventory of Executive Functions (BRIEF) (parent edition) verifying problems with organizational skills.
Who cannot join
- autism spectrum disorder
- serious psychopathology requiring immediate clinical attention (e.g., severe depression or aggressive behavior)
- head injury or verified neurological disease
- intelligence quotient (IQ <80)
- medical condition, requiring primary treatment
- no informed consent from custody.
Trial locations and contacts
2 sites in 1 country.
Søren Dalsgaard, MD, Ph.D. contact
Denmark2 sites, 2 recruiting
- Recruiting
Department of Child and Adolescent Mental Health Services
Aabenraa, 6200
Aida Bikic, Ph.D.
aida.bikic@rsyd.dk
- Recruiting
Department of Child and Adolescent Mental Health Services
Vejle
Aida Bikic, Ph.D.
aida.bikic@rsyd.dk
About this study
The purpose of this trial is to investigate the effect of organizational skills training, a parent and child training approach on organizational skills, inattentive symptoms and functional outcome in children age 6-13 years. Half of the participants will receive treatment as usual (TAU) and organizational skills training and the other half will receive TAU.
Read the detailed description
Organizational skills training (OST) is a behavioral intervention that has been increasingly used to address difficulties with time management and organization of materials in children with ADHD, that tend to persist despite medication and behavioral treatments. This randomized clinical superiority trial is going to investigate the effect of Organizational Skills Training, a group treatment approach for parents and children. The program is also involving a computerized program, vTime, that will help the children manage time more effectively. A total of 98 children with ADHD aged 6-13 years is expected to be randomized to either intervention or control group in a single blind design. Both groups will receive treatment-as-usual. The intervention group is going to participate in a group training for parents and children for 10 weekly sessions.
- Conditions
- ADHD
- Being tested
- Organizational skills training, Treatment as usual
- 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.
Organizational skills trainingBehavioural
10 sessions of parent and child training in a group format.
Treatment as usualOther
Treatment as usual in the outpatient clinic
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The participants in the intervention group will receive treatment as usual + 10 sessions of organizational skills training Receives: Behavioral: Organizational skills training; Other: Treatment as usual |
| Control | Other | Control participants will receive treatment as usual. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children Organizational Skills Scale (COSS)-parent
organizational skills questionnaire
Measured: after 10 weeks of intervention
Secondary outcomes (5)
Children Organizational Skills Scale (COSS)-teacher
organizational skills questionnaire
Measured: after 10 weeks of intervention
ADHD-Rating Scale (ADHD-RS) (parent edition)
ADHD symptoms questionnaire
Measured: after 10 weeks of intervention
Behavior Rating Inventory of Executive Functions (BRIEF)-parent
executive functions questionnaire
Measured: after 10 weeks of intervention
CANTAB Rapid Visual Movement (RVP)
cognitive test
Measured: after 10 weeks of intervention
Weis's scale of disability-Parent Report (WFIRS-P)
functional outcome questionnaire
Measured: after 10 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start22 May 2017
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Syddanmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Bikic, Region Syddanmark
- Investigators
- Aida Bikic, Ph.D., Principal investigator, Region of Southern Denmark and University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160378
- Sponsor's protocol ID
- 55772 S-20160180
- Acronym
- OST
- Status last verified
- Apr 2022
- First submitted
- 16 May 2017
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After the competition of the study, data will be stored in Danish National Archives, where data can be accessed after previous approval.
Publications
Bikic A, Dalsgaard S, Olsen KD, Sukhodolsky DG. Organizational skills training for children with ADHD: study protocol for a randomized, controlled trial. Trials. 2021 Oct 29;22(1):752. doi: 10.1186/s13063-021-05499-9.
PubMed 34715906
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organizational Skills Training for Children With ADHD
- ClinicalTrials.gov ID
- NCT03160378
- Acronym / sponsor ID
- OST / 55772 S-20160180
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Region SyddanmarkUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 19 May 2017 (actual)
- 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 trial is to investigate the effect of organizational skills training, a parent and child training approach on organizational skills, inattentive symptoms and functional outcome in children age 6-13 years. Half of the participants will receive treatment as usual (TAU) and organizational skills training and the other half will receive TAU.
Detailed description
Organizational skills training (OST) is a behavioral intervention that has been increasingly used to address difficulties with time management and organization of materials in children with ADHD, that tend to persist despite medication and behavioral treatments. This randomized clinical superiority trial is going to investigate the effect of Organizational Skills Training, a group treatment approach for parents and children. The program is also involving a computerized program, vTime, that will help the children manage time more effectively. A total of 98 children with ADHD aged 6-13 years is expected to be randomized to either intervention or control group in a single blind design. Both groups will receive treatment-as-usual. The intervention group is going to participate in a group training for parents and children for 10 weekly sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Organizational skills training, Other: Treatment as usualThe participants in the intervention group will receive treatment as usual + 10 sessions of organizational skills training |
| Control | Other | Other: Treatment as usualControl participants will receive treatment as usual. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ADHD diagnosis after clinical interview K-SADS
- age between 6-13 years, both inclusive; informed consent.
- The child has to score at least one standard deviation (SD) above the mean on the Plan/Organize subscale on the Behavior Rating Inventory of Executive Functions (BRIEF) (parent edition) verifying problems with organizational skills.
Key exclusion criteria (6 listed)
- autism spectrum disorder
- serious psychopathology requiring immediate clinical attention (e.g., severe depression or aggressive behavior)
- head injury or verified neurological disease
- intelligence quotient (IQ <80)
- medical condition, requiring primary treatment
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 |
|---|---|---|
| Organizational skills training10 sessions of parent and child training in a group format. | Behavioural | Intervention |
| Treatment as usualTreatment as usual in the outpatient clinic | Other | Control, Intervention |
Primary outcome
Children Organizational Skills Scale (COSS)-parent
Time frame: after 10 weeks of intervention
organizational skills questionnaire
5 secondary outcomes
Children Organizational Skills Scale (COSS)-teacher
Time frame: after 10 weeks of intervention
ADHD-Rating Scale (ADHD-RS) (parent edition)
Time frame: after 10 weeks of intervention
Behavior Rating Inventory of Executive Functions (BRIEF)-parent
Time frame: after 10 weeks of intervention
CANTAB Rapid Visual Movement (RVP)
Time frame: after 10 weeks of intervention
Weis's scale of disability-Parent Report (WFIRS-P)
Time frame: after 10 weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Derived from this study: PubMed 34715906Bikic A, Dalsgaard S, Olsen KD, Sukhodolsky DG. Organizational skills training for children with ADHD: study protocol for a randomized, controlled trial. Trials. 2021 Oct 29;22(1):752. doi: 10.1186/s13063-021-05499-9.
- Individual participant dataSharing planned: Undecided. After the competition of the study, data will be stored in Danish National Archives, where data can be accessed after previous approval.
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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.
Søren Dalsgaard, MD, Ph.D. contact
Aida Bikic, Ph.D. principal investigator
Region of Southern Denmark and University of Southern Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Organizational skills training and Treatment as usual in people with ADHD, run by Region Syddanmark at 2 sites in Denmark.
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 3 inclusion and 6 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 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 Aida Bikic, Ph.D. (+45 29168216, aida.bikic@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children Organizational Skills Scale (COSS)-parent (time frame: after 10 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03160378, which also lists 1 linked publication.
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 8 Apr 2022.