Organizational Skills Training for Children With ADHD (OST)

April 7, 2022 updated by: Aida Bikic, Region Syddanmark
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
142

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Søren Dalsgaard, MD, Ph.D.
  • Phone Number: sdalsgaard@econ.au.dk

Study Locations

  • Denmark
      • Aabenraa, Denmark, 6200
        • Recruiting
        • Department of Child and Adolescent Mental Health Services
      • Vejle, Denmark
        • Recruiting
        • Department of Child and Adolescent Mental Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 13 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ADHD diagnosis after clinical interview K-SADS
  2. age between 6-13 years, both inclusive; informed consent.
  3. 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.

Exclusion Criteria:

  1. autism spectrum disorder
  2. serious psychopathology requiring immediate clinical attention (e.g., severe depression or aggressive behavior)
  3. head injury or verified neurological disease
  4. intelligence quotient (IQ <80)
  5. medical condition, requiring primary treatment
  6. no informed consent from custody.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention
The participants in the intervention group will receive treatment as usual + 10 sessions of organizational skills training
Behavioral: Organizational skills training
10 sessions of parent and child training in a group format.
Other: Treatment as usual
Treatment as usual in the outpatient clinic
OTHER: Control
Control participants will receive treatment as usual.
Other: Treatment as usual
Treatment as usual in the outpatient clinic

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Children Organizational Skills Scale (COSS)-parent
Time Frame: after 10 weeks of intervention
organizational skills questionnaire
after 10 weeks of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Children Organizational Skills Scale (COSS)-teacher
Time Frame: after 10 weeks of intervention
organizational skills questionnaire
after 10 weeks of intervention
ADHD-Rating Scale (ADHD-RS) (parent edition)
Time Frame: after 10 weeks of intervention
ADHD symptoms questionnaire
after 10 weeks of intervention
Behavior Rating Inventory of Executive Functions (BRIEF)-parent
Time Frame: after 10 weeks of intervention
executive functions questionnaire
after 10 weeks of intervention
CANTAB Rapid Visual Movement (RVP)
Time Frame: after 10 weeks of intervention
cognitive test
after 10 weeks of intervention
Weis's scale of disability-Parent Report (WFIRS-P)
Time Frame: after 10 weeks of intervention
functional outcome questionnaire
after 10 weeks of intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Behavior Rating Inventory of Executive Functions (BRIEF)-teacher
Time Frame: after 10 weeks of intervention
executive functions questionnaire
after 10 weeks of intervention
CANTAB Stop Signal Task (SST)
Time Frame: after 10 weeks of intervention
cognitive test
after 10 weeks of intervention
CANTAB one touch Stockings of Cambridge (SOC)
Time Frame: after 10 weeks of intervention
cognitive test
after 10 weeks of intervention
CANTAB Working Memory (WM)
Time Frame: after 10 weeks of intervention
cognitive test
after 10 weeks of intervention
Non-serious adverse events
Time Frame: after 10 weeks of intervention
adverse events
after 10 weeks of intervention
Serious adverse events
Time Frame: after 10 weeks of intervention
adverse events
after 10 weeks of intervention
Children Organizational Skills Scale (COSS)-parent
Time Frame: 24 weeks after ended intervention
organizational skills questionnaire
24 weeks after ended intervention
Children Organizational Skills Scale (COSS)-teacher
Time Frame: 24 weeks after ended intervention
organizational skills questionnaire
24 weeks after ended intervention
ADHD-Rating Scale (ADHD-RS) (parent edition)
Time Frame: 24 weeks after ended intervention
ADHD symptoms questionnaire
24 weeks after ended intervention
ADHD-Rating Scale (ADHD-RS) (teacher edition)
Time Frame: 24 weeks after ended intervention
ADHD symptoms questionnaire
24 weeks after ended intervention
Behavior Rating Inventory of Executive Functions (BRIEF)-parent
Time Frame: 24 weeks after ended intervention
executive functions questionnaire
24 weeks after ended intervention
Behavior Rating Inventory of Executive Functions (BRIEF)-teacher
Time Frame: 24 weeks after ended intervention
executive functions questionnaire
24 weeks after ended intervention
CANTAB Stop Signal Task (SST)
Time Frame: 24 weeks after ended intervention
cognitive test
24 weeks after ended intervention
CANTAB one touch Stockings of Cambridge (SOC)
Time Frame: 24 weeks after ended intervention
cognitive test
24 weeks after ended intervention
CANTAB Rapid Visual Movement (RVP)
Time Frame: 24 weeks after ended intervention
cognitive test
24 weeks after ended intervention
CANTAB Working Memory (WM)
Time Frame: 24 weeks after ended intervention
cognitive test
24 weeks after ended intervention
Weis's scale of disability-Parent Report (WFIRS-P)
Time Frame: 24 weeks after ended intervention
functional outcome questionnaire
24 weeks after ended intervention
Non-serious adverse events
Time Frame: 24 weeks after ended intervention
adverse events
24 weeks after ended intervention
Serious adverse events
Time Frame: 24 weeks after ended intervention
adverse events
24 weeks after ended intervention
CANTAB Reaction time task (RTI)
Time Frame: after 10 weeks of intervention
reaction time
after 10 weeks of intervention
CANTAB Reaction time task (RTI)
Time Frame: after 24 weeks of intervention
reaction time
after 24 weeks of intervention
ADHD-Rating Scale (ADHD-RS) (teacher edition)
Time Frame: after 10 weeks of intervention
ADHD symptoms questionnaire
after 10 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Syddanmark

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aida Bikic, Ph.D., Region of Southern Denmark and University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 55772 S-20160180

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

After the competition of the study, data will be stored in Danish National Archives, where data can be accessed after previous approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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