Organizational Skills Training for Children With ADHD

ADHD Clinical Trial

— OST  

Official title:

Organizational Skills Training for Children With ADHD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03160378
• Other study ID #: 55772 S-20160180
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2017
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2022
• Source: Region Syddanmark
• Contact: Aida Bikic, Ph.D.
• Phone: +45 29168216
• Email: aida.bikic[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Half of the participants will receive treatment as usual (TAU) and organizational skills training and the other half will receive TAU.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Child and Adolescent Mental Health Services	Aabenraa
Denmark	Department of Child and Adolescent Mental Health Services	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Region Syddanmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Behavior Rating Inventory of Executive Functions (BRIEF)-teacher	executive functions questionnaire	after 10 weeks of intervention
Other	CANTAB Stop Signal Task (SST)	cognitive test	after 10 weeks of intervention
Other	CANTAB one touch Stockings of Cambridge (SOC)	cognitive test	after 10 weeks of intervention
Other	CANTAB Working Memory (WM)	cognitive test	after 10 weeks of intervention
Other	Non-serious adverse events	adverse events	after 10 weeks of intervention
Other	Serious adverse events	adverse events	after 10 weeks of intervention
Other	Children Organizational Skills Scale (COSS)-parent	organizational skills questionnaire	24 weeks after ended intervention
Other	Children Organizational Skills Scale (COSS)-teacher	organizational skills questionnaire	24 weeks after ended intervention
Other	ADHD-Rating Scale (ADHD-RS) (parent edition)	ADHD symptoms questionnaire	24 weeks after ended intervention
Other	ADHD-Rating Scale (ADHD-RS) (teacher edition)	ADHD symptoms questionnaire	24 weeks after ended intervention
Other	Behavior Rating Inventory of Executive Functions (BRIEF)-parent	executive functions questionnaire	24 weeks after ended intervention
Other	Behavior Rating Inventory of Executive Functions (BRIEF)-teacher	executive functions questionnaire	24 weeks after ended intervention
Other	CANTAB Stop Signal Task (SST)	cognitive test	24 weeks after ended intervention
Other	CANTAB one touch Stockings of Cambridge (SOC)	cognitive test	24 weeks after ended intervention
Other	CANTAB Rapid Visual Movement (RVP)	cognitive test	24 weeks after ended intervention
Other	CANTAB Working Memory (WM)	cognitive test	24 weeks after ended intervention
Other	Weis's scale of disability-Parent Report (WFIRS-P)	functional outcome questionnaire	24 weeks after ended intervention
Other	Non-serious adverse events	adverse events	24 weeks after ended intervention
Other	Serious adverse events	adverse events	24 weeks after ended intervention
Other	CANTAB Reaction time task (RTI)	reaction time	after 10 weeks of intervention
Other	CANTAB Reaction time task (RTI)	reaction time	after 24 weeks of intervention
Other	ADHD-Rating Scale (ADHD-RS) (teacher edition)	ADHD symptoms questionnaire	after 10 weeks of intervention
Primary	Children Organizational Skills Scale (COSS)-parent	organizational skills questionnaire	after 10 weeks of intervention
Secondary	Children Organizational Skills Scale (COSS)-teacher	organizational skills questionnaire	after 10 weeks of intervention
Secondary	ADHD-Rating Scale (ADHD-RS) (parent edition)	ADHD symptoms questionnaire	after 10 weeks of intervention
Secondary	Behavior Rating Inventory of Executive Functions (BRIEF)-parent	executive functions questionnaire	after 10 weeks of intervention
Secondary	CANTAB Rapid Visual Movement (RVP)	cognitive test	after 10 weeks of intervention
Secondary	Weis's scale of disability-Parent Report (WFIRS-P)	functional outcome questionnaire	after 10 weeks of intervention