Clinical trial NCT03160378: Organizational Skills Training for Children With ADHD
Official title: Organizational Skills Training for Children With ADHD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ADHD
Lead sponsor: Region Syddanmark
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 142
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Children Organizational Skills Scale (COSS)-parent
timeFrame: after 10 weeks of intervention
Secondary outcomes:
measure: Children Organizational Skills Scale (COSS)-teacher
timeFrame: after 10 weeks of intervention
measure: ADHD-Rating Scale (ADHD-RS) (parent edition)
timeFrame: after 10 weeks of intervention
measure: Behavior Rating Inventory of Executive Functions (BRIEF)-parent
timeFrame: after 10 weeks of intervention
measure: CANTAB Rapid Visual Movement (RVP)
timeFrame: after 10 weeks of intervention
measure: Weis's scale of disability-Parent Report (WFIRS-P)
timeFrame: after 10 weeks of intervention
Other outcomes:
measure: Behavior Rating Inventory of Executive Functions (BRIEF)-teacher
timeFrame: after 10 weeks of intervention
measure: CANTAB Stop Signal Task (SST)
timeFrame: after 10 weeks of intervention
measure: CANTAB one touch Stockings of Cambridge (SOC)
timeFrame: after 10 weeks of intervention
measure: CANTAB Working Memory (WM)
timeFrame: after 10 weeks of intervention
measure: Non-serious adverse events
timeFrame: after 10 weeks of intervention
measure: Serious adverse events
timeFrame: after 10 weeks of intervention
measure: Children Organizational Skills Scale (COSS)-parent
timeFrame: 24 weeks after ended intervention
measure: Children Organizational Skills Scale (COSS)-teacher
timeFrame: 24 weeks after ended intervention
measure: ADHD-Rating Scale (ADHD-RS) (parent edition)
timeFrame: 24 weeks after ended intervention
measure: ADHD-Rating Scale (ADHD-RS) (teacher edition)
timeFrame: 24 weeks after ended intervention
measure: Behavior Rating Inventory of Executive Functions (BRIEF)-parent
timeFrame: 24 weeks after ended intervention
measure: Behavior Rating Inventory of Executive Functions (BRIEF)-teacher
timeFrame: 24 weeks after ended intervention
measure: CANTAB Stop Signal Task (SST)
timeFrame: 24 weeks after ended intervention
measure: CANTAB one touch Stockings of Cambridge (SOC)
timeFrame: 24 weeks after ended intervention
measure: CANTAB Rapid Visual Movement (RVP)
timeFrame: 24 weeks after ended intervention
measure: CANTAB Working Memory (WM)
timeFrame: 24 weeks after ended intervention
measure: Weis's scale of disability-Parent Report (WFIRS-P)
timeFrame: 24 weeks after ended intervention
measure: Non-serious adverse events
timeFrame: 24 weeks after ended intervention
measure: Serious adverse events
timeFrame: 24 weeks after ended intervention
measure: CANTAB Reaction time task (RTI)
timeFrame: after 10 weeks of intervention
measure: CANTAB Reaction time task (RTI)
timeFrame: after 24 weeks of intervention
measure: ADHD-Rating Scale (ADHD-RS) (teacher edition)
timeFrame: after 10 weeks of intervention
Locations:
city: Aabenraa
country: Denmark
facility: Department of Child and Adolescent Mental Health Services
city: Vejle
country: Denmark
facility: Department of Child and Adolescent Mental Health Services
Study officials:
affiliation: Region of Southern Denmark and University of Southern Denmark
name: Aida Bikic, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.