ADHD
Conditions
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.
Interventions
BEHAVIORALOrganizational skills training
10 sessions of parent and child training in a group format.
OTHERTreatment as usual
Treatment as usual in the outpatient clinic
Sponsors
Region Syddanmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Children Organizational Skills Scale (COSS)-parent | after 10 weeks of intervention | organizational skills questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Children Organizational Skills Scale (COSS)-teacher | after 10 weeks of intervention | organizational skills questionnaire |
| ADHD-Rating Scale (ADHD-RS) (parent edition) | after 10 weeks of intervention | ADHD symptoms questionnaire |
| Behavior Rating Inventory of Executive Functions (BRIEF)-parent | after 10 weeks of intervention | executive functions questionnaire |
| CANTAB Rapid Visual Movement (RVP) | after 10 weeks of intervention | cognitive test |
| Weis's scale of disability-Parent Report (WFIRS-P) | after 10 weeks of intervention | functional outcome questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Children Organizational Skills Scale (COSS)-parent | 24 weeks after ended intervention | organizational skills questionnaire |
| Children Organizational Skills Scale (COSS)-teacher | 24 weeks after ended intervention | organizational skills questionnaire |
| ADHD-Rating Scale (ADHD-RS) (parent edition) | 24 weeks after ended intervention | ADHD symptoms questionnaire |
| ADHD-Rating Scale (ADHD-RS) (teacher edition) | 24 weeks after ended intervention | ADHD symptoms questionnaire |
| Behavior Rating Inventory of Executive Functions (BRIEF)-teacher | after 10 weeks of intervention | executive functions questionnaire |
| CANTAB Rapid Visual Movement (RVP) | 24 weeks after ended intervention | cognitive test |
| Weis's scale of disability-Parent Report (WFIRS-P) | 24 weeks after ended intervention | functional outcome questionnaire |
| CANTAB Reaction time task (RTI) | after 10 weeks of intervention | reaction time |
| Behavior Rating Inventory of Executive Functions (BRIEF)-parent | 24 weeks after ended intervention | executive functions questionnaire |
| CANTAB Stop Signal Task (SST) | after 10 weeks of intervention | cognitive test |
| CANTAB one touch Stockings of Cambridge (SOC) | after 10 weeks of intervention | cognitive test |
| CANTAB Working Memory (WM) | after 10 weeks of intervention | cognitive test |
| Non-serious adverse events | after 10 weeks of intervention | adverse events |
| Serious adverse events | after 10 weeks of intervention | adverse events |
Countries
Denmark
Contacts
Primary ContactAida Bikic, Ph.D.
Backup ContactSøren Dalsgaard, MD, Ph.D.
Outcome results
None listed