Table 2 Trial registration data set
Data category | Information32 |
|---|---|
Primary registry and trial identifying number | ClinicalTrials.gov |
NCT03160378 | |
Date of registration in primary registry | May 19, 2017 |
Secondary identifying numbers | S-20160180, ID 17/7467 |
Source(s) of monetary or material support | Psychiatric Research Foundation in Region of Southern Denmark and Jascha Fonden |
Primary sponsor | Psychiatric Research Foundation in Region of Southern Denmark |
Secondary sponsor(s) | Jascha Fonden |
Contact for public queries | Aida Bikic e-mail: aida.bikic@rsyd.dk |
Contact for scientific queries | Aida Bikic e-mail: aida.bikic@rsyd.dk |
University of Southern Denmark, Odense, Denmark | |
Scientific title | Organizational skills training for children with ADHD |
Countries of recruitment | Denmark |
Health condition(s) or problem(s) studied | Attention Deficit Hyperactivity Disorder (ADHD) |
Intervention(s) | Active comparator: Organizational skills training (OST), a group treatment for families |
Control group: Treatment as usual (TAU) | |
Key inclusion and exclusion criteria | Ages eligible for study: 6-13 years |
Sexes eligible for study: both | |
Accepts healthy volunteers: no | |
Inclusion criteria: child age 6-13 years, ADHD diagnosis, organizational skills deficits | |
Exclusion criteria: autism spectrum disorders, 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. | |
Study type | Interventional |
Allocation: randomized intervention model. Parallel assignment masking: investigator and outcomes assessor are blinded. | |
Primary purpose: treatment | |
Phase III | |
Date of first enrolment | May 22, 2017. |
Estimated primary completion date | June 2022 |
Estimated study completion date | December 2022 |
Target sample size | 142 |
Recruitment status | Recruiting |
Primary outcome(s) | Total score on the Parent-rated behavior Children Organizational Skills Scale (COSS) |
Key secondary outcomes | • CANTAB Rapid Visual Information Processing (RVP) • Children Organizational Skills Scale (COSS) (teacher edition)-total • Inattention subscale assessed by ADHD-Rating Scale (ADHD- RS-IV) (parent edition). • Behavior Rating Inventory of Executive Functions (BRIEF) organize subscale (parent edition). • Weiss scale of disability-Parent Report (WFIRS-P) |