Organizational skills training for children with ADHD: study protocol for a randomized, controlled trial

Aida Bikic, Søren Dalsgaard, Kristoffer Dalsgaard Olsen, Denis G Sukhodolsky, Aida Bikic, Søren Dalsgaard, Kristoffer Dalsgaard Olsen, Denis G Sukhodolsky

Abstract

Background: Problems with sustained attention, impulsivity, and hyperactivity are the most prominent symptoms of attention-deficit hyperactivity disorder (ADHD), but many children with this diagnosis also present with poor organizational skills that are important in relation to school. These problems tend to increase from childhood to adolescence and are often not well managed by medication. Organizational skills training (OST) is a range of behavioral interventions that specifically target organizational skills deficits. Evidence supports the effect of OST on improving organizational skills, inattention, and academic performance in children with ADHD. Because previous clinical trials included mostly children above the age of 8 years, this trial includes children in the age range 6-13 years to expand the knowledge on the effects of OST in younger children. Previous OST research has also shown improvement on inattention in parent ratings; we will investigate if a change in inattention can be confirmed with neurocognitive tests. Finally, little is known about predictors of treatment response in OST.

Objectives: The primary objective is to investigate if OST has positive effects on organizational skills in children with ADHD. The primary outcome measurement is the parent-rated Children's Organizational Skills Scale (COSS), collected before and at the end of the 10 week intervention. Secondary and exploratory outcomes include inattention ratings, family and school functioning, and cognitive functions measured before the intervention period, immediately after, and at a 6 month follow-up. Additional objectives are to investigate both neurocognitive outcomes and age as predictors of treatment response.

Methods: This is a randomized clinical superiority trial investigating the effect of OST vs a treatment-as-usual (TAU) control group for children with ADHD in the age range of 6-13 years. All participants (n = 142) receive TAU. OST is administered in a group format of 10 weekly sessions. Adverse events are monitored by study clinicians during weekly therapy sessions and all assessments. Data analyses will be conducted using mixed linear regression models with random intercepts for patients, adjusted for the stratification variables and the baseline value.

Perspectives: This study will provide important new knowledge and expand on existing research in the field of non-pharmacological treatment of children with ADHD. OST can potentially have a significant impact on the lives of children with ADHD by helping them learn how to cope with their present deficits and to become more independent and self-reliant. It is also important to investigate predictors of treatment response in order to optimize OST.

Trial registration: ClinicalTrials.gov NCT03160378 . Registered on May 19, 2017.

Keywords: ADHD; Executive functions; Organizational difficulties; Organizational skills training.

Conflict of interest statement

Principal investigator and other authors: none

Dr. Dalsgaard’s research is supported by grants from The Lundbeck Foundation (iPSYCH grant no R248-2017-2003), Novo Nordisk Foundation (grant no 22018), Helsefonden (grant no 19-8-0260), and the European Union’s Horizon 2020 research and innovation program under grant agreements No 667302 and No 847879.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
CONSORT flow diagram. Flowchart on participant enrollment and the randomization process
Fig. 2
Fig. 2
Timeline of assessment phases in the trial. (1) BRIEF, Behavior Rating Inventory of Executive Functions. P, parent. T, teacher; (2) K-SADS, Kiddie-Schedule for Affective Disorders and Schizophrenia; (3) RIAS, Reynolds Intellectual Assessment Scales; (4) CANTAB, Cambridge Automated Neurocognitive Test Battery; (5) COSS, Children’s Organizational Skills Scales. P, parent. T, teacher; (6) ADHD-RS, Attention Deficit Hyperactivity Disorder-Rating Scale. P, parent. T, teacher; (7) WFIRS-P, Weiss scale of disability Parent Report; (8) OST, Organizational Skills Training TAU; and (9) treatment as usual

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