A multicenter, randomized, controlled study of Training Executive, Attention, and Motor Skills (TEAMS) in Danish preschool children with attention-deficit/hyperactivity disorder: Rationale and description of the intervention and study protocol

Background: Attention-deficit/hyperactivity disorder (ADHD) is a highly prevalent neurodevelopmental disorder that is often detected during the preschool years. Neuroimaging data indicate that children with ADHD have brains that are characterized by growth and functional anomalies. Data suggest that the diminution of ADHD symptoms is correlated with improved neural functioning and growth. On the basis of these findings, interventions that target neural growth, which indicates neural development, can possibly lead to a more enduring treatment for ADHD. Training Executive, Attention, and Motor Skills (TEAMS) is a non-pharmacological neurocognitive intervention program that targets preschool children with ADHD. The program is designed to stimulate neurocognitive growth through physical activity and play in combination with psychoeducation and guidance for the parents.Population: Children between the ages of three and six years from Region Zealand in Denmark who have been diagnosed with ADHD are offered participation in the trial. According to a calculation of the strength needed to result in a statistically significant outcome, the estimated group size should be, at minimum, 87 children. On the basis of Region Zealand’s visitation history records, the cohort is expected to include approximately 100 to 120 children.Method: The intervention groups participate in eight weekly group sessions that consist of separate parent and children’s groups. The control groups receive the standard treatment program as outlined by the clinical guidelines of Region Zealand. The ADHD Rating Scale-IV and the Danish version of the Strengths and Difficulties Questionnaire are used to assess ADHD symptom severity before and after the intervention and to monitor the duration of the outcome. A comparative analysis of data from the intervention and control groups will illustrate the study’s results.Study aim: This is a multicenter, randomized, controlled, single-blind, parallel-group study with the primary aims of testing the TEAMS concept and investigating whether the intervention significantly lowers ADHD symptoms and increases the functionality level after the intervention as compared with the control group. A secondary aim is to monitor the duration and endurance of the outcome for six months after the intervention. This study is currently in progress. Full results and conclusions will be reported after the study’s completion in 2015