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Abstract: Objectives: The Grip on Challenging Behavior care program was developed using the current guidelines and models on managing challenging behavior in dementia in nursing homes. It was hypothesized that the use of the care program would lead to a decrease in challenging behavior and in the prescription of psychoactive drugs without increase in use of restraints. Design: A randomized controlled trial was undertaken using a stepped-wedge design to implement the care program and to evaluate the effects. An assessment of challenging behavior and psychoactive medication was undertaken every 4 months on all participating units followed by the introduction of the care program in a group of 3 to 4 units. A total of 6 time assessments took place over 20 months. Setting: Seventeen dementia special care units of different nursing homes. Participants: A total of 659 residents of dementia special care units. All residents with dementia on the unit were included. Units were assigned by random allocation software to 1 of 5 groups with different starting points for the implementation of the care program. Intervention: A care program consisting of various assessment procedures and tools, which ensure a multidisciplinary approach and which structure the process of managing challenging behavior in dementia. Measurements: Challenging behavior was measured using the Cohen-Mansfield Agitation Inventory (CMAI) and the Neuropsychiatric Inventory. Research assistants (blinded for intervention status of the unit) interviewed nurses on the units about challenging behavior. Data on psychoactive drugs and restraints were retrieved from resident charts. Results: A total of 2292 assessments took place involving 659 residents (1126 control measurements, 1166 intervention measurements). The group of residents who remained in the intervention condition compared with the group in the control condition differed significantly in the CMAI change scores between successive assessments [–2.4 CMAI points, 95% confidence interval (CI) –4.3 to –0.6]. No significant effects were found for the control-to-intervention group compared with the group who remained in the control group (0.0 CMAI points, 95% CI –2.3 to 2.4). Significant effects were found on 5 of the 12 Neuropsychiatric Inventory items and on the use of antipsychotics (odds ratio 0.54, 95% CI 0.37– 0.80) and antidepressants (odds ratio 0.65, 95% CI 0.44–0.94). No effect on use of restraints was observed. Conclusions: The Grip on Challenging behavior program was able to diminish some forms of challenging behavior and the use of psychoactive drugs. [Copyright &y& Elsevier]