Obsessive-Compulsive Disorder in Children Clinical Trial
Official title:
Cognitive Control Targets for the Treatment of Obsessive Compulsive Disorder in Young Children
This study aims to examine the effects of a game-like program called cognitive control training (CT) for children with obsessive compulsive disorder (OCD). Children enrolled in this study will receive 4 weeks of the at-home computerized cognitive training program (AKL-T01) delivered on iPad (25 minutes/day, 5 days/week). Styled as a child-friendly video game, AKL-T01 CT taps focused attention, response inhibition, and working memory using a series of games to engage cognitive control processes. Children will complete the NIH Toolbox prior to, mid (2-weeks), and post-CT (4-weeks). Participants will complete MRI scans pre- and post-CT and then be offered a 12-week course of gold-standard Cognitive behavioral therapy with exposure and response prevention (or community referrals) after CT. The long-term goal of this study is to test how this CT intervention may enhance cognitive control capacity to reduce symptoms and improve response to cognitive behavioral therapy with exposure and response prevention in children with OCD.
Obsessive-Compulsive Disorder (OCD) often onsets in childhood and, if not effectively treated, can lead to lifelong illness and poor functional outcomes. Cognitive behavioral therapy (CBT) with exposure and response prevention (EXRP) is the gold-standard, first-line treatment for children with OCD. However, as many as 40% of pediatric patients treated fail to remit. Based on the extant literature and our preliminary data showing that cognitive control functions are altered in children with OCD, this study is designed to test the hypothesis that cognitive control training (CT) should engage the Cognitive System to prime and augment EXRP response. A 2-year proof of concept study will be conducted to determine if CT enhances cognitive control behavioral performance (target engagement) in 60 children (8-12 years old) with OCD sampled from the general community and affiliated clinics. Children will receive 4 weeks of an at-home computerized cognitive training program (AKL-T01; FDA-approved for pediatric ADHD) delivered on iPad (25 minutes/day, 5 days/week). Styled as a child-friendly video game, AKL-T01 CT taps focused attention, response inhibition, and working memory using a series of games with individually titrated difficulty to engage cognitive control processes. Children will complete the NIH Toolbox prior to, mid (2-weeks), and post-CT (4-weeks). Cognitive control behavior will be indexed by NIH Toolbox Cognitive Function Composite. Participants will complete MRI scans pre- and post-CT and then be offered a 12-week course of gold-standard CBT EXRP (or community referrals) after CT. Resting state functional connectivity between task control networks and the Default Mode Network will be explored as a potential mechanism of action. ;
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