Background: Up to 60% of children with Attention-Deficit/Hyperactivity Disorder (ADHD) meet diagnostic criteria\nfor at least one anxiety disorder, including Social, Generalized and/or Separation Disorder. Anxiety in children with\nADHD has been shown to be associated with poorer child and family functioning. Small pilot studies suggest that\ntreating anxiety in children with ADHD using cognitive-behavioral therapy (CBT) has promising benefits. In a fully\npowered randomized controlled trial (RCT), we aim to investigate the efficacy of an existing CBT intervention\nadapted for children with ADHD and comorbid anxiety compared with usual care.\nMethods: This RCT is recruiting children aged 8â??12 years (N = 228) from pediatrician practices in Victoria, Australia.\nEligibility criteria include meeting full diagnostic criteria for ADHD and at least one anxiety disorder (Generalized,\nSeparation or Social). Eligible children are randomized to receive a 10 session CBT intervention (Cool Kids) versus\nusual clinical care from their pediatrician. The intervention focuses on building child and parent skills and strategies\nto manage anxiety and associated impairments including cognitive restructuring and graded exposure. Minor\nadaptations have been made to the delivery of the intervention to meet the needs of children with ADHD\nincluding increased use of visual materials and breaks between activities. The primary outcome is change in the\nproportion of children meeting diagnostic criteria for an anxiety disorder at 5 months randomization. This will be\nassessed via diagnostic interview with the childâ??s parent (Anxiety Disorders Interview Schedule for Children V)\nconducted by a researcher blinded to intervention condition. Secondary outcomes include a range of child\n(e.g., anxiety symptoms, ADHD severity, behavior, quality of life, sleep, cognitive functioning, school attendance) and\nparent (e.g., mental health, parenting behaviors, work attendance) domains of functioning assessed at 5 and 12\nmonths post-randomization. Outcomes will be analyzed using logistic and mixed effects regression.
Loading....