• Headache diaries assess headache frequency [ Time Frame: completed every week up to week 20, 1 month prior to 3, 6, 9, and 12 month follow-up ] [ Designated as safety issue: No ]
  
• Pediatric Migraine Disability Assessment (PedMIDAS) evaluates the impact of headaches on life activities. [ Time Frame: completed at baseline, week 20, Month 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
  

• The Child Depression Inventory [ Time Frame: completed at baseline, week 20, Month 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
  
• PedsQL measures the impact of chronic illness and quality of life [ Time Frame: completed at baseline, week 20, Month 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
  

Chronic daily headache (CDH)——defined as having headaches 15 or more days per month——is a frequent and debilitating condition in children that results in severe decreased quality of life and emotional stress. Very little is known about the most effective types of treatment for CDH in children and adolescents. Development of effective interventions for youth with CDH could potentially prevent the progression of a very painful and costly condition into adulthood. Treatments combining pharmacological (drug) interventions with behavior change have been found effective in treating adults with chronic pain, including headaches, but have been understudied in children.

The goal of this randomized, controlled clinical trial is to determine the efficacy of combined behavioral and drug treatment of CDH in youth ages 10 to 17. In the study, scientists will investigate if a combination of pain coping skills training (CST) and the drug amitriptyline (AMI)——CST-AMI——is effective in reducing headache frequency, functional disability, and symptoms of depression. More specifically, the researchers will evaluate if CST-AMI is superior to AMI combined with an attention control (ATT). The CST will mainly focus on learning skills for coping with pain, and the ATT will focus on understanding chronic headaches and lifestyle information.

Participants will be randomly assigned to one of the two treatment groups: CST-AMI or ATT-AMI. Those assigned to CST-AMI will complete 8 weekly sessions of coping training and 2 monthly maintenance-promoting sessions. Sessions will focus on teaching biofeedback, muscle relaxation techniques, imagery, distraction, activity pacing, problem solving, and calming techniques, using a treatment manual developed and tested in youth with CDH. Those assigned to ATT-AMI will receive the same amount of therapist support and attention but not the active behavioral training. All participants will receive the study medication, AMI.

Headache frequency, functional disability, pain and headache characteristics, quality of life, and symptoms of depression will be assessed before and after treatment, and reassessed at 3, 6, 9, and 12 months. For participants, duration of the study——which includes treatment and follow-up phases——lasts about 18 months. The treatment phase includes 12 study visits and the follow-up phase includes 4 study visits.

The long-term objective of this research is to establish effective treatments for CDH in youth that lead to significantly reduced headache frequency and functional disability.