A Study of Family-based Cognitive-behavioral Therapy for Chronic Pediatric Headache and Anxiety
A Study of Family-based Cognitive-behavioral Therapy for Chronic Pediatric Headache and Anxiety
The primary aim of this proposal is to refine the intervention under investigation (i.e.,
 family-based CBT) and evaluate the feasibility and acceptability of the intervention and
 methods (e.g., recruitment, assessments).

 The secondary aim of this proposal is to compare the relative efficacy of an 8 session
 family-based cognitive-behavioral therapy (CBT) to Relaxation Training (RT) for reducing
 anxiety and chronic headaches in youth (N = 30) ages 7-17 years. It is hypothesized that CBT
 will result in greater reductions in both anxiety and headache frequency and severity
 compared to RT.
Chronic daily headache in children, as well as periodic migraine, is a prevalent, persistent,
 and debilitating pain condition affecting nearly 1 in 10 children. Emerging evidence suggests
 that affected youth also experience excessive and impairing symptoms of anxiety which may
 play a role in the etiology and/or maintenance of headache pain. Current behavioral
 treatments are effective in reducing headache frequency and intensity, however, many youth
 remain symptomatic and the exacerbating role of anxiety has largely been ignored. Moreover,
 current psychosocial treatments fail to incorporate parents in the therapeutic process. The
 current proposal is a pilot study designed to address the shortcomings of current behavioral
 treatments by evaluating the initial efficacy of a family-based cognitive-behavioral therapy
 (CBT) for youth who present with chronic tension headaches and migraines, and excessive
 anxiety. Rigorous scientific methods will be employed, including a randomized design,
 multiple informants and measures to assess key constructs, independent evaluators (IEs) to
 assess outcomes, and intensive training for therapists and IEs to assure a high quality of
 implementation. Using a pre-post experimental design, 30 youth with chronic tension headaches
 and/or migraines and anxiety will be randomly assigned to receive 8 weeks of family-based CBT
 or relaxation training (RT). IEs will complete assessments of child symptoms and functioning
 at pre and post-treatment and at one month follow-up. Youth in the family-based CBT condition
 are expected to evince greater reductions in both headache and anxiety frequency, severity,
 and duration. Results from this study will be used to make empirically informed modifications
 to the CBT treatment manual in order to facilitate replication and dissemination of the
 interventions to clinicians and researchers.
Inclusion Criteria:

 -  To determine eligibility, youth will complete an evaluation consisting of clinical
 interviews, self-, and parent-report measures.

 -  To be included in the study, all children must:

 1. have a current diagnosis of chronic daily headache, tension-type headache, and/or
 migraine headache

 2. obtain a total score on the Screen for Child Anxiety Related Disorders (SCARED)
 in the clinical range (i.e., > 20)

 3. be between 7 and 17 years old

 4. have a parent/guardian who gives consent and agrees to participate

 5. be English speaking

 6. not currently participating in other psychosocial treatments specifically
 directed at reducing head pain or anxiety.

 -  For youth receiving prophylactic medication, it is preferable that they remain on a
 stable dose and agree to avoid medication changes while enrolled in the study. Thus,
 all participants will be permitted to continue with their prescribed
 medical/neurological treatment, however the use of medications (both prophylactic and
 over-the-counter analgesics) will be closely monitored.

 Exclusion Criteria:

 -  Youth will be excluded from the study if they have a medical or psychiatric condition
 contraindicating study treatment or warranting an alternative intervention (e.g.,
 suicidality, depression).