A Study of Family-based Cognitive-behavioral Therapy for Chronic Pediatric Headache and Anxiety

This study has been completed.
Sponsor:
Collaborator:
Migraine Research Foundation
Information provided by (Responsible Party):
Golda S. Ginsburg, Ph.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01182051
First received: May 21, 2010
Last updated: May 22, 2013
Last verified: May 2013

May 21, 2010
May 22, 2013
March 2010
June 2012   (final data collection date for primary outcome measure)
  • Daily Headache and Anxiety Diary [ Time Frame: Daily for three months ] [ Designated as safety issue: No ]
    Youth and parents will complete a daily headache and anxiety diary to track the frequency and severity of headaches and anxiety symptoms. In addition, the diary will assess medication use, missed school/activities, as well as antecedents and consequences.
  • Pediatric Anxiety Rating Scale (PARS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The Pediatric Anxiety Rating Scale (PARS) will be completed by an independent evaluator to assess the severity of current (within the past week) anxiety symptoms in youth. The instrument consists of two sections. The first section contains a 50-item anxiety symptoms checklist. The second section assesses the severity and impairment of these symptoms. A total score is computed by summing the severity items. The measure has acceptable internal consistency, reliability, and convergent/divergent validity.
  • Daily Headache Diary [ Time Frame: Pre-treatment, post-treatment, one-month follow-up ] [ Designated as safety issue: No ]
    Youth and parents will complete a daily headache diary to track the frequency and severity of headache episodes. In addition, the diary will assess medication use, missed school/activities, as well as headache antecedents and consequences.
  • Pediatric Anxiety Rating Scale [ Time Frame: Pre-treatment, post-treatment, one month follow-up ] [ Designated as safety issue: No ]
    The PARS will be completed by the IE to assess the severity of current (within the past week) anxiety symptoms in youth. The instrument consists of two sections. The first section contains a 50-item anxiety symptoms checklist. The second section assesses the severity and impairment of these symptoms. A total score is computed by summing the severity items. The measure has acceptable internal consistency, reliability, and convergent/divergent validity (RUPP Anxiety Study Group, 2002).
Complete list of historical versions of study NCT01182051 on ClinicalTrials.gov Archive Site
  • Pediatric Migraine Disability Assessment (PedMIDAS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The Pediatric Migraine Disability Assessment (PedMIDAS) is used to assess migraine disability across multiple domains of functioning including school, home, social, and recreational. The measure consists of 6 items measuring the number of days in which activities were missed as a result of headache/migraine. The measure yields a total score by summing items. Total scores correspond to one of four "disability grades:" 0-10 = little to no disability, 11-30 = mild disability, 31-50 = moderate disability, and >50 = severe disability.
  • Pediatric Migraine Disability Assessment (PedMIDAS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The Pediatric Migraine Disability Assessment (PedMIDAS) is used to assess migraine disability across multiple domains of functioning including school, home, social, and recreational. The measure consists of 6 items measuring the number of days in which activities were missed as a result of headache/migraine. The measure yields a total score by summing items. Total scores correspond to one of four "disability grades:" 0-10 = little to no disability, 11-30 = mild disability, 31-50 = moderate disability, and >50 = severe disability.
  • Pediatric Anxiety Rating Scale (PARS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The Pediatric Anxiety Rating Scale (PARS) will be completed by an independent evaluator to assess the severity of current (within the past week) anxiety symptoms in youth. The instrument consists of two sections. The first section contains a 50-item anxiety symptoms checklist. The second section assesses the severity and impairment of these symptoms. A total score is computed by summing the severity items. The measure has acceptable internal consistency, reliability, and convergent/divergent validity.
Pediatric Migraine Disability Assessment (PedMIDAS) [ Time Frame: Pre-treatment, post-treatment, one month follow-up ] [ Designated as safety issue: No ]
The PedMIDAS is a child version of the extensively used Migraine Disability Assessment (MIDAS) tool and is used to assess pediatric migraine disability across multiple domains of functioning including school, home, social, and recreational. The measure consists of 6 items measuring the number of days in which activities were missed as a result of headache/migraine. The measure yields a total score by summing items. Total scores correspond to one of four "disability grades:" 0-10 = little to no disability, 11-30 = mild disability, 31-50 = moderate disability, and >50 = severe disability.
Not Provided
Not Provided
 
A Study of Family-based Cognitive-behavioral Therapy for Chronic Pediatric Headache and Anxiety
A Pilot Study of Family-based Cognitive-behavioral Therapy for Treating Chronic Pediatric Headache/Migraine and Comorbid 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Pediatric
  • Headache
  • Anxiety
Behavioral: CBT or relaxation training
8 weeks of CBT or relaxation training.
  • Experimental: Cognitive behavioral therapy
    Key treatment ingredients in CBT include psychoeducation, trigger identification, progressive muscle relaxation training, cognitive restructuring, problem solving, in vivo exposure, and relapse prevention (see Appendix I for an outline of the treatment manual).
    Intervention: Behavioral: CBT or relaxation training
  • Active Comparator: Relaxation Training
    RT will consist of progressive muscle relaxation training, diaphragmatic breathing, and thermal biofeedback.
    Intervention: Behavioral: CBT or relaxation training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
June 2012
June 2012   (final data collection date for primary outcome measure)

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).
Both
7 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01182051
NA-00019444
No
Golda S. Ginsburg, Ph.D., Johns Hopkins University
Johns Hopkins University
Migraine Research Foundation
Principal Investigator: Golda S Ginsburg, Ph.D. Johns Hopkins University
Johns Hopkins University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP