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Headstrong Intervention for Pediatric Headache

M

Michael Rapoff, Ph.D.

Status and phase

Completed
Phase 3

Conditions

Chronic Headaches

Treatments

Other: Headstrong CD-rom
Other: Educational CD-rom

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00269581
9578
NS46641

Details and patient eligibility

About

Purpose of this study is to determine if a CD-ROM computer program (called "Headstrong") is effective in helping children cope with chronic headaches.

Full description

Children, 7-12 years, with recurrent headaches are randomly assigned to an educational CD-ROM program or the Headstrong CD-ROM program. We anticipate that those assigned to the active (Headstrong) program group will have significantly greater reductions in headache frequency, duration, and severity and improvements in mood and quality of life.

Enrollment

35 patients

Sex

All

Ages

7 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 7-12 years of age
  • having recurrent, intermittent, nonmalignant headaches occurring on an average of at least once per week by parental or child report and separated by symptom-free periods
  • having a diagnosis by a nurse practitioner, pediatrician, or pediatric neurologist of migraine, muscle-contraction, or chronic daily headaches

Exclusion criteria

  • their medical history and/or neurological exam suggests that headaches are secondary to another physical or developmental condition
  • their parents report they have been diagnosed with a mental health condition or they are receiving concurrent psychotherapy
  • their baseline headache diaries indicate an average headache frequency of less than one per week

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

35 participants in 2 patient groups

1
Other group
Description:
Educational CD-Rom
Treatment:
Other: Educational CD-rom
2
Experimental group
Description:
Headstrong CD-rom
Treatment:
Other: Headstrong CD-rom

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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