Headstrong Intervention for Pediatric Headache

Headstrong Intervention for Recurrent Pediatric Headache

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00269581

Enrollment

Registered

2005-12-23

Start date

2004-08-31

Completion date

2010-05-31

Last updated

2012-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Headaches

Keywords

migraine, tension headaches, chronic daily headaches

Brief summary

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

Detailed 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.

Interventions

OTHEREducational CD-rom

Educational CD-Rom

OTHERHeadstrong CD-rom

Headstrong CD-rom

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Years to 12 Years

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

Design outcomes

Primary

Measure	Time frame
Pain, mood, and stress self-rating scales	Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up

Secondary

Measure	Time frame
Quality of life	Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up
Headache-related disability	Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026