Internalizing symptoms, associated behaviors and family-level risk factors for treatment response in pediatric migraine: a cohort study

Summary

Background: Unfortunately, between 40-65% of children and adolescents with migraine do not respond to the current standard of care treatments. In order to advance treatment options for this group, we must first understand if there are predictors of treatment course in children and adolescents with migraine. Preliminary studies have shown that depression might be predictive of a poor treatment response. However, there is a lot about this that is still unknown.

Hypothesis: We hypothesize that internalizing symptoms (i.e., anxiety, depression and post-traumatic symptoms) and related behaviors (i.e., sleep) in both youth with migraine and their parents will be predictive of treatment response and disability.

Methods: A variety of complimentary research methods will be used to measure internalizing symptoms and related behaviors and migraine-specific outcomes at various time points. A sample of 25 children and adolescents with migraine, and one of their parents, will be recruited for the pilot phase. We aim to recruit a total of 225 children and adolescents with migraine, along with one parent, throughout the entire study. First, participants and their parents will complete baseline questionnaires about their headaches, internalizing symptoms and related behaviors. Then, each participant and their parent will enter a 30-day baseline phase, during which time they will complete a daily headache, mood, anxiety and stress diary. Patient participants will also wear an actigraph, a device that is worn on the wrist to monitor activity and estimates sleep-wake patterns with a built-in movement sensor. Following the 30-day baseline period, participants and their parent will be invited for a study visit where we will observe their interactions (discussing a past migraine episode) and apply an established behavioral coding scheme to discern maladaptive style, content, and tone reflective of overprotective parenting. Following the study visit, follow-up questionnaires will be sent at three months, one year and two years. These questionnaires will assess interim headache history and internalizing symptoms and related behaviors. All of the questionnaires will be sent through auto-generated emails with embedded questionnaire links, or through text messaged links.

Significance: This study will be the first to look at specific modifiable risk factors over time for the maintenance and progression of this often lifelong, debilitating condition in a sample of children and adolescents. In so doing, this work has the potential to uncover advanced treatment approaches for these vulnerable youth.

Eligibility

Currently recruiting participants: Yes

Eligible gender: Male, Female, Transgender, Other

Eligible ages: 8 to 18

Inclusion criteria:

We are aiming to enroll 225 children and adolescents with the following characteristics. We will also include one of their parents in the study.

Characteristics of eligible children and adolescents:
1. A diagnosis of migraine using the International Classification of Headache Disorders 3rd edition criteria
2. At least 4 headache days per month
3. Aged 8.0-18.0 years
4. Proficient in English language

Exclusion criteria:

Children and adolescents with the following characteristics will not be eligible for this study:
1. Significant medical diagnosis (e.g., cancer, systemic lupus erythematosus)
2. Psychotic disorder
3. Significant global developmental delay or intellectual disability
4. Lack of access to the internet

Participate

This study is not currently accepting expressions of interest via the website. Please see contact information below.

Additional information

Contact information

Recruitment is through the Alberta Children's Hospital Headache Clinic in Neurology and through the Alberta Children's Hospital Headache Self-Management Clinic

Principal investigator:

Serena Orr

Clinical trial:

No

REB-ID:

REB19-1315