PediatricNCT01182051
A Study of Family-based Cognitive-behavioral Therapy for Chronic Pediatric Headache and Anxiety
A study testing CBT or relaxation training in people with Pediatric and Headache, run by Johns Hopkins University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 7 to 17 years
- What is being tested?
- CBT or relaxation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
- have a current diagnosis of chronic daily headache, tension-type headache, and/or migraine headache
- obtain a total score on the Screen for Child Anxiety Related Disorders (SCARED) in the clinical range (i.e., > 20)
- be between 7 and 17 years old
- have a parent/guardian who gives consent and agrees to participate
Show all 9Show fewer
- be English speaking
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- CBT or relaxation training
- Keywords
- headache, anxiety, pediatric headache and anxiety
- Medical subject headings
- Headache, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT or relaxation trainingBehavioural
8 weeks of CBT or relaxation training.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy | Experimental | 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). Receives: Behavioral: CBT or relaxation training |
| Relaxation Training | Active comparator | RT will consist of progressive muscle relaxation training, diaphragmatic breathing, and thermal biofeedback. Receives: Behavioral: CBT or relaxation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Headache and Anxiety Diary
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.
Measured: Daily for three months
Pediatric Anxiety Rating Scale (PARS)
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.
Measured: 2 months
Secondary outcomes (3)
Pediatric Migraine Disability Assessment (PedMIDAS)
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.
Measured: 2 months
Pediatric Migraine Disability Assessment (PedMIDAS)
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.
Measured: 3 months
Pediatric Anxiety Rating Scale (PARS)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Migraine Research Foundation
- Responsible party
- Principal investigator, Golda S. Ginsburg, Ph.D., Johns Hopkins University
- Investigators
- Golda S Ginsburg, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182051
- Sponsor's protocol ID
- NA-00019444
- Status last verified
- May 2013
- First submitted
- 21 May 2010
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Family-based Cognitive-behavioral Therapy for Treating Chronic Pediatric Headache/Migraine and Comorbid Anxiety
- ClinicalTrials.gov ID
- NCT01182051
- Acronym / sponsor ID
- NA-00019444
- Keywords
- headache, anxiety, pediatric headache and anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Migraine Research Foundation
- Study start
- Mar 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy | Experimental | Behavioral: CBT or relaxation trainingKey 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). |
| Relaxation Training | Active comparator | Behavioral: CBT or relaxation trainingRT will consist of progressive muscle relaxation training, diaphragmatic breathing, and thermal biofeedback. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT or relaxation training8 weeks of CBT or relaxation training. | Behavioural | Cognitive behavioral therapy, Relaxation Training |
Primary outcome
Daily Headache and Anxiety Diary
Time frame: Daily for three months
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
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.
3 secondary outcomes
Pediatric Migraine Disability Assessment (PedMIDAS)
Time frame: 2 months
Pediatric Migraine Disability Assessment (PedMIDAS)
Time frame: 3 months
Pediatric Anxiety Rating Scale (PARS)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Golda S Ginsburg, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT or relaxation training in people with Pediatric and Headache, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Headache and Anxiety Diary (time frame: Daily for three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2013; AzTrials last refreshed its copy on 26 Oct 2026.