An observational study in Chronic Pain, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by Washington University School of Medicine · Observational
The Comfort Ability is a fun and interactive one-day (6 hour) program to help children and their parents or caregivers learn how to better manage chronic pain. The program introduces cognitive-behavioral and bio-behavioral pain management strategies to emphasize the mind-body connection and offers non-invasive and non-pharmaceutical strategies for improved pain management. Youth ages 11-18 with chronic or recurrent pain are eligible to sign up for Comfort Ability.
This 1-day, manualized clinical intervention includes a parent group and an adolescent group that run simultaneously, but separately. This program will be offered 4 times per calendar year. The program is 6-hours long and was run at an urban, Midwest children's hospital on a weekend day to maximize accessibility for families. Each group will include between 8 and 12 adolescents (ages 11-17 years) and 15-21 parents. The groups will be staffed by two PhD-level psychologists (one for the parent and one for the adolescent group), a psychology postdoctoral fellow, and nurse practitioner, one or two trained study assistants (e.g., psychology interns, nurse coordinator) who provide support, but not intervention content.
The adolescent program includes motivational interviewing, psychoeducation, and structured activities that emphasize the link between pain, negative cognitions (i.e., catastrophizing), avoidance behaviors, and mood. About one third of the day is devoted to in vivo practice of relaxation-based skills including diaphragmatic breathing, guided imagery, pain-reduction visualization, and biofeedback. Additionally, adolescents participate in several hands-on activities designed to enhance mind-body regulation including mindfulness practice (eating mindfully), art therapy, and aromatherapy. Adolescents complete interactive workbooks throughout the program; at the end of the day, each adolescent works one-on-one with staff to create a written and personalized pain management plan emphasizing the adaptive coping strategies each adolescent preferred during the day. Adolescents were additionally provided with a pain management tool kit inclusive of recorded relaxation exercises, a biofeedback card, and other small tools to enhance their pain management regimen.
The parent program includes psychoeducation regarding pain in the context of adolescent development, didactic and vignette-based practice of an adaptive parent communication response style (i.e., reflective listening), and concrete tools for setting up behavior plans to scaffold an adolescent's return to function for school, sleep, daily activities, and exercise. All parents are provided with a take-home workbook inclusive of neuroscience and psychoeducational materials as well as a list of resources to further solidify the information they learned.
In addition there will be peer support for parents and adolescents in this program. During the 1 day intervention families and youth will be encouraged to share discussions regarding their health journeys. A guest speaker will be invited to both groups sharing their experiences and journey of utilizing psychologically based interventions to assist with reducing pain and stress and associated disability. These speakers have not received training for this portion.
2,999 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.
This study's enrollment of 13 is below the median of 128 across 706 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →Washington University School of Medicine is the lead sponsor of 1,795 studies on the registry; 270 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 216 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children aged 11 - 17 with chronic pain and their parents or caregivers
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Behavioral: Workshop · Behavioral: Education
Behavioral: Workshop · Behavioral: Education
one-day (6 hour) program to help children and their parents or caregivers learn how to better manage chronic pain
The parent program includes psychoeducation regarding pain in the context of adolescent development, didactic and vignette-based practice of an adaptive parent communication response style (i.e., reflective listening), and concrete tools for setting up behavior plans to scaffold an adolescent's return to function for school, sleep, daily activities, and exercise. All parents are provided with a take-home workbook inclusive of neuroscience and psychoeducational materials as well as a list of resources to further solidify the information they learned.
Assess the efficacy of this program in change of pain interference: PROMIS
Pediatric pain interference over the past 7 days on scale of 1 - 5. 1=Never, 2=Almost Never, 3=Sometimes, 4=Often, 5=Almost Always
Time frame: up to 3 months after workshop
Assess the efficacy of this program in change of pain interference: Pain Self Efficacy Scal - Adolescent
Questionnaire to assess confidence with doing daily tasks when in pain. Scale of 1-5. 1=very sure, 2=pretty sure, 3=in the middle, 4=pretty unsure, 5=very unsure
Time frame: up to 3 months after workshop
Assess the efficacy of this program in change of pain interference: Functional Disability Inventory
Questionnaire relating to difficulty of doing regular activities. Scale of 0 - 4. 0=no trouble, 1=a little trouble, 2=some trouble, 3=a lot of trouble, 4=impossible
Time frame: up to 3 months after workshop
Assess the efficacy of this program in change of pain interference: Post-Workshop Questionnaire for Parent/Caregiver
Use of questionnaire to measure child's opinion of eductional material during workshop. Scale of 1 -5. 1=Strongly disagree, 2=disagree, 3=unsure, 4=Agree, 5=Strongly Agree
Time frame: up to 3 months after workshop
Assess the efficacy of this program in change of pain interference: Pain Catastrophizing Scale
Assess thoughts and feelings when participant is in pain. Scale 0-4. 0=Not at all, 1=to a slight degree, 2=to a moderate degree, 3=to a great degree, 4=all the time
Time frame: up to 3 months after workshop
Assess the efficacy of this program in change of pain interference: Pediatric Pain Screen Tool
Assess child's pain location and interference in daily life. Yes/No answers
Time frame: up to 3 months after workshop
Assess the efficacy of this program in change of pain interference: Treatment History Questionnaire
Questionnaire to capture demographics, medical history, goals of treatment
Time frame: up to 2 weeks before workshop
Assess the efficacy of this program in change of pain interference: Adult Responses to Children's Symptoms
Parent/Caregiver questionnaire to assess child's symptoms. Scale of 0 - 5, with 0=never and 5=often
Time frame: up to 3 months after workshop
Assess the efficacy of this program in change of pain interference: Pain Self Efficacy Scale - Child
Questionnaire to assess confidence with doing daily tasks when in pain. Scale of 1-5. 1=very sure, 2=pretty sure, 3=in the middle, 4=pretty unsure, 5=very unsure
Time frame: up to 3 months after workshop
Determine if the workshop increases children's pain self-efficacy and improves patients function at our institution: PROMIS
Pediatric pain interference over the past 7 days on scale of 1 - 5. 1=Never, 2=Almost Never, 3=Sometimes, 4=Often, 5=Almost Always
Time frame: Up to 3 months following workshop
Determine if the workshop increases children's pain self-efficacy and improves patients function at our institution: Post-Workshop Questionnaire for Parent/Caregiver
Use of questionnaire to measure parent/caregiver's opinion of eductional material during workshop. Scale of 1 -5. 1=Strongly disagree, 2=disagree, 3=unsure, 4=Agree, 5=Strongly Agree
Time frame: up to 3 months after workshop
Determine if the workshop increases children's pain self-efficacy and improves patients function at our institution: Functional Disability
Questionnaire relating to difficulty of doing regular activities. Scale of 0 - 4. 0=no trouble, 1=a little trouble, 2=some trouble, 3=a lot of trouble, 4=impossible
Time frame: Up to 3 months following workshop
Determine if the workshop increases parental management strategies of their child's pain at our institution: PROMIS
Pediatric pain interference over the past 7 days on scale of 1 - 5. 1=Never, 2=Almost Never, 3=Sometimes, 4=Often, 5=Almost Always
Time frame: Up to 3 months following workshop
Determine if the workshop increases parental management strategies of their child's pain at our institution: Pain Evaluation Questionnaire
Use of questionnaires to measure parental management strategies.
Time frame: Up to 3 months following workshop
Determine if the workshop increases parental management strategies of their child's pain at our institution: Functional Disability
Questionnaire relating to difficulty of doing regular activities. Scale of 0 - 4. 0=no trouble, 1=a little trouble, 2=some trouble, 3=a lot of trouble, 4=impossible
Time frame: Up to 3 months following workshop
Plan to share: No
Ran from Aug 2021 to primary completion in Dec 2023, 28 months.
Of 325 non-industry observational studies under Chronic Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 54. This study's 28 months is above that.
Counting every sponsor, half of 350 studies reached it within 25 months; a quarter within 12 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Washington University School of Medicine →