Clinical trial NCT04081454: Comfortability Workshop
Official title: The Comfort Ability Workshop: Improving Pain Treatment for Children and Their Families
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 13
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 11 - 17 with chronic pain and their parents or caregivers

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 11 years to 17 years
2. Ability to provide informed consent

Exclusion Criteria:

1. Cognitive Delay that may impact completion of questionnaires and involvement of youth group at workshop.
2. Families without access to internet to complete 1 week, 1 month and 3 month follow up questionnaires.

Primary outcomes:
measure: Assess the efficacy of this program in change of pain interference: PROMIS
timeFrame: up to 3 months after workshop
measure: Assess the efficacy of this program in change of pain interference: Pain Self Efficacy Scal - Adolescent
timeFrame: up to 3 months after workshop
measure: Assess the efficacy of this program in change of pain interference: Functional Disability Inventory
timeFrame: up to 3 months after workshop
measure: Assess the efficacy of this program in change of pain interference: Post-Workshop Questionnaire for Parent/Caregiver
timeFrame: up to 3 months after workshop
measure: Assess the efficacy of this program in change of pain interference: Pain Catastrophizing Scale
timeFrame: up to 3 months after workshop
measure: Assess the efficacy of this program in change of pain interference: Pediatric Pain Screen Tool
timeFrame: up to 3 months after workshop
measure: Assess the efficacy of this program in change of pain interference: Treatment History Questionnaire
timeFrame: up to 2 weeks before workshop
measure: Assess the efficacy of this program in change of pain interference: Adult Responses to Children's Symptoms
timeFrame: up to 3 months after workshop
measure: Assess the efficacy of this program in change of pain interference: Pain Self Efficacy Scale - Child
timeFrame: up to 3 months after workshop
measure: Determine if the workshop increases children's pain self-efficacy and improves patients function at our institution: PROMIS
timeFrame: Up to 3 months following workshop
measure: Determine if the workshop increases children's pain self-efficacy and improves patients function at our institution: Post-Workshop Questionnaire for Parent/Caregiver
timeFrame: up to 3 months after workshop
measure: Determine if the workshop increases children's pain self-efficacy and improves patients function at our institution: Functional Disability
timeFrame: Up to 3 months following workshop
measure: Determine if the workshop increases parental management strategies of their child's pain at our institution: PROMIS
timeFrame: Up to 3 months following workshop
measure: Determine if the workshop increases parental management strategies of their child's pain at our institution: Pain Evaluation Questionnaire
timeFrame: Up to 3 months following workshop
measure: Determine if the workshop increases parental management strategies of their child's pain at our institution: Functional Disability
timeFrame: Up to 3 months following workshop
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine/Barnes Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jacob AuBuchon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coakley R, Wihak T, Kossowsky J, Iversen C, Donado C. The Comfort Ability Pain Management Workshop: A Preliminary, Nonrandomized Investigation of a Brief, Cognitive, Biobehavioral, and Parent Training Intervention for Pediatric Chronic Pain. J Pediatr Psychol. 2018 Apr 1;43(3):252-265. doi: 10.1093/jpepsy/jsx112.
citation: Perquin CW, Hazebroek-Kampschreur AA, Hunfeld JA, van Suijlekom-Smit LW, Passchier J, van der Wouden JC. Chronic pain among children and adolescents: physician consultation and medication use. Clin J Pain. 2000 Sep;16(3):229-35. doi: 10.1097/00002508-200009000-00008.
citation: Roth-Isigkeit A, Thyen U, Raspe HH, Stoven H, Schmucker P. Reports of pain among German children and adolescents: an epidemiological study. Acta Paediatr. 2004 Feb;93(2):258-63.