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Completed

NCT Number: NCT04081454

Comfortability Workshop

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine/Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 11 years to 17 years
  • Ability to provide informed consent

Exclusion criteria

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

Treatment and study plan

Workshop

Behavioral

one-day (6 hour) program to help children and their parents or caregivers learn how to better manage chronic pain

Education

Behavioral

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.

Primary outcomes

  1. Assess the efficacy of this program in change of pain interference: PROMIS

    Time frame: up to 3 months after workshop

    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

  2. Assess the efficacy of this program in change of pain interference: Pain Self Efficacy Scal - Adolescent

    Time frame: up to 3 months after workshop

    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

  3. Assess the efficacy of this program in change of pain interference: Functional Disability Inventory

    Time frame: up to 3 months after workshop

    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

  4. Assess the efficacy of this program in change of pain interference: Post-Workshop Questionnaire for Parent/Caregiver

    Time frame: up to 3 months after workshop

    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

  5. Assess the efficacy of this program in change of pain interference: Pain Catastrophizing Scale

    Time frame: up to 3 months after workshop

    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

  6. Assess the efficacy of this program in change of pain interference: Pediatric Pain Screen Tool

    Time frame: up to 3 months after workshop

    Assess child's pain location and interference in daily life. Yes/No answers

  7. Assess the efficacy of this program in change of pain interference: Treatment History Questionnaire

    Time frame: up to 2 weeks before workshop

    Questionnaire to capture demographics, medical history, goals of treatment

  8. Assess the efficacy of this program in change of pain interference: Adult Responses to Children's Symptoms

    Time frame: up to 3 months after workshop

    Parent/Caregiver questionnaire to assess child's symptoms. Scale of 0 - 5, with 0=never and 5=often

  9. Assess the efficacy of this program in change of pain interference: Pain Self Efficacy Scale - Child

    Time frame: up to 3 months after workshop

    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

  10. Determine if the workshop increases children's pain self-efficacy and improves patients function at our institution: PROMIS

    Time frame: Up to 3 months following workshop

    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

  11. Determine if the workshop increases children's pain self-efficacy and improves patients function at our institution: Post-Workshop Questionnaire for Parent/Caregiver

    Time frame: up to 3 months after workshop

    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

  12. Determine if the workshop increases children's pain self-efficacy and improves patients function at our institution: Functional Disability

    Time frame: Up to 3 months following workshop

    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

  13. Determine if the workshop increases parental management strategies of their child's pain at our institution: PROMIS

    Time frame: Up to 3 months following workshop

    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

  14. Determine if the workshop increases parental management strategies of their child's pain at our institution: Pain Evaluation Questionnaire

    Time frame: Up to 3 months following workshop

    Use of questionnaires to measure parental management strategies.

  15. Determine if the workshop increases parental management strategies of their child's pain at our institution: Functional Disability

    Time frame: Up to 3 months following workshop

    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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

The Comfort Ability Workshop: Improving Pain Treatment for Children and Their Families

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 9, 2019
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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