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Comfortability Workshop

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ClinicalTrials.gov Identifier: NCT04081454
Recruitment Status : Not yet recruiting
First Posted : September 9, 2019
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment
Chronic Pain Behavioral: Workshop Behavioral: Education

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: The Comfort Ability Workshop: Improving Pain Treatment for Children and Their Families
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Group/Cohort Intervention/treatment
Children with chronic pain Behavioral: Workshop
one-day (6 hour) program to help children and their parents or caregivers learn how to better manage chronic pain

Behavioral: Education
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.

Caregivers of children with chronic pain Behavioral: Workshop
one-day (6 hour) program to help children and their parents or caregivers learn how to better manage chronic pain

Behavioral: Education
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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children aged 11 - 17 with chronic pain and their parents or caregivers
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04081454


Contacts
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Contact: Anne LaBarge, RN, CPNP 314 261-6487 labargea@wustl.edu

Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Jacob AuBuchon, MD Washington University School of Medicine
Publications:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04081454    
Other Study ID Numbers: 201907083
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms