Building Adaptive Coping and Knowledge to Improve Daily Life

NCT04602728 | Completed Results

• 3 other identifiers: STUDY000005731K23HL133457R03HL164333
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to find out how teenagers with chronic pain and sickle cell disease respond to a new training program called Back2Life and get their feedback about how to modify the program to best fit their needs. The Back2Life training program focuses on teaching pain coping skills (also known as cognitive-behavioral therapy). The program teaches skills and strategies that may help teens improve chronic pain management and get back into their everyday activities.

Conditions

Sickle Cell Disease

Keywords

Pediatrics; Cognitive behavioral therapy; Behavioral intervention

Outcome Measures

Primary Outcomes (8)

• Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Short Form Pain Interference Score

  The PROMIS Pediatric Short Form for Pain Interference, Self- and Parent-Proxy Report, is an 8-item self-report measure assessing functional interference due to pain in the past 7 days. Total scores are standardized to a T-score with a mean of 50 and a standard deviation of 10, where higher scores indicate increased hindrance of life activities due to pain.

  Baseline, Immediately Post-Treatment, Month 3, Month 6

• Sickle Cell Disease Pain Burden Interview-Youth (SCPBI-Y) Score

  The Sickle Cell Pain Burden Interview for Youth, Self-Report is a 7-item, validated measure of pain burden in 7-21 year olds. Responses are given on a 5-point Likert scale where 0 = none and 4 = every. The patient self-reports the amount of days in the past month where pain occurred or pain impacted daily life. Total scores range from 0 to 28 and higher scores indicate a greater pain burden.

  Baseline, Immediately Post-Treatment, Month 3, Month 6

• PROMIS Pediatric Short Form Pain Behaviors, Parent-Proxy Report Score

  The PROMIS Pediatric Short Form Pain Behaviors, Parent-Proxy Report is an 8-item measure completed by parents that assesses pain behaviors displayed by their child in the past 7 days. Total scores are standardized to a T-score with a mean of 50 and a standard deviation of 10, where higher scores indicate increased behaviors due to pain.

  Baseline, Immediately Post-Treatment, Month 3, Month 6

• Child Self-Efficacy Scale Score

  Child Self-Efficacy Scale, Self- and Parent-Proxy Report is a well-established, 7-item measure of self-efficacy for functioning despite pain for 8-19 year olds. Respondents report how sure about their (or their child's) ability to perform certain daily tasks when they have pain, on a scale from 1 to 5 where 1 = very sure and 5 = very unsure. Total scores range from 7 to 35 and lower scores indicate greater self-efficacy.

  Baseline, Immediately Post-Treatment, Month 3, Month 6

• Number of Dyads Completing the Study

  Treatment feasibility was assessed by the number of participant dyads who complete the study.

  Month 6

• Number of Dyads Completing Study Assignments Within Six Months

  Treatment feasibility was assessed by the number of dyads completing the 6-Month study assignment.

  Month 6

• Number of Participants With Positive Experiences During Participant Evaluation of the Intervention Interview

  Treatment feasibility was assessed via a qualitative interview where participants were asked open ended questions. Participants were asked if they thought the Back2Life program helpful, if delivering the program through telemedicine was reasonable, and if the program was a reasonable approach for chronic pain management of sickle cell disease.

  Immediately Post-Treatment

• Treatment Evaluation Inventory-Short Form (TEI-SF) Score

  The Treatment Evaluation Inventory-Short Form was completed at the end of treatment. It includes 9 items adapted to be specific to pediatric pain. Items are rated on a 5-point Likert scale ranging from 1 to 5. Total scores range from 9 to 45. Higher scores indicate increased acceptability with the study treatment.

  Immediately Post-Treatment

Secondary Outcomes (15)

• Emergency Department Visits Per Participant

  12 months prior to Baseline, 12 months post-treatment

• Hospital Admissions Per Participant

  12 months prior to Baseline, 12 months post-treatment

• Days Per Week of Opioid Use

  Baseline, Immediately Post-Treatment, Month 3, Month 6

• Pediatric Inventory for Parents (PIP) Score

  Baseline, Immediately Post-Treatment, Month 3, Month 6

• Adolescent Sleep Wake Scale (ASWS) Score

  Baseline, Immediately Post-Treatment, Month 3, Month 6

Study Arms (1)

Back2Life Program

EXPERIMENTAL

Youth with chronic SCD pain and their parents or caregivers receiving an adaptive cognitive behavioral treatment program for pain coping skills.

Behavioral: Back2Life

Interventions

Back2Life BEHAVIORAL

The Back2Life intervention uses an adaptive treatment approach with module-based treatment sessions selected on the basis of baseline assessment (rather than a fixed treatment approach) to allow flexibility in tailoring treatment components to meet individual family needs. All youth participants will receive the standard 6-session pain coping skills training program, consisting of learning ways to cope with and manage chronic sickle cell pain. The standard program includes topics that were identified by young people with chronic sickle cell pain and their parents as important skills for all youth with chronic pain and sickle cell disease. In addition to the standard 6-session program, youth participants may receive an additional 1 to 4 sessions that may help with specific problems and/or co-morbidities related to pain. At least one parent or guardian is required to attend the sessions with their child.

Back2Life Program

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• diagnosed with SCD (any genotype)
• report chronic pain
• speak and read English
• have not initiated new disease modifying-treatments (e.g, hydroxyurea, Endari, voxelotor, crizanlizumab, chronic transfusions) or significantly increased dosages of any disease-modifying treatments in the past 3 months
• speak and read English

You may not qualify if:

• have comorbid medical conditions typically associated with pain but unrelated to SCD (e.g., rheumatologic disorders or inflammatory bowel disease)
• are receiving chronic transfusion indicated for central nervous system risks and/or complications, previous overt strokes, or significant cognitive or developmental limitations, as per their healthcare provider or parent, that would impair completion of self-report measures or engagement in treatment sessions
• received ≥ 3 sessions of outpatient psychological therapy for pain management in the 6 months prior to screening
• have significant cognitive limitations or severe psychiatric conditions, as per the child's healthcare team or history, that would impair completion of self-report measures or engagement in treatment sessions

Sponsors & Collaborators

• Emory University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Children's Healthcare of Atlanta at Hughes Spalding

Atlanta, Georgia, 30303, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Emory Children's Center

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Soumitri Sil, PhD
• Organization: Emory University

soumitri.sil@emory.edu

404-727-2712

Study Officials

• Soumitri Sil, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Youth and parent/caregiver dyads will participate in the same intervention.

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: January 27, 2021
• Primary Completion: August 23, 2023
• Study Completion: May 18, 2024
• Last Updated: June 29, 2025
• Results First Posted: December 13, 2024

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)