Trial Outcomes & Findings for Building Adaptive Coping and Knowledge to Improve Daily Life (NCT NCT04602728)

Participants were recruited from Children's Healthcare of Atlanta, Emory Children's Center, and Children's Healthcare of Atlanta at Hughes Spalding in Atlanta, Georgia, USA. Participant enrollment began January 27, 2021. Data collection for the 6 Month time point ended August 23, 2023 and data collection for the 12 Month time point was complete on May 18, 2024.

Building Adaptive Coping and Knowledge to Improve Daily Life

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.

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.

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.

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.

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

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

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.

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.

Healthcare utilization was extracted from the medical record to document the mean number of emergency department (ED) visits for pain per participant during the 12 months preceding the intervention period and the 12-month period post-treatment.

Healthcare utilization was extracted from the medical record to document the mean number of hospital admissions for pain per participant during the 12 months preceding the intervention and the 12-month period post-treatment.

Daily use of opioid pain medication was determined based on participant completion of daily diaries for 1-week at each assessment visit. Participants recorded opioid use daily (presence/absence).

The Pediatric Inventory for Parents is a 42-item parent-reported measure of caregiver stress related to child chronic illness. Responses are given on a 5-point Likert scale where 1 = not at all and 5 = extremely. Total scores range from 42 to 210 and higher scores indicate greater caregiver stress.

The Adolescent Sleep Wake Scale (ASWS) is a 28-item patient-reported describing the occurrence and frequency of various behavioral sleep characteristics over the past month. Responses are given on a 6-point Likert scale where 1 = always and 6 = never. Total scores are calculated as the mean score from each time and range from 1 to 6 where higher scores indicate better sleep quality.

The PROMIS Pediatric Short Form Depressive Symptoms questionnaire, Self- and Parent-Proxy Report is an 8-item measure designed for youth to assess self-reported symptoms of depression. Total scores are standardized to a T-score with a mean of 50 and a standard deviation of 10, where higher scores indicate increased depression.

The Pain Catastrophizing Scale, Child and Parent Report, is a 13-item well-validated self-report and parent-report measure of worried thoughts about pain. Items are answered on a 5-point scale where 0 = not true at all and 4 = very true. Total scores range from 0 to 52 and higher scores indicate increased catastrophic thinking.

The Pain Stages of Change Questionnaire, Adolescent and Parent Report is a 30-item measure designed to evaluate parent and adolescent perceptions of readiness to adopt a self-management approach to pain. Responses are given on a 5-point scale where 1 = strongly disagree and 5 = strongly agree. Average scores are obtained for categories of Pre-contemplation (believing pain management is solely the responsibility of medical professionals), Contemplation (considering using self-management for pain), Action (starts taking ownership of pain control and self-management of pain), and Maintenance (continuous development and self-management of chronic pain); the category with the highest score indicates where the youth participant is in terms of stages of change related to pain management. For this outcome measure, the average scores for the Action scale are reported. Total scores for the Action scale range from 1 to 5 and higher scores indicate increased readiness to self-manage pain.

Plasma concentration of the inflammatory biomarker IL-1β is assessed among youth participants who opted for blood sample collection. IL-1β increases in response to inflammation, pain, and autoimmune diseases.

Plasma concentration of the inflammatory biomarker IL-6 is assessed among youth participants who opted for blood sample collection. IL-6 is increased during injury or illness.

Plasma concentration of the inflammatory biomarker IL-8 is assessed among youth participants who opted for blood sample collection. IL-8 is produced during the presence of inflammation.

Plasma concentration of the inflammatory biomarker TNF-α is assessed among youth participants who opted for blood sample collection. TNF-α is a pro-inflammatory cytokine that regulates the inflammatory response and it is elevated during illness or injury.

Plasma concentration of the inflammatory biomarker CRP is assessed among youth participants who opted for blood sample collection. CRP increases in response to bodily inflammation.

Plasma concentration of the inflammatory biomarker BDNF is assessed among youth participants who opted for blood sample collection. BDNF expression is reduced when high bodily inflammation is present.

Plasma concentration of the inflammatory biomarker IFN-y is assessed among youth participants who opted for blood sample collection. IFN-y is involved with regulating immune and inflammatory responses. IFN-y concentration is elevated during illness.