The project will test a tailored web and smartphone-based application (iCanCope with SCD) to improve pain self-management and functioning in youth (aged 12-18) with sickle cell disease. The program will include goal setting, peer-based social support, and pain self-management training. The investigators will determine initial program effectiveness through a pilot three-site randomized controlled trial in 160 youth randomized to treatment compared to attention control.
Cognitive-behavioral therapies (CBT) that promote pain self-management can lead to symptom reduction, improved quality of life, and decreased healthcare use. However, most people with SCD do not receive CBT-based treatment due to barriers such as poor accessibility, limited availability of professionals, and high costs. First, the investigators plan to apply a user-centered design approach to develop and refine the iCanCope with SCD program. Second, program feasibility and initial program effectiveness will be determined through a pilot three-site randomized controlled trial. The investigators will determine study accrual and dropout rates as well as levels of patient acceptability and engagement. Preliminary effectiveness will be determined in youth receiving treatment compared to attention control on a range of physical, behavioral, and psychosocial outcomes assessed at post-treatment and 6-month follow-up. Third, moderators and mediators of treatment effect will be tested by examining whether differences in self-efficacy and patient activation predict changes in pain and functioning. These results will enable a future full-scale randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
137
The program is designed to enhance self-efficacy. The app will guide youth in setting structured and personalized goals aimed at improving their pain and functioning. The pain self-management skills will include personalized CBT-based coping skills including deep breathing, relaxation, and cognitive skills (e.g., staying positive). The app will provide in-the-moment access to pain coping strategies to promote positive changes in mood, behavior, and pain.
Education about sickle cell disease to increase disease knowledge
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Emory University
Atlanta, Georgia, United States
Seattle Children's Hospital
Seattle, Washington, United States
The Hospital for Sick Children
Toronto, Ontario, Canada
Pain Diary - Average Daily Pain
App diary using an 11-point numerical rating scale for pain intensity for 7 days Scores range from 0-10 where higher scores indicate a worse outcome
Time frame: Baseline,12 weeks, and 26 weeks
Pain Diary - Average Daily Activity Limitations
App diary using Child Activity Limitations Inventory 9-items to measure activity limitations for 7 days Scores range from 0-100 where higher scores mean a worse outcome
Time frame: Baseline,12 weeks, and 26 weeks
Adaptive Coping - Coping Attempts
Coping Strategies Questionnaire for Sickle Cell Disease - Coping Attempts Factor Scores range from 0 - 180, higher scores mean a better outcome
Time frame: Baseline,12 weeks, and 26 weeks
Treatment Acceptability
Treatment Evaluation Inventory scores range from 9 - 45 where higher scores mean a better outcome
Time frame: 2 months after starting treatment
Physical and Emotional Functioning - Depressive Symptoms
Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Depressive Symptoms T-score, higher scores means higher depressive symptoms. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of depressive symptoms.
Time frame: Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Anxiety
Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Anxiety T-score, higher scores means higher levels of anxiety. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of anxiety.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Mobility
Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Mobility T-score, higher scores means better mobility. 50 indicates the population mean with a standard deviation of 10. A T-score of 40 is indicative of sub-clinical mobility limitations.
Time frame: Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Pain Interference
Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Pain Interference T-score, higher scores means more pain interference. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of pain interference.
Time frame: Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Fatigue
Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Fatigue T-score, higher scores means higher levels of fatigue. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of fatigue.
Time frame: Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Peer Relationships
Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Peer Relationships T-score, higher scores means better peer relationships. 50 indicates the population mean with a standard deviation of 10. A T-score of 40 is indicative of sub-clinical or reduced quality of peer relationships.
Time frame: Baseline,12 weeks, and 26 weeks
Patient Global Impression of Change
Global rating for improvement in pain and functioning Scores range from 1-7 where higher scores mean a better outcome
Time frame: 12 weeks and 26 weeks
Parent Protectiveness
Adult Responses to Children's Symptoms Scores range from 0-4 where higher scores mean a worse outcome
Time frame: Baseline,12 weeks, and 26 weeks
Health Services Utilization
Client Services Receipt Inventory adapted for sickle cell disease - Number of hospitalizations and/or ED visits
Time frame: Baseline and 26 weeks
Parent Psychological Distress
Symptom Checklist 90 - Global Severity Index Scores range from 0-4, with higher scores indicating a worse outcome
Time frame: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Social Functioning
Bath Adolescent Pain Questionnaire - Parent version, Social Functioning (score range: 0-36). A higher score indicates more impaired functioning for all subscales.
Time frame: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Physical Functioning
Bath Adolescent Pain Questionnaire - Parent version Physical Functioning (0-36). A higher score indicates more impaired functioning for all subscales.
Time frame: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Depression
Bath Adolescent Pain Questionnaire - Parent version, Depression (0-24). A higher score indicates more impaired functioning for all subscales.
Time frame: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, General Anxiety
Bath Adolescent Pain Questionnaire - Parent version, General Anxiety (0-28). A higher score indicates more impaired functioning for all subscales.
Time frame: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety
Bath Adolescent Pain Questionnaire - Parent version, Pain Specific Anxiety (0-28). A higher score indicates more impaired functioning for all subscales.
Time frame: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Family Functioning
Bath Adolescent Pain Questionnaire - Parent, Family Functioning (0-48). A higher score indicates more impaired functioning for all subscales.
Time frame: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Development
Bath Adolescent Pain Questionnaire - Parent version, Development (0-44). A higher score indicates more impaired functioning for all subscales.
Time frame: Baseline,12 weeks, and 26 weeks
Treatment Experiences - Child
Self report of treatment experiences. The number of participants with high levels of increased stress or anxiety will be reported.
Time frame: 12 weeks and 26 weeks