155
Participants
Start Date
January 8, 2025
Primary Completion Date
August 31, 2027
Study Completion Date
August 31, 2027
I-STRONG
"I-STRONG is an evidence-based protocol from the FIT Teens program. This intervention combines mind-body and cognitive-behavioral approaches with neuromuscular movement training informed by pediatric sports medicine and injury prevention research. It aims to teach mind-body skills applicable during movement training to enhance psychological coping and reduce fear of pain and activity avoidance.~I-STRONG consists of 16 group-based telehealth sessions held twice weekly over 8 weeks. Each group can accommodate up to 6 patients with SCD. Adolescents are expected to attend all sessions, while parents will attend 6 of the 16. Parents will receive education about I-STRONG, guidance on supporting their teen's behavior change, and opportunities for networking with other parents of youth with SCD. Sessions will include brief daily homework (e.g., using phone apps to practice skills) to facilitate proficiency. Participants will self-report their practice of assigned skills."
Enhanced Usual Care (EUC)
The EUC arm is designed to account for potential effects on time and standard medical care outcomes. Patients randomized to EUC will continue with standard care and optimal management of their SCD and chronic pain for approximately 8 months (i.e., time from enrollment through 6-month post-treatment assessment) before starting the intervention program to coincide with the study duration of the ES arm. After completing the 6-month follow-up assessment, patients will have the opportunity to start the I-STRONG for SCD intervention.
NOT_YET_RECRUITING
Children's Healthcare of Atlanta, Atlanta
NOT_YET_RECRUITING
Cincinnati Children's Hospital Medical Center, Cincinnati
NOT_YET_RECRUITING
Connecticut Children's Medical Center, Hartford
RECRUITING
"Arthur M. Blank Hospital , Children's Healthcare of Atlanta"
National Center for Complementary and Integrative Health (NCCIH)
NIH
Emory University
OTHER