Integrative Training Program for Pediatric Sickle Cell Pain

NARecruitingINTERVENTIONAL
Enrollment

155

Participants

Timeline

Start Date

January 8, 2025

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2027

Conditions
Sickle Cell Disease
Interventions
BEHAVIORAL

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."

OTHER

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.

Trial Locations (4)

30322

NOT_YET_RECRUITING

Children's Healthcare of Atlanta, Atlanta

45229

NOT_YET_RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

06106

NOT_YET_RECRUITING

Connecticut Children's Medical Center, Hartford

Georgia

RECRUITING

"Arthur M. Blank Hospital , Children's Healthcare of Atlanta"

All Listed Sponsors
collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

lead

Emory University

OTHER