RecruitingNot ApplicableNCT06691867

Integrative Training Program for Pediatric Sickle Cell Pain

Integrative Strong Body and Mind Training for Pediatric Sickle Cell Pain (I-STRONG for SCD): Multi-site, Randomized Clinical Trial

Sponsor

Emory University

Enrollment

155 participants

Start Date

Jan 8, 2025

Study Type

INTERVENTIONAL

Conditions

Sickle Cell Disease

Summary

This research aims to answer the question: does a group training program specifically for teens with chronic sickle cell disease (SCD) pain that teaches skills to strengthen the mind and body help improve everyday functioning and reduce pain symptoms? The program will be tailored to address challenges related to frequent or chronic sickle cell pain and may improve participants' physical and emotional health. The program, called I-STRONG for SCD (Integrative Strong Body and Mind Training for Sickle Cell Disease), may help improve everyday functioning and pain symptoms in teens with chronic pain related to SCD. The research team aims to determine how participants (teens and parents) respond to this program.

Eligibility

Min Age: 12 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an integrative training programme for teenagers with sickle cell disease who experience significant ongoing pain. The programme combines pain education, mind-body techniques, and physical activity strategies to help young people manage sickle cell-related pain more effectively. **You may be eligible if...** - You are between 12 and 18 years old - You have been diagnosed with sickle cell disease (any genetic type) - You regularly experience significant pain (pain intensity of 4 or above out of 10 in the past week) - You are on stable sickle cell disease treatments, if applicable - A caregiver is willing to participate alongside you **You may NOT be eligible if...** - Your pain is not at the required level of severity - You are currently in an acute pain crisis requiring hospitalisation - Your caregiver is unable to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALI-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.

OTHEREnhanced 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.