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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Provision of signed and dated willing to sign a consent form form for adolescents 18 years old and caregivers' participation - For children \<18, informed assent and parental willing to sign a consent form to participate in the study - Willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study - Males and females; Ages 12-18 years for adolescents; no age limitations for caregivers - Documented diagnosis of sickle cell disease (any genotype) for adolescents - Adolescent scores at least 3 on the Pediatric Pain Screening Tool - Adolescent reports typical pain intensity in the past week at least 4 on a 0-10 cm Visual Analog Scale - Adolescent on stable disease-modifying treatments, if applicable (e.g., hydroxyurea, glutamine, voxelotor, crizanlizumab) as defined by not newly initiated or significantly increased dosages (mg/kg) in the past 3 months - Speak and read English Who Should NOT Join This Trial: - An adolescent has comorbid medical conditions typically associated with pain but unrelated to SCD (e.g., rheumatologic disorders or inflammatory bowel disease) - Adolescent has undergone genetic or hematopoietic stem cell therapy - Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation - Adolescents receiving active treatment (e.g., weekly appointments with a provider) for nonpharmacological therapies (e.g., structured behavioral pain management, physical therapy, or acupuncture program) that overlap with the active phase of the study intervention Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Provision of signed and dated informed consent form for adolescents 18 years old and caregivers' participation * For children \<18, informed assent and parental informed consent to participate in the study * Willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study * Males and females; Ages 12-18 years for adolescents; no age limitations for caregivers * Documented diagnosis of sickle cell disease (any genotype) for adolescents * Adolescent scores at least 3 on the Pediatric Pain Screening Tool * Adolescent reports typical pain intensity in the past week at least 4 on a 0-10 cm Visual Analog Scale * Adolescent on stable disease-modifying treatments, if applicable (e.g., hydroxyurea, glutamine, voxelotor, crizanlizumab) as defined by not newly initiated or significantly increased dosages (mg/kg) in the past 3 months * Speak and read English Exclusion Criteria: * An adolescent has comorbid medical conditions typically associated with pain but unrelated to SCD (e.g., rheumatologic disorders or inflammatory bowel disease) * Adolescent has undergone genetic or hematopoietic stem cell therapy * Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation * Adolescents receiving active treatment (e.g., weekly appointments with a provider) for nonpharmacological therapies (e.g., structured behavioral pain management, physical therapy, or acupuncture program) that overlap with the active phase of the study intervention

Treatments Being Tested

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.

Locations (4)

Connecticut Children's Medical Center
Hartford, Connecticut, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Arthur M. Blank Hospital | Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States