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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 9 months, 8 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will last approximately 36 months, with participant involvement lasting 9 months."
  • "In addition to usual care, participants will receive the I-STRONG intervention, which consists of 16 group-based telehealth sessions (90 minutes each), held twice weekly for 8 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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

Study sites (4)

CT

GA

OH