NCT06691867 Integrative Training Program for Pediatric Sickle Cell Pain
| NCT ID | NCT06691867 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Sickle Cell Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 155 participants |
| Start Date | 2025-01-08 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 155 participants in total. It began in 2025-01-08 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Soumitri Sil, PhD, ABPP
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT06691867 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Sickle Cell Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06691867 currently recruiting?
Yes, NCT06691867 is actively recruiting participants. Contact the research team at sil@emory.edu for enrollment information.
Where is the NCT06691867 trial being conducted?
This trial is being conducted at Hartford, United States, Atlanta, United States, Atlanta, United States, Cincinnati, United States.
Who is sponsoring the NCT06691867 clinical trial?
NCT06691867 is sponsored by Emory University. The principal investigator is Soumitri Sil, PhD, ABPP at Emory University. The trial plans to enroll 155 participants.
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