Who is eligible for clinical trial NCT06691867?

Participants must meet protocol criteria for Sickle Cell Disease. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06691867 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-11-12

Integrative Training Program for Pediatric Sickle Cell Pain (NCT06691867)

🟢 Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: Emory University

🩺 Plain-English Summary (8th-Grade Level)

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 can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (5 items).

Location: Connecticut Children's Medical Center — Hartford, Connecticut

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (4 Sites)

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗