NCT06691867Recruiting
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
Source: ClinicalTrials.gov · Last updated 14 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 155 (estimated)
- First submitted
- 13 Nov 2024
- Start date
- 8 Jan 2025
- Primary completion date
- Aug 2027
- Lead sponsor
- Emory University
- Diseases
- Sickle cell disease
- NCT number
- NCT06691867
What you commit to
- Study type: Interventional
- Planned participants: 155
- From 8 Jan 2025 to the primary completion date, Aug 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Adolescent has undergone genetic or hematopoietic stem cell therapy
- 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
Other illness
- An adolescent has comorbid medical conditions typically associated with pain but unrelated to SCD (e.g., rheumatologic disorders or inflammatory bowel disease)
- Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation
Who the study is looking for
- 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
Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arthur M Blank Hospital - Children's Healthcare of Atlanta Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Children's Healthcare of Atlanta Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Connecticut Children's Medical Center Coordinator of this site? Confirm its status | Hartford | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.