Training program to help teens with sickle cell pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research evaluates the I-STRONG program, which combines mind-body, cognitive-behavioral, and neuromuscular movement training to assist adolescents with chronic sickle cell disease pain. The program consists of 16 group-based telehealth sessions over 8 weeks, aimed at improving everyday functioning and reducing pain symptoms. Participants will be randomly assigned to either start the program immediately or receive enhanced usual care before starting the program later. The study will assess the effectiveness of this intervention compared to standard care alone over a 3-month follow-up period.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Soumitri Sil, PhD, ABPP — Emory University
• Study coordinator: Soumitri Sil, PhD, ABPP
• Email: sil@emory.edu
• Phone: 404-727-2712

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cerebrovascular Reactivity Testing with HD-DOT in Sickle Cell Patients

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• Adapting and testing PEN-Plus in Zambian primary care

  Aiming to see if the PEN-Plus package can be adapted and used in two Zambian hospitals to better manage chronic diseases like heart disease, diabetes, hypertension, and sickle cell in primary care.

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• Newborn Sickle Cell Screening in Mozambique

  We’re testing a three-part plan to help babies in Mozambique get diagnosed early for sickle cell disease and start care quickly.

  Recruiting St. Jude Children's Research Hospital · Nhamatanda, Sofala · NCT07719972

• Optimizing Hydroxyurea in Children with Sickle Cell in Africa

  This study tests whether raising hydroxyurea to a maximum tolerated dose is safe and beneficial for Ugandan children with sickle cell anemia already taking a fixed daily dose.

  Recruiting Phase 1/2 Children's Hospital Medical Center, Cincinnati · Kampala · NCT07708714

• Hematopoietic stem cell editing to treat sickle cell disease

  This study tests whether a patient’s own blood stem cells can be edited to remove the sickle cell triggering gene and then returned to the patient.

  Recruiting Phase 1 Boston Children's Hospital · Boston, Massachusetts · NCT07708350

• Virtual reality options to help with VOC pain in adults with SCD

  This study tests whether headset-based virtual reality can help reduce pain for adults with sickle cell disease during vaso-occlusive crises treated in an infusion center.

  Recruiting University of Maryland, Baltimore · Baltimore, Maryland · NCT07674277

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.