New telehealth program aims to ease sickle cell pain in teens
NCT ID NCT06691867
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a group telehealth program called I-STRONG for teens with sickle cell disease who have chronic pain. The program combines mind-body skills with movement training to help teens cope better and reduce fear of pain. Researchers will enroll 155 teens aged 12-18 to see if the program improves daily functioning and pain symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- I-STRONG behavioral program (mind-body and movement training via telehealth)
- What this could lead to
- If it works, this program could offer teens with sickle cell disease a practical way to manage chronic pain and improve daily functioning without medication.
- What could go wrong
- This is a relatively small, early-stage behavioral trial, so results may not apply to all patients. The program requires commitment to 16 sessions, and benefits may vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 155 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Arthur M. Blank Hospital | Children's Healthcare of Atlanta
RECRUITINGAtlanta, Georgia, 30329, United States
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Children's Healthcare of Atlanta
RECRUITINGAtlanta, Georgia, 30322, United States
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Cincinnati Children's Hospital Medical Center
RECRUITINGCincinnati, Ohio, 45229, United States
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Connecticut Children's Medical Center
RECRUITINGHartford, Connecticut, 06106, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Nonmyeloablative allogeneic peripheral blood mobilized hematopoietic precursor cell transplantation for severe congenital anemias including sickle cell disease (SCD) and B-Thalassemia
- Can an antioxidant supplement calm sickle cell blood cells?
- Can a softer transplant cure sickle cell disease?
- Mindfulness on your phone: a new test for sickle cell pain and sleep
- Urine and MRI: a new hope for spotting silent kidney injury in sickle cell kids?
- Can a home program help kids with sickle cell hit milestones?