Sickle Cell Disease study: I-STRONG
Official title Integrative Training Program for Pediatric Sickle Cell Pain
ClinicalTrials.gov ID: NCT06691867
What this study is testing
- What it's testing
- The study wants to see if the program can improve daily functioning and lower pain for teens with sickle cell disease.
- Who it's for
- Teens who have chronic pain from sickle cell disease and their parents.
- What's involved
- Participants will join a group training program that teaches skills to strengthen mind and body, with sessions for both teens and parents.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 18
You may be able to join if
- 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
You likely can't join if
- An adolescent has comorbid medical conditions typically associated with pain but unrelated to SCD (e.g., rheumatologic disorders or inflammatory...
- 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...
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Hartford, Connecticut, United States
- Atlanta, Georgia, United States
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hartford, Connecticut, United States; Atlanta, Georgia, United States; Cincinnati, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.