Integrative Strong Body and Mind Training for Pediatric Sickle Cell Pain (I-STRONG for SCD): Multi-site, Randomized Clinical Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Connecticut
Connecticut Children's Medical Center
NOT_YET_RECRUITING
Hartford
Georgia
Arthur M. Blank Hospital | Children's Healthcare of Atlanta
RECRUITING
Atlanta
Children's Healthcare of Atlanta
NOT_YET_RECRUITING
Atlanta
Ohio
Cincinnati Children's Hospital Medical Center
NOT_YET_RECRUITING
Cincinnati
Contact Information
Primary
Soumitri Sil, PhD, ABPP
sil@emory.edu
404-727-2712
Time Frame
Start Date: 2025-01-08
Estimated Completion Date: 2027-08
Participants
Target number of participants: 155
Treatments
Experimental: I-STRONG - Early Start
Youth and caregivers will receive the I-STRONG for SCD intervention in addition to standard care.
Other: Enhanced Usual Care (EUC)
Participants randomized to EUC will continue with standard care and optimal management of their SCD and chronic pain for approximately 8 months. After completing the 6-month follow-up assessment, participants will have the opportunity to start the I-STRONG SCD intervention.
Sponsors
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Leads: Emory University

This content was sourced from clinicaltrials.gov