Integrative Training Program for Pediatric Sickle Cell Pain

Description

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.

Conditions

Sickle Cell Disease

Study Overview

Study Details

Study overview

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.

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

Integrative Training Program for Pediatric Sickle Cell Pain

Condition
Sickle Cell Disease
Intervention / Treatment

-

Contacts and Locations

Hartford

Connecticut Children's Medical Center, Hartford, Connecticut, United States, 06106

Atlanta

Children's Healthcare of Atlanta, Atlanta, Georgia, United States, 30322

Atlanta

Arthur M. Blank Hospital | Children's Healthcare of Atlanta, Atlanta, Georgia, United States, 30329

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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 with the active phase of the study intervention

Ages Eligible for Study

12 Years to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Emory University,

Soumitri Sil, PhD, ABPP, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2027-08