Integrative Training Program for Pediatric Sickle Cell Pain

Last updated: January 21, 2025
Sponsor: Emory University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sickle Cell Disease

Red Blood Cell Disorders

Treatment

Enhanced Usual Care (EUC)

I-STRONG

Clinical Study ID

NCT06691867
STUDY00008060
R33AT012421
  • Ages 12-18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Provision of signed and dated informed consent form for adolescents 18 years old andcaregivers' participation

  • For children <18, informed assent and parental informed consent to participate inthe study

  • Willingness to comply with all study procedures and lifestyle considerations andavailability for the duration of the study

  • Males and females; Ages 12-18 years for adolescents; no age limitations forcaregivers

  • 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 cmVisual Analog Scale

  • Adolescent on stable disease-modifying treatments, if applicable (e.g., hydroxyurea,glutamine, voxelotor, crizanlizumab) as defined by not newly initiated orsignificantly increased dosages (mg/kg) in the past 3 months

  • Speak and read English

Exclusion

Exclusion Criteria:

  • An adolescent has comorbid medical conditions typically associated with pain butunrelated 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, orphysical 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 thestudy intervention

Study Design

Total Participants: 155
Treatment Group(s): 2
Primary Treatment: Enhanced Usual Care (EUC)
Phase:
Study Start date:
January 08, 2025
Estimated Completion Date:
August 31, 2027

Study Description

I-STRONG for SCD integrates evidence-based mind-body, cognitive-behavioral, and neuromuscular movement training. It will be tested using an individually randomized group treatment (IRGT) design, comparing early start to the enhanced usual care. The primary objective is to determine whether I-STRONG for SCD combined with standard care is more effective than standard care alone in improving pain intensity from baseline to the 3-month follow-up in adolescents with SCD.

Adolescent participants with sickle cell disease and their caregivers will be recruited for this study. Participants of all genders, races, and ethnicities are eligible, with a majority expected to be Black or African American females, consistent with previous studies of individuals with SCD and chronic pain. The study will last approximately 36 months, with participant involvement lasting 9 months.

I-STRONG for SCD has been adapted based on feedback from patients and caregivers, focusing on chronic SCD pain. In addition to usual care, participants will receive the I-STRONG intervention, which consists of 16 group-based telehealth sessions (90 minutes each), held twice weekly for 8 weeks. All patients can participate in I-STRONG, with randomization determining whether they begin with Early Start (after completing the baseline assessment) or Enhanced Usual Care (approximately 8 months after the baseline assessment).

Connect with a study center

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Arthur M. Blank Hospital | Children's Healthcare of Atlanta

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

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