Integrative Training Program for Pediatric Sickle Cell Pain

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.

Conditions

• Sickle Cell Disease

Interventions

BEHAVIORAL

I-STRONG

I-STRONG is an evidence-based protocol from the FIT Teens program. This intervention combines mind-body and cognitive-behavioral approaches with neuromuscular movement training informed by pediatric sports medicine and injury prevention research. It aims to teach mind-body skills applicable during movement training to enhance psychological coping and reduce fear of pain and activity avoidance. I-STRONG consists of 16 group-based telehealth sessions held twice weekly over 8 weeks. Each group can accommodate up to 6 patients with SCD. Adolescents are expected to attend all sessions, while parents will attend 6 of the 16. Parents will receive education about I-STRONG, guidance on supporting their teen's behavior change, and opportunities for networking with other parents of youth with SCD. Sessions will include brief daily homework (e.g., using phone apps to practice skills) to facilitate proficiency. Participants will self-report their practice of assigned skills.

OTHER

Enhanced Usual Care (EUC)

The EUC arm is designed to account for potential effects on time and standard medical care outcomes. Patients randomized to EUC will continue with standard care and optimal management of their SCD and chronic pain for approximately 8 months (i.e., time from enrollment through 6-month post-treatment assessment) before starting the intervention program to coincide with the study duration of the ES arm. After completing the 6-month follow-up assessment, patients will have the opportunity to start the I-STRONG for SCD intervention.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• Emory University

  lead OTHER

Principal Investigators

• Soumitri Sil, PhD, ABPP · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-08

Primary Completion

2027-08-31

Completion

2027-08-31

Countries

• United States

Study Locations