Integrative Training Program for Pediatric Sickle Cell Pain

NCT06691867 | Recruiting DMC

• 3 other identifiers: STUDY00008060R33AT0124212024P007498
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Sickle Cell Pain; Lifestyle considerations; Pediatrics; Behavioral intervention; Mind-body intervention

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory (BPI) Pain severity

  Pain intensity is rated with the pain severity item of the Brief Pain Inventory (BPI). The single item is scored on a scale from 0 to 10 where no pain = 0 and severe pain = 10. This outcome applies to teens only.

  Baseline, immediately post-intervention, 3 months and 6 months post-intervention

Secondary Outcomes (16)

• Change in Brief Pain Inventory (BPI) Pain Interference Score

  Baseline, immediately post-intervention, 3 months and 6 months post-intervention

• Patient Health Questionnaire (PHQ-8) Score

  Baseline, immediately post-intervention, 3 months and 6 months post-intervention

• General Anxiety Disorder (GAD-2)

  Baseline, immediately post-intervention, 3 months and 6 months post-intervention

• Pain Catastrophizing Scale

  Baseline, immediately post-intervention, 3 months and 6 months post-intervention

• Pediatric Quality of Life Inventory (PedsQL) Score

  Baseline, immediately post-intervention, 3 months and 6 months post-intervention

Study Arms (2)

I-STRONG - Early Start

EXPERIMENTAL

Youth and caregivers will receive the I-STRONG for SCD intervention in addition to standard care.

Behavioral: I-STRONG

Enhanced Usual Care (EUC)

OTHER

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.

Other: Enhanced Usual Care (EUC)

Interventions

I-STRONG BEHAVIORAL

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.

Also known as: Intervention Group

I-STRONG - Early Start

Enhanced Usual Care (EUC) OTHER

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.

Also known as: Control Group

Enhanced Usual Care (EUC)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (4)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

RECRUITING

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

RECRUITING

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

Atlanta, Georgia, 30329, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Soumitri Sil, PhD, ABPP

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soumitri Sil, PhD, ABPP

CONTACT

404-727-2712; sil@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 18, 2024
• Study Start: January 8, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available for sharing beginning 9 months and ending 36 months following article publication.
• Access Criteria: Data for sharing will be available in an NIH HEAL-approved data repository for public use.

Locations

US (4)