Recruiting

Integrative Training

Sponsor:

Emory University

Code:

NCT06691867

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

I-STRONG

Enhanced Usual Care (EUC)

Study Details

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

Study ID

NCT06691867

Start date

Jan 8, 2025

Status verified date

Nov, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

155 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

Primary outcome measure

  • Brief Pain Inventory (BPI) Pain severity [ Time Frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention ]

Central Contacts and Locations

Central contacts

Soumitri Sil, PhD, ABPP

404-727-2712sil@emory.edu

Locations

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30322

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

Recruiting

Atlanta, Georgia, United States, 30329

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

More Information

Sponsor

Emory University

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-11-14.