Integrative Training Program for Pediatric Sickle Cell Pain

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Emory University
Study ID
NCT06691867
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jan 8, 2025
Status verified
Nov 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
155 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Connecticut Children's Medical CenterHartfordConnecticut06106-
Arthur M. Blank Hospital | Children's Healthcare of AtlantaAtlantaGeorgia30329-
Children's Healthcare of AtlantaAtlantaGeorgia30322-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-

Find similar trials in Hartford, CT

By condition
Sickle cell disease
By research site
Connecticut Children's Medical Center· Hartford, CTArthur M. Blank Hospital | Children's Healthcare of Atlanta· Atlanta, GAChildren's Healthcare of Atlanta· Atlanta, GACincinnati Children's Hospital Medical Center· Cincinnati, OH

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