Development and Adaptation of I-STRONG for SCD
Part of paid clinical trials in Atlanta, Georgia.
- Sponsor
- Emory University
- Study ID
- NCT06110754
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- I-STRONG for SCD — BEHAVIORALI-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend every session and parents attend 6 of the 16 sessions.
Study Details
This study develops and tests the feasibility and acceptability of an adapted intervention, Integrative Strong Body and Mind Training (I-STRONG), in adolescents with pain from sickle cell disease.
Key Dates
- Start date
- Jun 8, 2023
- Status verified
- Dec 2025
- Primary completion
- Jun 14, 2024
- Completion
- Jun 14, 2024
Study Design
- Enrollment
- 45 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- No Intervention: Development of I-STRONG for SCDAdolescents with sickle cell disease and their parents participating completing in-depth interviews over two sessions as part of adapting an integrative, multicomponent, behavioral intervention combining mind-body, cognitive, and behavioral coping skills with neuromuscular exercise training for adolescents with chronic SCD pain.
- Experimental: I-STRONG for SCDAdolescents with sickle cell disease and their parents participating in a multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training.
Primary Outcome Measure
Brief Pain Inventory (BPI) Pain Severity Score [ Time Frame: Baseline, Post-treatment (Week 8), 3 Months Post-treatment (Month 5) ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Healthcare of Atlanta (CHOA) | Atlanta | Georgia | 30322 | - |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | - |
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