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 — BEHAVIORAL
    I-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 SCD
    Adolescents 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 SCD
    Adolescents 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)

FacilityCityStateZIPSite coordinators
Children's Healthcare of Atlanta (CHOA)AtlantaGeorgia30322-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-

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