Integrative Training Program for Pediatric Sickle Cell Pain

Official title

Integrative Strong Body and Mind Training for Pediatric Sickle Cell Pain (I-STRONG for SCD): Multi-site, Randomized Clinical Trial

Overview

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.

Detailed description

I-STRONG for SCD integrates evidence-based mind-body, cognitive-behavioral, and neuromuscular movement training. It will be tested using an individually randomized group treatment (IRGT) design, comparing early start to the enhanced usual care. The primary objective is to determine whether I-STRONG for SCD combined with standard care is more effective than standard care alone in improving pain intensity from baseline to the 3-month follow-up in adolescents with SCD.

Adolescent participants with sickle cell disease and their caregivers will be recruited for this study. Participants of all genders, races, and ethnicities are eligible, with a majority expected to be Black or African American females, consistent with previous studies of individuals with SCD and chronic pain. The study will last approximately 36 months, with participant involvement lasting 9 months.

I-STRONG for SCD has been adapted from the Fibromyalgia Integrative Training for Teens (FIT Teens) program based on feedback from patients and caregivers, focusing on chronic SCD pain. In addition to usual care, participants will receive the I-STRONG intervention, which consists of 16 group-based telehealth sessions (90 minutes each), held twice weekly for 8 weeks. All patients can participate in I-STRONG, with randomization determining whether they begin with Early Start (after completing the baseline assessment) or Enhanced Usual Care (approximately 8 months after the baseline assessment).

Support from and inclusion in the National Institutes of Health (NIH) Helping to End Addiction Long-term Initiative (HEAL), or NIH HEAL Initiative, is provided for this study. For more information about the initiative visit the HEAL Initiative (https://heal.nih.gov/).

Interventions

• Behavioral 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
• Other 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 t

Primary outcome measures

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

Secondary outcome measures (12)

• Change in Brief Pain Inventory (BPI) Pain Interference Score [Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention]
• Patient Health Questionnaire (PHQ-8) Score [Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention]
• General Anxiety Disorder (GAD-2) [Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention]
• Pain Catastrophizing Scale [Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention]
• Pediatric Quality of Life Inventory (PedsQL) Score [Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention]
• Adolescent Sleep-Wake Scale (ASWS) Score Short Form [Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention]
• National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST) Tool Level 2 score [Time frame: Baseline, 3 months post-intervention]
• Opioid Use [Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention]
• Opioid morphine milligram equivalent Use [Time frame: Baseline and 3 months post-intervention]
• Patient Global Impression of Change (PGIC) Score [Time frame: Baseline, 3 months and 6 months post-intervention]
• Treatment Evaluation Inventory-Short Form (TEI-SF) Score [Time frame: Immediately post-intervention]
• Tampa Scale of Kinesiophobia (TSK) Score [Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 4 centers

• Connecticut Children's Medical Center — Hartford
• Children's Healthcare of Atlanta — Atlanta
• Arthur M. Blank Hospital | Children's Healthcare of Atlanta — Atlanta
• Cincinnati Children's Hospital Medical Center — Cincinnati

Identifiers

NCT: NCT06691867 · STUDY00008060 · R33AT012421 · 2024P007498

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗