Resilience support for adolescents and young adults with sickle cell disease
Promoting Resilience Among Adolescents and Young Adults With Sickle Cell Disease
NA · Boston Children's Hospital · NCT06555939
This project will test a resilience-building program (PRISM) delivered through a collaborative care model for adolescents and young adults with sickle cell disease to see if it is feasible and acceptable.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 8 Years to 25 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06555939 on ClinicalTrials.gov |
What this trial studies
This pilot enrolls 25 adolescents and young adults (ages 8–25) with sickle cell disease who receive care at the Dana-Farber/Boston Children's Hospital blood disorders clinic to receive the PRISM resilience intervention within a Collaborative Care Model. The primary aim is feasibility, defined in part by enrollment greater than 50%, with secondary measures of acceptability and patient satisfaction. Exploratory outcomes include changes in depression, anxiety, and pain interference measured by standard patient-reported instruments. Sessions and surveys are offered in English or Spanish and require cognitive ability to participate and complete questionnaires.
Who should consider this trial
Good fit: Ideal candidates are English- or Spanish-speaking patients aged 8–25 with sickle cell disease who receive care at the DFCI/BCH Blood Disorders Center and score above 9 on the PHQ-9 or a GAD measure, and who are cognitively able to participate.
Not a fit: Patients outside the 8–25 age range, those not receiving care at the DFCI/BCH clinic, non–English/Spanish speakers, or those with cognitive limitations that preclude participation are unlikely to benefit from this pilot.
Why it matters
Potential benefit: If successful, the program could improve coping, reduce depression and anxiety symptoms, and lower pain-related interference for young people with sickle cell disease.
How similar studies have performed: PRISM and comparable resilience interventions have shown feasibility and acceptability in oncology populations, but applying this collaborative-care delivery approach to sickle cell disease is largely novel and under-tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged ≥ 8 and ≤ 25 years of age at baseline * Diagnosed with Sickle Cell Disease (HbSS, HbSC, HbS-Beta Thalassemia, and other related hemoglobinopathies) * Receiving Medical Care at the DFCI/BCH Blood Disorders Center. * Scored \> 9 on Patient Health Questionnaire 9-item (PHQ-9) or Generalized Anxiety Disorder (GAD) * Able to speak English or Spanish language (for PRISM sessions) * Able to read English or Spanish language (for completion of surveys) * Cognitively able to participate in PRISM sessions and complete written questionnaires and surveys, as judged by the site investigator * Willing and able to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: \* does not meet above criteria
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Abby Rosenberg, MD
- Email: abbyr_rosenberg@dfci.harvard.edu
- Phone: 617.632.5286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sickle Cell Disease, adolescents, young adults, resilience, sickle cell disease, collaborative care