Promoting Resilience Among Adolescents and Young Adults With Sickle Cell Disease

Adolescents and young adults with sickle cell disease (SCD) face challenges managing their illness and maintaining their well-being. This study proposes to test the feasibility and acceptability of a resilience-promoting intervention through a Collaborative Care Model. The primary goal is to determine with the resilience intervention (PRISM) is feasible and acceptable for adolescents and young adults with SCD. Exploratory outcomes include whether this intervention improves depression, anxiety, and pain interference.

Study Overview

• Status: Recruiting
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Behavioral: Collaborative Care Model; Behavioral: Promoting Resilience in Stress Management

Detailed Description

Adolescents and Young Adults (AYAs) with blood disorders are at risk for poor physical, psychological, and social outcomes. Sickle Cell Disease (SCD) is a life-limiting condition, defined as a group of inherited red blood cell disorders disproportionally affecting non-Hispanic Black, African American, and Hispanic/Latino groups. AYAs with SCD experience racial bias, disease-related stigma, and under-treated symptoms, all of which translate to additional challenges managing their illness and maintaining their well-being. This study proposes to address the gaps of mental health support for youth with SCD through delivery of a resilience-promoting intervention (PRISM) using a Collaborative Care Model (CoCM). The primary objective of this study is to test the feasibility and acceptability of a collaborative care model to sustainably deliver the PRISM intervention for AYAs with SCD. Leveraging successful strategies implemented for patients with cancer, we will pilot-test this approach with N=25 AYAs in the Dana-Farber Cancer Institute/Boston Children's hospital (DFCI/BCH) SCD clinic. The primary outcome of interest is feasibility, defined as >50% enrollment. Secondary outcomes include patient reported outcomes of feasibility, acceptability, and satisfaction. Exploratory outcomes include assessment of depression, anxiety, and pain interference. We hypothesize this will be feasible and acceptable in this patient population.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abby Rosenberg, MD; Phone Number: 617.632.5286; Email: abbyr_rosenberg@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CoCM+PRISM; Collaborative Care Model (CoCM) includes a care manager, a defined population of patents/registry for tracking inclusion and progress, validated patient-reported outcome measures, and weekly inter-professional team meetings. This arm includes the use of an inter professional team to triage, plan and deliver care. the PRISM intervention, a brief, skills-based program targeting 4 resilience resources, will be delivered 1:1 as part of this treatment arm.

Behavioral: Collaborative Care Model; The interprofessional team will meet weekly to review survey scores, endorsed psychological and physical health needs, as well as other concerns. They will conduct assessments as a group that may include referrals for additional support.; Behavioral: Promoting Resilience in Stress Management; PRISM targets 4 resilience resources: stress management, goal-setting, cognitive reframing and meaning-making. It is delivered one-on-one by trained coaches in English or Spanish via HIPAA compliant video-conference or in-person. Sessions are delivered every 1-2 weeks based on patient preference. To facilitate practice between sessions, all participants 13 or older have access to the digital PRISM app.; Other Names: PRISM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rate (feasibility)	feasibility assessed by >50% enrollment rate	3-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	program usefulness and willingness to recommend it (assessed via qualitative interviews)	3-months post-enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Health Questionnaire (PHQ-9)	depressive symptoms, range 0-27 with higher scores indicating higher symptoms	3-months
Generalized Anxiety Disorder (GAD-7)	anxiety symptoms, range 0-21 with higher scores indicating higher symptoms	3-months

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: adolescents; young adults; sickle cell disease; resilience; collaborative care
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Anemia, Sickle Cell
• Other Study ID Numbers: IRB-P00048890

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all deidentified IPD that underlie results in a publication
• IPD Sharing Time Frame: 6-months after manuscript is published
• IPD Sharing Access Criteria: contact PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No