Promoting Resilience Among Adolescents and Young Adults With Sickle Cell Disease

NCT ID: NCT06555939

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-23
• Study Completion Date: 2030-09-30

Brief Summary

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.

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.

Conditions

Sickle Cell Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Collaborative Care Model

Intervention Type: BEHAVIORAL

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.

Promoting Resilience in Stress Management

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

PRISM

Eligibility Criteria

Inclusion Criteria

• Aged ≥ 12 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Abby Rosenberg

Chief, Pediatric Palliative Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Abby Rosenberg, MD

Role: CONTACT

abbyr_rosenberg@dfci.harvard.edu

617.632.5286

Other Identifiers

IRB-P00048890

Identifier Type: -

Identifier Source: org_study_id