Promoting Resilience Among Adolescents and Young Adults With Sickle Cell Disease

NCT06555939 | Recruiting DMC

• 1 other identifier: IRB-P00048890
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

adolescents; young adults; resilience; sickle cell disease; collaborative care

Outcome Measures

Primary Outcomes (1)

• Enrollment rate (feasibility)

  feasibility assessed by \>50% enrollment rate

  3-months

Secondary Outcomes (1)

• Acceptability

  3-months post-enrollment

Other Outcomes (2)

• Patient-Health Questionnaire (PHQ-9)

  3-months

• Generalized Anxiety Disorder (GAD-7)

  3-months

Study Arms (1)

CoCM+PRISM

EXPERIMENTAL

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; Behavioral: Promoting Resilience in Stress Management

Interventions

Collaborative Care Model 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.

CoCM+PRISM

Promoting Resilience in Stress Management 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.

Also known as: PRISM

CoCM+PRISM

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \* does not meet above criteria

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Abby Rosenberg, MD

CONTACT

617.632.5286; abbyr_rosenberg@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Pediatric Palliative Care

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: October 23, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2030
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6-months after manuscript is published
• Access Criteria: contact PI

Locations

US (1)