Promoting Resilience Among Adolescents and Young Adults With Sickle Cell Disease

Not Applicable

Not yet recruiting

• Conditions: Sickle Cell Disease
• Interventions: Behavioral: Collaborative Care Model; Behavioral: Promoting Resilience in Stress Management

• Registration Number: NCT06555939
• Lead Sponsor: Boston Children's Hospital

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-15
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19
• Study Start: 2024-10
• Primary Completion: 2029-09
• Study Completion: 2030-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CoCM+PRISM	Promoting Resilience in Stress Management	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.
CoCM+PRISM	Collaborative Care Model	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.

Primary Outcome Measures

Name	Time	Method
Enrollment rate (feasibility)	3-months	feasibility assessed by \>50% enrollment rate

Secondary Outcome Measures

Name	Time	Method
Acceptability	3-months post-enrollment	program usefulness and willingness to recommend it (assessed via qualitative interviews)