Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06555939

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

8 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: PRISM

Primary outcomes

  1. Enrollment rate (feasibility)

    Time frame: 3-months

    feasibility assessed by >50% enrollment rate

Secondary outcomes

  1. Acceptability

    Time frame: 3-months post-enrollment

    program usefulness and willingness to recommend it (assessed via qualitative interviews)

Other outcomes

  1. Patient-Health Questionnaire (PHQ-9)

    Time frame: 3-months

    depressive symptoms, range 0-27 with higher scores indicating higher symptoms

  2. Generalized Anxiety Disorder (GAD-7)

    Time frame: 3-months

    anxiety symptoms, range 0-21 with higher scores indicating higher symptoms

Study contacts

Contact information is provided by the study sponsor or research team.

Abby Rosenberg, MD

CONTACT

[email protected]

617.632.5286

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Aug 15, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.