Sickle Cell DiseaseNCT06555939
Promoting Resilience Among Adolescents and Young Adults With Sickle Cell Disease
A study testing Collaborative Care Model and Promoting Resilience in Stress Management in people with Sickle Cell Disease, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Collaborative Care Model and Promoting Resilience in Stress Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2025to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- does not meet above criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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
- Being tested
- Collaborative Care Model, Promoting Resilience in Stress Management
- Keywords
- adolescents, young adults, resilience, sickle cell disease, collaborative care
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Care ModelBehavioural
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 ManagementBehavioural
Also called PRISM
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Collaborative Care Model; Behavioral: Promoting Resilience in Stress Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate (feasibility)
feasibility assessed by >50% enrollment rate
Measured: 3-months
Secondary outcomes (1)
Acceptability
program usefulness and willingness to recommend it (assessed via qualitative interviews)
Measured: 3-months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start23 Oct 2025
- Primary completionSep 2029 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Abby Rosenberg, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555939
- Sponsor's protocol ID
- IRB-P00048890
- Status last verified
- Apr 2026
- First submitted
- 13 Aug 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all deidentified IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Resilience Among Adolescents and Young Adults With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT06555939
- Acronym / sponsor ID
- IRB-P00048890
- Conditions
- Sickle Cell Disease
- Keywords
- adolescents, young adults, resilience, sickle cell disease, collaborative care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoCM+PRISM | Experimental | Behavioral: Collaborative Care Model, Behavioral: Promoting Resilience in Stress ManagementCollaborative 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. |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (1 listed)
- does not meet above criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative Care ModelThe 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. | Behavioural | CoCM+PRISM |
| Promoting Resilience in Stress ManagementAlso: PRISMPRISM 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. | Behavioural | CoCM+PRISM |
Primary outcome
Enrollment rate (feasibility)
Time frame: 3-months
feasibility assessed by >50% enrollment rate
1 secondary outcome
Acceptability
Time frame: 3-months post-enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. all deidentified IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Care Model and Promoting Resilience in Stress Management in people with Sickle Cell Disease, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abby Rosenberg, MD (617.632.5286, abbyr_rosenberg@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (feasibility) (time frame: 3-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.