Recruiting

PRISM

Sponsor:

Boston Children's Hospital

Code:

NCT06555939

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 8 - 25

Healthy Volunteers: Not accepted

Interventions

Collaborative Care Model

Promoting Resilience in Stress Management

Study Details

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

Study ID

NCT06555939

Start date

Oct 23, 2025

Status verified date

Apr, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

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.

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.

Primary outcome measure

  • Enrollment rate (feasibility) [ Time Frame: 3-months ]

Central Contacts and Locations

Central contacts

Abby Rosenberg, MD

617.632.5286abbyr_rosenberg@dfci.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Boston Children's Hospital

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-05-05.