Clinical trial NCT06555939: Promoting Resilience Among Adolescents and Young Adults With Sickle Cell Disease
Official title: Promoting Resilience Among Adolescents and Young Adults With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sickle Cell Disease
Keywords: adolescents
young adults
resilience
sickle cell disease
collaborative care
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-08-15
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Enrollment rate (feasibility)
timeFrame: 3-months
Secondary outcomes:
measure: Acceptability
timeFrame: 3-months post-enrollment
Other outcomes:
measure: Patient-Health Questionnaire (PHQ-9)
timeFrame: 3-months
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: 3-months
Locations:
Study officials:
References: