Promoting Resilience Among Adolescents and Young Adults With Sickle Cell Disease

ConditionSickle Cell Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age8-25

SponsorBoston Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

25 Participants

are divided into 1 treatment group

Group A: CoCM+PRISMExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Enrollment rate (feasibility)

feasibility assessed by \>50% enrollment rate

Time frame

3-months

Secondary outcomes

Acceptability

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

Time frame

3-months post-enrollment

Other outcomes

Patient-Health Questionnaire (PHQ-9)

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

Time frame

3-months

Generalized Anxiety Disorder (GAD-7)

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

Time frame

3-months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Children's Hospital

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov

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