Writing Relaxing Beats in Adolescents Who Have Sickle Cell Disease

BEHAVIORAL

Songwriting intervention (active music therapy)

Participants will engage in a songwriting intervention with a music therapist.

Change in State-Trait Anxiety Inventory score

Time frame: Baseline, 3 months

The State and Trait Anxiety Inventory measures anxiety. Participants respond to 20 questions about how they are currently feeling on a 4-point Likert scale of 1 (not at all) to 4 (very much so). A total score is calculated by summing the item responses and ranges from 20 to 80. Higher scores indicate higher anxiety (a worse outcome) and lower scores indicate less anxiety (a better outcome).

Change in Patient Health Questionnaire (PHQ-A) score Change in Patient Health Questionnaire for Adolescents (PHQ-A) score

Time frame: Baseline, 3 months

The Patient Health Questionnaire for Adolescents (PHQ-A) is a modified version of the PHQ-9 to be used with adolescents. Participants respond to 9 questions scored on a 4-point Likert scale of 0 (Not at all) to 3 (Nearly every day). A total score is calculated by summing the item responses and ranges from 0 to 27; higher scores are associated with higher levels of or more severe depression.

Change in Connor Davidson Resilience Scale (CD-RISC 10) score

Time frame: Baseline, 3 months

The Connor-Davidson Resilience scale (CD-RISC) measures resilience. Participants respond to 10 questions scored on a 5-point Likert scale of 0 (Not true at all) to 4 (True nearly all the time). A total score is calculated by summing the item responses and ranges from 0 to 40; with higher scores reflecting greater resilience.

Change in Difficulties in Emotion Regulation Scale (DERS-SF) score

Time frame: Baseline, 3 months

The Difficulties in Emotion Regulation Scale Short Form (DERS-SF) measures difficulties in emotion regulation in adults and adolescents. It consists of six subscales: Nonacceptance, Goals, Impulse, Awareness, Strategies, and Clarity, each with three items. Participants respond to 18 questions scored on a 5-point Likert scale of 1 (Almost never) to 5 (Almost always). A total score is calculating by summing the item responses and ranges from 18 to 90; higher scores indicate greater difficulty with emotion regulation skills.

Change in PROMIS Pediatric Pain Behavior (SF-8a) score

Time frame: Baseline, 3 months

The PROMIS Pediatric Pain Behavior (SF-8a) short form measures behaviors that typically indicate to others that an individual is experiencing pain. Participants respond to 8 questions scored on a 6-point Likert scale of 1 (Had no pain) to 6 (Almost always). A total score is calculated by summing the item responses and ranges from 8 to 48, with higher scores indicating a more pain related behavior.

Change in PROMIS Pediatric Pain Quality - Affective (SF-8a) score

Time frame: Baseline, 3 months

The PROMIS Pediatric Pain Quality- Affective (SF-8a) short form assesses the emotional distress that accompanies pain. Participants respond to 8 yes or no questions (0 = no, 1 = yes). A total score is calculated by summing the item responses and ranges from 0 to 8, with higher scores indicating a greater impact of pain on emotional distress.

Change in PROMIS Pediatric Pain Quality - Sensory (SF-8a) score

Time frame: Baseline, 3 months

The PROMIS Pediatric Pain Quality - Sensory (SF-8a) short form assesses the sensory experiences of pain. Participants respond to 8 questions scored on a 5-point Likert scale of 1 (Not at all) to 5 (Very much). A total score is calculated by summing the item responses and ranges from 8 to 40, with higher scores indicating participants experiencing increased sensory responses to pain.

Change in PROMIS Pediatric Physical Stress Experiences (SF-8a) score

Time frame: Baseline, 3 months

The PROMIS Pediatric Physical Stress Experiences (SF-8a) short form assess the physically experienced sensations associated with pain. Participants respond to 8 questions scored on a 5-point Likert scale of 1 (Never) to 5 (Always). A total score is calculated by summing the item responses and ranges from 8 to 40, with higher scores indicating a greater impact of pain on physical stress experienced.

Change in PROMIS Pediatric Psychological Stress Experience (SF) score

Time frame: Baseline, 3 months

The PROMIS Pediatric Psychological Stress Experience (SF) short form assesses the thoughts and feelings associated with pain. It measures facets of stress, including feeling overwhelmed, lack of perceived control, and cognitive-perceptual disruption, using a 7-day recall period. Participants respond to 8 questions scored on a 5-point Likert scale of 1 (Never) to 5 (Always). A total score is calculated by summing the item responses and ranges from 8 to 40, with higher scores indicating a greater impact of pain on psychological stress.

Change in PROMIS Pediatric Physical Activity (SF) score

Time frame: Baseline, 3 months

The PROMIS Pediatric Physical Activity (SF) measure self-reported capability of physical activities. Participants respond to 8 questions scored on a 5-point Likert scale of 0 (No days) to 5 (6-7 days). A total score is calculated by summing item responses and ranges from 0 to 40, with higher scores indicating a greater deal of physical activity.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.