The Puerto Rico Asthma Integrated Response Program ("PR-AIR")

BEHAVIORAL

CASE in person version (High Intensity Package)

Controlling Asthma in Schools Effectively (CASE) is a multi-level school-based asthma management program delivered by a Community Health Worker (CHW) that includes 1) staff training involving education on asthma management in school, 2) child-based asthma management education with an emphasis on control of symptoms in the school setting provided in a group setting during the school day, 3) caregiver education after school involving supporting children's asthma control in the school setting, 4), and provision of an Asthma Action Plan (AAP) to the school for child enrollees.

BEHAVIORAL

CASE-V remote version (Low Intensity Package)

CASE-V, the low intensity version of CASE, includes similar child and caregiver-based asthma management education that is provided in a remote format with adaptation to integrate technological feature of Zoom. All CASE-V components (for staff, children, and parents) have been adapted to promote engagement (e.g., use of chat and polling function).

BEHAVIORAL

CASE and HARP in person (High Intensity package)

Children with "poorly controlled" asthma will receive both the CASE and HARP programs. HARP is a home-visiting program that includes individualized asthma management education and strategies and supplies for environmental remediation. All 3 visits can be conducted by a CHW. The first includes a "walk-through" to identify triggers. Asthma education and self-management strategies are provided using a structured protocol and low-literacy flip-book (English or Spanish). Referrals and advocacy are offered to address asthma management barriers (e.g., communication with landlord/housing re: code violation). The 2nd and 3rd visits include delivery of supplies (e.g., HEPA vacuum, pest gels, mattress covers), instruction for use, review of AAP, and follow-up on environmental control recommendations provided during the 1st visit.

BEHAVIORAL

CASE-V and HARP-V remote version (Low Intensity package)

HARP-V replicates the content delivered in HARP in a remote format. The first session includes a virtual "walk-through" in which the educator uses a structured script and checklist to guide the caregiver through the home and show specific components of the environment (e.g., carpeting, area under the kitchen sink, exhaust fan in bathroom) to identify asthma triggers. Asthma education and self-management strategies are provided using a structured protocol and slide overview based on the HARP flip-book. Supplies for environmental remediation are delivered prior to the 2nd visit. The 2nd and 3rd visit include instruction for use of supplies, review of AAP, and follow-up on recommendations and referrals.

Change in Child Asthma Control (Individual Level, ages 2-4 years)

Time frame: Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.

Effectiveness of the intervention on child-level asthma control is measured using the Test for Respiratory and Asthma Control in Kids (TRACK). The TRACK is a 5-item measure assessing asthma symptoms and control in young children by caregiver report. Items assessing frequency of various asthma-related events (e.g., breathing problems, quick-relief medication use, etc.) are rated on a Likert-type scale from Not at all (scored 20) to Extremely (scored 0). Scores \< 80 suggest child's asthma is not well controlled.

Change in Child Asthma Control (Individual Level, ages 5-11 years)

Time frame: Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.

Effectiveness of the intervention on child-level asthma control is measured using the Childhood Asthma Control Test (cACT). Children answer 4 questions on a 0-3 scale, and caregivers answer 3 questions on a 0-5 scale related to the frequency child's asthma symptoms in the previous 4 weeks. Lower scores indicate worse symptoms. Scores of 19 or less suggest asthma is not well controlled.

Change in Child Asthma Control (Individual Level; ages 12 and up)

Time frame: Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.

Effectiveness of the intervention on child-level asthma control is measured using the Asthma Control Test. Youth ages 12 and up complete 5-items related to their asthma on Likert-type scales ranging from 1-5, with lower scores indicating more severe symptoms. A cutoff score \<19 indicates suboptimal asthma control; scores \<=15 suggest poorly controlled asthma.

Health Care Utilization-ED visits (Community Level)

Time frame: 12 months pre- and post-intervention year

Health care utilization will be assessed by community-level rates of Emergency Department visits of children within the targeted geographic area. Obtaining utilization rates in this way will help the researchers to assess effectiveness of the intervention on the community level.

Health Care Utilization-Hospitalizations (Community Level)

Time frame: 12 months pre- and post-intervention year

Effectiveness of the intervention on the community level. Health care utilization will be assessed by community-level rates of hospitalizations in children within the targeted geographic area.

Health Care Utilization-Urgent Care Visits (Community Level)

Time frame: 12 months pre- and post-intervention year

Effectiveness of the intervention on the community level. Health care utilization will be assessed by community-level rates of urgent care visits in children within the targeted geographic area.

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.