Apply to Trial

Compensation: Varies

Number of Visits: 3

Duration: 2 years

500 Participants Needed

Park Prescriptions for Child Health and Mental Wellness
(ParkRx Trial)

Overseen ByDeborah A Cohen, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Previous park prescription

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is a randomized controlled trial to evaluate ParkRx, a clinic-based counseling intervention in which health care providers prescribe park visits at a specific frequency, duration, and includes instructions for physical activity in the parks. We will assess whether prescribing visits to specific parks changes physical activity levels and improves health and mental health outcomes among low-income pediatric patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on adding park visits to your routine rather than changing your medication.

Is it safe for children to participate in park prescription programs for health and mental wellness?

The research articles provided do not contain specific safety data about park prescription programs for children. They focus on adverse drug reactions in children, which are not directly related to park prescriptions.¹ ² ³ ⁴ ⁵

How is the Park Rx treatment different from other treatments for child mental health?

Park Rx is unique because it involves prescribing time in nature as a treatment, which is different from traditional methods like medication or therapy. This approach focuses on the mental and physical benefits of spending time outdoors, which can improve mood and reduce stress without the side effects associated with drugs.⁶ ⁷ ⁸ ⁹ ¹⁰

What data supports the effectiveness of the treatment Park Rx for child health and mental wellness?

The research highlights the importance of community-based interventions and the role of primary care in treating children's mental health issues, suggesting that treatments like Park Rx, which involve outdoor activities, could be beneficial. Additionally, the focus on improving access to mental health care and integrating physical and mental health supports the potential effectiveness of Park Rx in promoting overall wellness.⁷ ¹¹ ¹² ¹³ ¹⁴

Who Is on the Research Team?

Deborah A Cohen, MD, MPH

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for low-income children aged 6-16 in the Washington DC area, who have chronic health conditions like ADHD, overweight/obesity, type 2 diabetes, or high cholesterol. They should need regular healthcare visits and plan to stay local for the next two years. Kids who've already had a park prescription can't join.

Inclusion Criteria

You have Attention Deficit Hyperactivity Disorder (ADHD).

You are significantly above a healthy weight.

I have type 2 diabetes.

See 5 more

Exclusion Criteria

- Individuals who have previously been given a park prescription

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive park prescriptions as part of their treatment plan to increase physical activity and improve health outcomes

2 years

Baseline, 3 months, 6 months, 12 months, and 2 years

Follow-up

Participants are monitored for changes in physical activity, BMI, lipids, and cognition

2 years

What Are the Treatments Tested in This Trial?

Interventions

Park Rx

Trial Overview The study tests Park Rx—a program where doctors prescribe park visits with specific instructions for physical activity—to see if it boosts kids' physical activity and improves their overall health and mental wellness.

How Is the Trial Designed?

2Treatment groups

Experimental Treatment

Active Control

Group I: Park RxExperimental Treatment1 Intervention

Participants will be given a park prescription as part of their treatment plan

Group II: No Park RxActive Control1 Intervention

Usual care only

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Unity Health

Collaborator

Trials

Recruited

22,900+

Published Research Related to This Trial

A total of 240 adverse drug reaction (ADR) reports were analyzed from children in Europe, revealing that the majority of reports came from infants under 1 year and teenage girls, highlighting a significant concern for drug safety in these age groups.

Serious ADRs were predominantly related to nervous system disorders, and vaccines and anti-infectives accounted for a significant portion of the reports, indicating the need for careful monitoring of these medications in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions in children reported by European consumers from 2007 to 2011.Aagaard, L., Hansen, EH.[2021]

In a study of 1036 pediatric inpatients, 63.5% received psychotropic medications, with 8.1% experiencing serious adverse drug reactions (sADRs), highlighting the risks associated with off-label drug use in children.

The use of a web-based pediatric drug information system (PDIS) could have potentially prevented 37 out of 54 documented sADRs, suggesting that PDIS is an effective tool for improving medication safety and reducing hospital stay durations and costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of a web-based pediatric drug information system to prevent serious adverse drug reactions in child and adolescent psychiatry.Fekete, S., Kulpok, C., Taurines, R., et al.[2023]