Park Prescriptions for Child Health and Mental Wellness

(ParkRx Trial)

Overseen By Deborah A Cohen, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

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

Compensation: Varies

Number of Visits: 3

Duration: 2 years

500 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{2 11 12 13 14}

Research Team

Deborah A Cohen, MD, MPH

Principal Investigator

Kaiser Permanente

Eligibility Criteria

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.

Exclusion Criteria

- Individuals who have previously been given a park prescription

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Park Rx Experimental Treatment 1 Intervention

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

Group II: No Park Rx Active Control 1 Intervention

Usual care only

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Unity Health

Collaborator

Trials

5

Recruited

22,900+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Is more better than less? An analysis of children's mental health services. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Using Measurement-Based Care Data in Population Health Management. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Mental Health Trends in Military Pediatrics. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Paddington Complexity Scale and Health of the Nation Outcome Scales for Children and Adolescents. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Recognition and treatment of mental disorders in children: considerations for pediatric health systems. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse drug reactions in children reported by European consumers from 2007 to 2011. [2021]

7. Slovakia pubmed.ncbi.nlm.nih.gov

Methodological approaches to ADR detection in out-patient children. [2016]

8. Canada pubmed.ncbi.nlm.nih.gov

Paediatric adverse drug reaction reporting: understanding and future directions. [2013]

9. Austria 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. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Antibiotic-related adverse events in paediatrics: unique characteristics. [2019]

11. Canada pubmed.ncbi.nlm.nih.gov

Psychotropic drugs in children: a guide for the family physician. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Clinicians' Experience with a Graduate Medical Education Implemented Child Psychiatry Access Program. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

DC Mental Health Access in Pediatrics: Evaluating a Child Psychiatry Access Program in Washington, DC. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Trends and issues in child and adolescent mental health. [2019]