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A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk Aim 3

ConditionOverdose
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13+
SponsorBoston Medical Center

About this trial

Between 2015 and 2019, overdose deaths translated to 1.25 million years of life lost among adolescents and young adults (youth) aged 12 to 24 years, and the percent change in fatal overdose rates among adolescents ages 14 to 18 was higher than adults between 2019 and 2020.3-5 Primary care providers are uniquely positioned to provide evidence-based information to youth to both improve awareness of overdose risk (individual benefit) and simultaneously ensure that youth are prepared to recognize and respond to an overdose (public health benefit). However, currently there is no evidence-based intervention for pediatric primary care to reduce youth overdose risk and ensure youth can recognize and respond to an overdose.

To address the gap in evidence-based overdose prevention interventions for youth, the investigators propose a randomized controlled trial (RCT) to evaluate the efficacy of a brief universal overdose prevention intervention in pediatric primary care. 24 providers and 624 youth patient participants randomized (at the provider level) to receive either the brief overdose prevention intervention or usual care will be enrolled.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Physicians and advance practice providers (nurse practitioners and physician assistants) within Pediatric Primary Care and Family Medicine at Boston Medical Center, NeighborHealth, and South Boston Community Health Center

≥ 1 clinic session per week

Ages 13 - 26

Scheduled for a CPE or follow-up clinical appointment with a provider who is participating in the trial

Disqualifiers

Participated as an intervention provider in the R61 pilot RCT (H-45731)

Participated in the Community Advisory Board that assisted in the development of the intervention (H-45388)

Caregivers of youth ages 13-17 unable to provide informed consent or are not English speaking

Cognitive limitation or intellectual disability that in the opinion of their provider would not be able to complete the requirements of the research

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brief youth overdose prevention education

    Behavioral

    Providers in the intervention group will inform youth participants about: the risk factors for overdose, how to stay safe and prevent overdose, how to recognize an overdose, and how to respond to an overdose. Providers in the intervention group will also inform youth participants how to use naloxone and facilitate access if youth would like to have it.

  • Usual Standard of Care

    Other intervention

    Youth participants will be provided usual care by providers in the control group. As part of usual care, providers may facilitate access to naloxone for youth control participants if they would like to have it.

Treatment groups

648 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Provider Fidelity to the Intervention

Providers in the intervention arm will complete a checklist after all CPEs and follow-up clinical appointments with youth ages 13 to 26 years. The checklist will assess provider consistency in delivery of the intervention including adherence to intervention topics and the provision of naloxone.

Time frame
12 months
2

Youth Fidelity to the Intervention

Youth in the intervention arm will complete a checklist after their CPEs and follow-up clinical appointments. The checklist will assess consistency in intervention delivery including adherence to intervention topics and whether naloxone was offered to the youth.

Time frame
12 months
3

Youth knowledge of risk associated with exposure to fentanyl and other emerging drugs

Assessed using a 4-point Likert-scale question measuring perceived risk of harm from taking prescription medication that was not prescribed or taking medication other than prescribed.

Time frame
Baseline, 3 months, 6 months, 9 months, and 12 months.

Secondary outcomes

1

Youth knowledge of strategies to reduce overdose risk

Assessed using 4-point Likert-scale questions measuring perceived risk associated with using more than one substance at a time and using substances while alone.

Time frame
Baseline, 3 months, 6 months, 9 months, and 12 months.
2

Youth's ability to recognize and respond to an overdose

Assessed using investigator-developed knowledge assessment questions evaluating recognition of overdose signs, appropriate overdose response, and knowledge of naloxone.

Time frame
Baseline, 3 months, 6 months, 9 months, and 12 months.

Other outcomes

Sponsors and contacts

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Boston Medical Center

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: