BridgeMD
Prevention study for Substance-Related Disorders
Official title Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program
ClinicalTrials.gov ID: NCT06236100
What this study is testing
- What it's testing
- Primary Objective: Conduct a rigorous evaluation of a prevention-based intervention designed to mitigate the harms of adverse childhood experiences (ACEs) exposure and prevent future ACEs, substance use, and overdose within 36 communities experiencing a disproportionate burden of substance use and ACEs. The study has three aims: (1) use a cluster randomized controlled trial to test effectiveness of the Strengthening Families Program (SFP) + Family Advocate (FA) intervention on substance use, overdose, and ACEs in 18 communities compared with SFP-only in 18 communities; (2) conduct a robust process evaluation informed by the Consolidated Framework for Implementation Research (CFIR) to explore implementation barriers and facilitators; and (3) conduct a cost evaluation to accurately estimate the costs required to implement SFP and SFP+FA and assess the cost-effectiveness of SFP+FA relative to SFP alone.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 and older. Healthy volunteers may be eligible.
You may be able to join if
- To be eligible to participate in this study, a family must meet all of the following criteria:
- Either reside in, or attend SFP meetings, within one of the 36 New Jersey communities with disproportionate levels of ACEs and substance use disorder...
- Meet family eligibility requirements:
- One or more adult caregivers
- One or more adolescents, ages 7 to 17
You likely can't join if
- A family who meets any of the following criteria will be excluded from participation in this study:
- Caregiver has previously completed SFP with one or more children, ages 7 to 17
- Intellectual disabilities (i.e., cognitive impairments that would prohibit the completion of the SFP curriculum or data collection instruments)
- Language difficulties (caregivers and children must read and understand spoken English)
See the full eligibility criteria
- To be eligible to participate in this study, a family must meet all of the following criteria:
- Either reside in, or attend SFP meetings, within one of the 36 New Jersey communities with disproportionate levels of ACEs and substance use disorder (SUD) issues that are assigned to either the treatment or control...
- Meet family eligibility requirements:
- One or more adult caregivers
- One or more adolescents, ages 7 to 17
- Caregiver provision of signed and dated informed consent form
- For children, informed assent and parental permission via the informed consent to participate in the study
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Willingness to adhere to the regimens of the SFP and FA interventions
- Access to necessary resources for participating in a technology-based intervention (i.e., computer, smart phone, internet access)
- A family who meets any of the following criteria will be excluded from participation in this study:
- Caregiver has previously completed SFP with one or more children, ages 7 to 17
- Intellectual disabilities (i.e., cognitive impairments that would prohibit the completion of the SFP curriculum or data collection instruments)
- Language difficulties (caregivers and children must read and understand spoken English)
The study team makes the final eligibility decision.
Where it's taking place
- Tinton Falls, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tinton Falls, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.