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NCT05380440 · ClinicalTrials.gov registry record · NA
Preventing Parental Opioid and/or Methamphetamine Addiction Within DHS-Involved Families: PRE-FAIR
A NA study of Opioid-Related Disorders and Child Neglect, sponsored by Chestnut Health Systems.
- Completed
- Registry status
- NA
- Development phase
- 241
- Enrollment target
- 1
- Study location
NCT05380440: Completed NA study of Opioid-Related Disorders and Child Neglect, sponsored by Chestnut Health Systems.
NCT05380440 is a NA study of Opioid-Related Disorders and Child Neglect that has completed, run by Chestnut Health Systems. The registered enrollment target is 241 participants, below the 342-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (30% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05380440, a NA study of Opioid-Related Disorders and Child Neglect, has completed, sponsored by Chestnut Health Systems.
- COMPLETED
- Registry status
- NA
- Development phase
- 241 participants
- Enrollment target
- 1
- Study location
Study Summary
Young parents aged 16 to 30, involved in the DHS system for child welfare or self-sufficiency needs are at risk for opioid use disorder and/or methamphetamine use disorder (OUD; MUD). Those identified as engaging in opioid or methamphetamine misuse are at high risk for escalation. Children of parents with OUD and MUD are at-risk for entering into foster care. Oregon is one state particularly affected by this challenge. The proposed research offers one potential solution by adapting and evaluating a recently developed treatment for parental OUD and MUD, for prevention. This study seeks to collaborate with Oregon Department of Humans Services (DHS) leadership to deliver a new outpatient prevention program to high-risk, young, parents. The Prevention Adaptation of Families Actively Improving Relationships (PRE-FAIR) program will include community-based mental health, parent management, and ancillary needs treatment, and ongoing monitoring and prevention services for opioid and methamphetamine use. This study will randomize 240 parents, aged 16 to 30, to receive PRE-FAIR or standard case management and referral, in two counties in Oregon. Outcomes will include an evaluation of the effectiveness of PRE-FAIR in addressing risk factors associated with substance use disorders in DHS-involved populations, OUD and MUD outcomes, and implementation outcomes including implementation process and milestones, and program delivery outcomes. Intervention and Implementation costs will be assessed, and the benefit of PRE-FAIR will be evaluated in relation to standard services, but also in relation to capacity and population needs. Study hypotheses are: (1) Parents randomized to PRE-FAIR will be less likely to escalate opioid and/or methamphetamine use, and to receive a diagnosis of OUD and/or MUD; (2) Parents randomized to PRE-FAIR will experience significant reductions in mental health, parent skills, and ancillary needs compared to those receiving standard services; (3) Counties will
Primary Outcome
Any opioid or methamphetamine use in the past 30 days measured by the Addiction Severity Index
Conditions Studied
Interventions
- BEHAVIORAL Prevention Adaptation of Families Actively Improving Relationships (PRE-FAIR)
- BEHAVIORAL Standard Case Management and Referral
Study Locations (1)
Oregon
- Chestnut Health Systems - Eugene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2021-06-09 |
| Est. Completion | 2025-06-02 |
| Phase | NA |
What the finished NCT05380440 record still lists
NCT05380440 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, below the 342-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (30% lower).
The record links to 4 conditions, with Opioid-Related Disorders appearing as the primary indexed condition, and to 2 interventions - of which Prevention Adaptation of Families Actively Improving Relationships (PRE-FAIR) is the first listed.
NCT05380440 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT05380440 about?
NCT05380440 is a clinical study titled "Preventing Parental Opioid and/or Methamphetamine Addiction Within DHS-Involved Families: PRE-FAIR". Young parents aged 16 to 30, involved in the DHS system for child welfare or self-sufficiency needs are at risk for opioid use disorder and/or methamphetamine use disorder (OUD; MUD). Those identified as engaging in opioid or methamphetamine misuse are at high risk for escalation. Children of parent...
What is the current status of trial NCT05380440?
This trial is currently completed. It is a NA study. The enrollment target is 241 participants. The study started on 2021-06-09. Estimated completion is 2025-06-02.
What conditions does trial NCT05380440 study?
This clinical trial studies the following conditions: Opioid-Related Disorders, Child Neglect, Mental Health Impairment, Stimulant-Related Disorder.
What interventions are being tested in trial NCT05380440?
The interventions under investigation include: Prevention Adaptation of Families Actively Improving Relationships (PRE-FAIR) (BEHAVIORAL), Standard Case Management and Referral (BEHAVIORAL).
Who is sponsoring clinical trial NCT05380440?
This trial is sponsored by Chestnut Health Systems, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05380440 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05380440's enrollment target sits among peer trials
241 16th of 47 higher than 32 of 47 other Opioid-Related Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid-Related Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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