Opioid-Related DisordersPRE-FAIRNCT05380440
Preventing Parental Opioid and/or Methamphetamine Addiction Within DHS-Involved Families: PRE-FAIR
A study testing Prevention Adaptation of Families Actively Improving Relationships (PRE-FAIR) and Standard Case Management and Referral in people with Opioid-Related Disorders and Stimulant-Related Disorder, run by Chestnut Health Systems at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders, Stimulant-Related Disorder, Child Neglect
- What is being tested?
- Prevention Adaptation of Families Actively Improving Relationships (PRE-FAIR) and Standard Case Management and Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Risk for opioid or methamphetamine misuse or escalation of use
- Parent of a child 0-18.
- Involvement or risk for involvement with self-sufficiency or child welfare systems.
- Aged 16 to 30 at date of intake assessment.
- Enrolled in Oregon Health Plan
- Child in home or reunification plan in place.
- Lives in a participating Oregon county.
Who cannot join
- Used methamphetamines or opioids 4 or more times in past year
- Active diagnosis of a methamphetamine or opioid use disorder
Trial locations and contacts
1 site in 1 country.
About this study
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 follow the implementation plan developed in collaboration between study team members and state leadership, and that doing so will yield successful implementation of PRE-FAIR; and (4) Implementation and intervention costs for PRE-FAIR will demonstrate a benefit for offering PRE-FAIR compared to standard services, particularly in rural communities where capacity influences service delivery decisions.
Read the detailed description
The Families Actively Improving Relationships (FAIR) program is a recently developed, rigorously evaluated, intensive outpatient treatment program for parents involved in the child welfare system for parental opioid and/or amphetamine type substance use disorder-methamphetamine (OUD; MUD). Outcomes from the FAIR effectiveness trial suggest the potential for FAIR to be adapted as a prevention program for parents involved with child welfare and self-sufficiency systems, and to be implemented in counties with low service availability and access. This exploratory-developmental phased project dedicates a year of activities toward collaborating with Oregon state Department of Human Services (DHS) partners and leadership to develop a plan for adaptation, recruitment, and implementation of FAIR for prevention (PRE-FAIR). The investigative team-with expertise in intervention development and clinical effectiveness trials, implementation science, decision science, health economics, and including DHS leadership-will work in collaboration with the Coordinating Center to develop strategies to identify, reach, and engage parents involved in the DHS system, aged 16 to 30, who are at-risk for escalation of misuse or development of OUD and/or MUD; and develop and adapt FAIR to prevent initiation of opioid and/or methamphetamine misuse and escalation to disorder. Following the completion of a set of concrete milestones during the first year, the project will conduct a Hybrid I randomized clinical trial, to evaluate the PRE-FAIR program and its implementation. Across two counties, parents referred by DHS for opioid or methamphetamine use or misuse with risk for escalation (n = 240), will be recruited and followed longitudinally for 24 months. Parents will be randomized to receive PRE-FAIR or standard case management and referral (STAND). Overarching goals of this study phase are to test the effectiveness of the adaptations designed in the previous phase and to build upon state collaborations-specifically, to: Evaluate the effectiveness of PRE-FAIR in preventing DHS-involved parents, aged 16 to 30, from initiating misuse or escalating opioid and/or methamphetamine use; Examine and assess the implementation of PRE-FAIR in the county-driven DHS system to inform sustainability plans; and Assess the implementation and intervention costs associated with the adoption of PRE-FAIR. Outcomes from this project will inform further refinement of protocols and the potential for broader scale-up of PRE-FAIR.
- Conditions
- Opioid-Related Disorders, Stimulant-Related Disorder, Child Neglect, Mental Health Impairment
- Being tested
- Prevention Adaptation of Families Actively Improving Relationships (PRE-FAIR), Standard Case Management and Referral
- Keywords
- Substance-Related Disorders, Preventive Health Services, Opioid-Related Disorders, Amphetamine-Related Disorders, Child Abuse
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders, Amphetamine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention Adaptation of Families Actively Improving Relationships (PRE-FAIR)Behavioural
FAIR is a behavioral intervention to treat parental substance use and child neglect for families involved in the child welfare system. This project will adapt the existing FAIR intervention for prevention (PRE-FAIR). FAIR involves four major treatment components, supported by ongoing purposeful engagement : (1) Substance use treatment including contingency management and positive reinforcement, frequent urinalysis, relationship building, day planning, healthy environments and peer choices, and refusal skills; (2) Mental health treatment including cognitive behavioral therapy, developing healthy coping skills, emotion regulation skills, exposure therapy, and referral for medication management; (3) Parent management training including parenting skills, nurturing and attachment, reinforcement, emotion regulation, supervision, structure, non-harsh discipline, and nutrition; and (4) Resource building and provision of ancillary supports including assistance with housing and employment.
Standard Case Management and ReferralBehavioural
Parents will be referred for a substance use and mental health assessment with possible resulting treatment. Child Welfare treatment plans typically include a series of recommendations, including parenting classes, securing safe housing, psychosocial treatment (e.g., domestic violence), accessing self-sufficiency services (e.g., food stamps, WIC), securing employment or education, and meeting court dates and requirements.
| Study group | Role | What they receive |
|---|---|---|
| PRE-FAIR | Experimental | Participants in this arm will receive the PRE-FAIR intervention. Receives: Behavioral: Prevention Adaptation of Families Actively Improving Relationships (PRE-FAIR) |
| Control | Active comparator | Participants in this arm will receive services standard case management and services . Receives: Behavioral: Standard Case Management and Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in opioid or methamphetamine use measured from Baseline to 24 months post-baseline
Any opioid or methamphetamine use in the past 30 days measured by the Addiction Severity Index
Measured: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Completion of Key Intervention Implementation Activities Over the Course of the Study
Measure of implementation progress as measured by the Stages of Implementation Completion (SIC).
Measured: Duration of the study, up to 4 years
Costs Associated with Key Intervention Implementation Activities Over the Course of the Study
Implementation costs associated with adoption of PRE-FAIR as measured by the Cost of Implementing New Strategies (COINS).
Measured: Duration of the study, up to 4 years
Mean changes in parent drug cravings and stress as measured by the Parent Daily Report
Parental stress and drug cravings as measured by the Parent Daily Report (PDR). Measured monthly from Baseline to 18-months post-Baseline and at 24-months post-Baseline.
Measured: Baseline, monthly for 18-months post-Baseline, 24-months post-Baseline
Mean changes in behavioral health services utilization
Behavioral health services utilization (mental health, substance use) including visits assessed in the Service Utilization Survey and PRE-FAIR visits assessed in the coach portal software. Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.
Measured: up to 24- months
Secondary outcomes (10)
Mean Changes in Drug Use Frequency and Severity from Baseline to 24-months Post-Baseline
Drug use frequency and severity measured through the Addiction Severity Index's (ASI) Drug Use subscale. Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.
Measured: Baseline to 24-months Post-Baseline
Changes in probability of opioid or methamphetamine use drug use as measured by Urinalysis testing
Urinalysis based multi-drug panel using the ICUP Drug Screening device. Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.
Measured: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Mean Changes From Baseline in Parenting Behaviors as Assessed by the BCAP at 24-months Post-Baseline
Parenting behaviors as measured by the Brief Child Abuse Potential Inventory (BCAP). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.
Measured: Baseline to 24-months Post-Baseline
Mean changes in anxiety symptoms reported as measured by the General Anxiety Disorder-7 (GAD-7)
Anxiety symptoms as measured by the General Anxiety Disorder-7 (GAD-7). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.
Measured: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Mean changes in depression severity as measured by the Patient Health Questionnaire-9 (PHQ-9)
Depression severity as measured by the Patient Health Questionnaire-9 (PHQ-9). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.
Measured: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Mean changes in post-traumatic stress and psychological effects of trauma as measured by the Trauma Symptom Inventory-2 (TSI-2)
Measure of PTSD symptoms and psychological effects of trauma as measured by the Trauma Symptoms Inventory-2 (TSI-2). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.
Measured: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Mean Changes in Mental Health Symptoms from Baseline to 24-months Post-Baseline
Mental health symptoms as measured by the Brief Symptom Inventory (BSI). Sum of responses to 53 Likert-type items, range 0-24. Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.
Measured: Baseline to 24-months Post-Baseline
Mean changes in parenting stress as measured by Parenting Stress Inventory
Parenting stress as measured by the Parent Stress Inventory (PSI). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.
Measured: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Descriptive Measures of FAIR Program Delivery
Descriptives of FAIR program delivery including: fidelity, attendance, caseload size, case characteristics, and session characteristics will be collected.
Measured: Duration of the study, up to 4 years
Mean Levels of Client Satisfaction with Services at the End of Treatment
Participants' self-reported perceptions of services as measured by the Client Satisfaction with Services Questionnaire (CSQ).
Measured: End of treatment, average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start9 Jun 2021
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chestnut Health Systems
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Lisa Saldana, Chestnut Health Systems
- Investigators
- Lisa Saldana, PhD, Principal investigator, Chestnut Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380440
- Sponsor's protocol ID
- 1174-0623
- Other IDs
- 7UH3DA050193
- Acronym
- PRE-FAIR
- Status last verified
- Jan 2026
- First submitted
- 12 Jul 2021
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As part of the HEAL Initiative, this study will follow the data sharing protocol set up by the Collaborating Center. Plan development currently in process.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Parental Opioid and/or Methamphetamine Addiction Within DHS-Involved Families: PRE-FAIR
- ClinicalTrials.gov ID
- NCT05380440
- Acronym / sponsor ID
- PRE-FAIR / 1174-0623
- Conditions
- Opioid-Related Disorders, Stimulant-Related Disorder, Child Neglect, Mental Health Impairment
- Keywords
- Substance-Related Disorders, Preventive Health Services, Opioid-Related Disorders, Amphetamine-Related Disorders, Child Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Chestnut Health SystemsUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 follow the implementation plan developed in collaboration between study team members and state leadership, and that doing so will yield successful implementation of PRE-FAIR; and (4) Implementation and intervention costs for PRE-FAIR will demonstrate a benefit for offering PRE-FAIR compared to standard services, particularly in rural communities where capacity influences service delivery decisions.
Detailed description
The Families Actively Improving Relationships (FAIR) program is a recently developed, rigorously evaluated, intensive outpatient treatment program for parents involved in the child welfare system for parental opioid and/or amphetamine type substance use disorder-methamphetamine (OUD; MUD). Outcomes from the FAIR effectiveness trial suggest the potential for FAIR to be adapted as a prevention program for parents involved with child welfare and self-sufficiency systems, and to be implemented in counties with low service availability and access. This exploratory-developmental phased project dedicates a year of activities toward collaborating with Oregon state Department of Human Services (DHS) partners and leadership to develop a plan for adaptation, recruitment, and implementation of FAIR for prevention (PRE-FAIR). The investigative team-with expertise in intervention development and clinical effectiveness trials, implementation science, decision science, health economics, and including DHS leadership-will work in collaboration with the Coordinating Center to develop strategies to identify, reach, and engage parents involved in the DHS system, aged 16 to 30, who are at-risk for escalation of misuse or development of OUD and/or MUD; and develop and adapt FAIR to prevent initiation of opioid and/or methamphetamine misuse and escalation to disorder. Following the completion of a set of concrete milestones during the first year, the project will conduct a Hybrid I randomized clinical trial, to evaluate the PRE-FAIR program and its implementation. Across two counties, parents referred by DHS for opioid or methamphetamine use or misuse with risk for escalation (n = 240), will be recruited and followed longitudinally for 24 months. Parents will be randomized to receive PRE-FAIR or standard case management and referral (STAND). Overarching goals of this study phase are to test the effectiveness of the adaptations designed in the previous phase and to build upon state collaborations-specifically, to: Evaluate the effectiveness of PRE-FAIR in preventing DHS-involved parents, aged 16 to 30, from initiating misuse or escalating opioid and/or methamphetamine use; Examine and assess the implementation of PRE-FAIR in the county-driven DHS system to inform sustainability plans; and Assess the implementation and intervention costs associated with the adoption of PRE-FAIR. Outcomes from this project will inform further refinement of protocols and the potential for broader scale-up of PRE-FAIR.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRE-FAIR | Experimental | Behavioral: Prevention Adaptation of Families Actively Improving Relationships (PRE-FAIR)Participants in this arm will receive the PRE-FAIR intervention. |
| Control | Active comparator | Behavioral: Standard Case Management and ReferralParticipants in this arm will receive services standard case management and services . |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Risk for opioid or methamphetamine misuse or escalation of use
- Parent of a child 0-18.
- Involvement or risk for involvement with self-sufficiency or child welfare systems.
- Aged 16 to 30 at date of intake assessment.
- Enrolled in Oregon Health Plan
Key exclusion criteria (2 listed)
- Used methamphetamines or opioids 4 or more times in past year
- Active diagnosis of a methamphetamine or opioid use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevention Adaptation of Families Actively Improving Relationships (PRE-FAIR)FAIR is a behavioral intervention to treat parental substance use and child neglect for families involved in the child welfare system. This project will adapt the existing FAIR intervention for prevention (PRE-FAIR). FAIR involves four major treatment components, supported by ongoing purposeful engagement : (1) Substance use treatment including contingency management and positive reinforcement, frequent urinalysis, relationship building, day planning, healthy environments and peer choices, and refusal skills; (2) Mental health treatment including cognitive behavioral therapy, developing healthy coping skills, emotion regulation skills, exposure therapy, and referral for medication management; (3) Parent management training including parenting skills, nurturing and attachment, reinforcement, emotion regulation, supervision, structure, non-harsh discipline, and nutrition; and (4) Resource building and provision of ancillary supports including assistance with housing and employment. | Behavioural | PRE-FAIR |
| Standard Case Management and ReferralParents will be referred for a substance use and mental health assessment with possible resulting treatment. Child Welfare treatment plans typically include a series of recommendations, including parenting classes, securing safe housing, psychosocial treatment (e.g., domestic violence), accessing self-sufficiency services (e.g., food stamps, WIC), securing employment or education, and meeting court dates and requirements. | Behavioural | Control |
Primary outcome
Change in opioid or methamphetamine use measured from Baseline to 24 months post-baseline
Time frame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Any opioid or methamphetamine use in the past 30 days measured by the Addiction Severity Index
Completion of Key Intervention Implementation Activities Over the Course of the Study
Time frame: Duration of the study, up to 4 years
Measure of implementation progress as measured by the Stages of Implementation Completion (SIC).
Costs Associated with Key Intervention Implementation Activities Over the Course of the Study
Time frame: Duration of the study, up to 4 years
Implementation costs associated with adoption of PRE-FAIR as measured by the Cost of Implementing New Strategies (COINS).
Mean changes in parent drug cravings and stress as measured by the Parent Daily Report
Time frame: Baseline, monthly for 18-months post-Baseline, 24-months post-Baseline
Parental stress and drug cravings as measured by the Parent Daily Report (PDR). Measured monthly from Baseline to 18-months post-Baseline and at 24-months post-Baseline.
Mean changes in behavioral health services utilization
Time frame: up to 24- months
Behavioral health services utilization (mental health, substance use) including visits assessed in the Service Utilization Survey and PRE-FAIR visits assessed in the coach portal software. Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.
10 secondary outcomes
Mean Changes in Drug Use Frequency and Severity from Baseline to 24-months Post-Baseline
Time frame: Baseline to 24-months Post-Baseline
Changes in probability of opioid or methamphetamine use drug use as measured by Urinalysis testing
Time frame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Mean Changes From Baseline in Parenting Behaviors as Assessed by the BCAP at 24-months Post-Baseline
Time frame: Baseline to 24-months Post-Baseline
Mean changes in anxiety symptoms reported as measured by the General Anxiety Disorder-7 (GAD-7)
Time frame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Mean changes in depression severity as measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Mean changes in post-traumatic stress and psychological effects of trauma as measured by the Trauma Symptom Inventory-2 (TSI-2)
Time frame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Mean Changes in Mental Health Symptoms from Baseline to 24-months Post-Baseline
Time frame: Baseline to 24-months Post-Baseline
Mean changes in parenting stress as measured by Parenting Stress Inventory
Time frame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Descriptive Measures of FAIR Program Delivery
Time frame: Duration of the study, up to 4 years
Mean Levels of Client Satisfaction with Services at the End of Treatment
Time frame: End of treatment, average of 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. As part of the HEAL Initiative, this study will follow the data sharing protocol set up by the Collaborating Center. Plan development currently in process.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Saldana, PhD principal investigator
Chestnut Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention Adaptation of Families Actively Improving Relationships (PRE-FAIR) and Standard Case Management and Referral in people with Opioid-Related Disorders and Stimulant-Related Disorder, run by Chestnut Health Systems at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in opioid or methamphetamine use measured from Baseline to 24 months post-baseline (time frame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.