Just Care for Families Program for Substance Use Disorders

Overseen By Lisa Saldana, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Chestnut Health Systems

Disqualifiers: Non-Oregon resident, Uninsured, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 9 months

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Just Care for Families, designed to assist parents in rural Oregon dealing with opioid or methamphetamine use and mental health issues. The program aims to improve family life by addressing key social factors affecting health, such as community support and resource access. Participants receive assistance in substance use treatment, mental health support, and parenting skills. The trial seeks parents who have used opioids or methamphetamine in the past year, have children, experience mental health symptoms, and live in specific Oregon counties. Participants must be on the Oregon Health Plan and have a way to connect digitally or by phone for regular check-ins. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for families facing similar challenges.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Just Care for Families program is safe for parents involved in the child welfare system?

Research shows that programs like Just Care for Families can assist families dealing with substance use issues. These programs aim to support both parents and children, enhancing family dynamics and ensuring safety. Studies on similar programs have found improvements in family functioning and the well-being and safety of children.

Regarding safety, these programs are generally well-tolerated. They do not involve medication, eliminating concerns about drug side effects. Instead, they focus on therapy and community support, which are considered safe methods of assistance. Research has reported no negative effects specific to the Just Care for Families program, suggesting it is safe for participants.

This study does not follow a specific trial phase, indicating a focus on evaluating program effectiveness rather than testing safety, as in drug trials. Participants can expect a safe experience centered on therapy and support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Just Care for Families program for substance use disorders because it offers a unique family-centered approach. Unlike traditional treatments that often focus solely on the individual, this program actively involves parents, creating a supportive environment that can enhance recovery outcomes. By engaging the whole family, it aims to address the underlying issues contributing to substance use, potentially leading to more sustainable recovery and improved family dynamics.

What evidence suggests that the Just Care for Families program is effective for preventing substance use disorders?

Research has shown that involving family members in treatment helps individuals with substance use problems achieve better outcomes. When families participate, individuals tend to remain engaged and experience improved results. Programs that remove obstacles to accessing help also enhance participation and outcomes. Family-based treatment can reduce the risk of child neglect and improve family relationships. These findings suggest that the Just Care for Families program, which participants in this trial will receive, includes family involvement and meets basic needs, potentially supporting parents with substance use issues and improving family well-being. ^{5 6 7 8 9}

Who Is on the Research Team?

Lisa Saldana, PhD

Principal Investigator

Chestnut Health Systems

Are You a Good Fit for This Trial?

This trial is for parents in rural areas involved with the Oregon Department of Human Services who are at risk of worsening opioid or methamphetamine use and mental health issues. It aims to help by addressing factors like poverty, education, and access to care that can affect their health.

Inclusion Criteria

Parents must not have used or misused opioids in the last year, and/or any methamphetamine use in the last year

Current mental health symptoms

Resident of participating counties (Lane, Linn, Benton, Douglas, Lincoln)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Just Care for Families intervention, which includes substance use treatment, mental health treatment, parent management training, community building, systems navigation, and addressing basic needs

9 months

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of substance use, mental health, and social determinants of health

9 months

Periodic assessments at 9 and 18 months post-baseline

Long-term Follow-up

Data collection on long-term outcomes related to substance use and mental health, including administrative data from ODHS and Medicaid

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Just Care for Families

Trial Overview The 'Just Care for Families' program is being tested. It's a behavioral intervention designed to treat substance abuse and child neglect among these parents. The study will look into how well it works, its impact on social challenges, and the costs for clinics providing this service.

How Is the Trial Designed?

Group I: Just Care for Families Experimental Treatment 1 Intervention

Parents receiving Just Care for Families

Just Care for Families is already approved in United States for the following indications:

Approved in United States as Just Care for Families for:

• Substance use treatment
• Mental health treatment
• Parent management training
• Community building
• Systems Navigation
• Addressing basic needs

Who Is Running the Clinical Trial?

Chestnut Health Systems

Lead Sponsor

Trials

27

Recruited

24,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The North Carolina Plan of Safe Care (NC POSC) was implemented to support substance-affected infants and their families, but many healthcare providers were unaware of the program, highlighting a need for better communication and education among stakeholders.

From January 2018 to October 2019, 91% of notifications for substance-affected infants were screened for maltreatment, with a significant portion (70%) related to prenatal marijuana exposure, indicating a critical area for intervention and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the North Carolina Plan of Safe Care in Wake County, North Carolina. Austin, AE., Shanhan, ME., Rosemond, P., et al.[2022]

The continuing care substance abuse recovery program effectively supports substance-abusing parents in regaining their roles within their families while providing education and skills for effective parenting and relapse prevention.

The intervention addresses both individual and family dynamics, demonstrating positive outcomes in recovery and family functioning through case examples, highlighting its efficacy in helping substance-affected families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-home continuing care services for substance-affected families: the bridges program. Gruber, KJ., Fleetwood, TW., Herring, MW.[2019]

Family members of individuals with substance use disorders (SUDs) are significantly affected, facing increased health risks and high healthcare costs, yet they play a crucial role in the treatment and recovery process.

Evidence-based interventions that involve family members can lead to improved health outcomes for families, better treatment results for individuals with SUDs, and prevention of substance use in adolescents, highlighting the need for a family-centric approach in SUD care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To Improve Substance Use Disorder Prevention, Treatment and Recovery: Engage the Family. Ventura, AS., Bagley, SM.[2018]

Family involvement in addiction treatment can significantly improve outcomes, including treatment entry and completion, yet current services often focus on individuals rather than families.

This scoping review aims to identify the extent and nature of existing evidence on family interventions in addiction treatment, highlighting gaps to inform future research and best practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-focused practices in addictions: a scoping review protocol. Kourgiantakis, T., Ashcroft, R.[2018]

Women receiving integrated care for substance abuse during pregnancy reported feeling more comfortable with healthcare teams that maintained a consistent nonjudgmental attitude.

Effective communication among providers and between providers and patients, along with support groups, were key factors in enhancing the overall care experience for these women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participant perception of an integrated program for substance abuse in pregnancy. Lefebvre, L., Midmer, D., Boyd, JA., et al.[2018]

The brief family treatment (BFT) intervention for substance-abusing patients during inpatient detoxification showed a trend towards increased likelihood of entering aftercare programs and attending more days of aftercare compared to a treatment as usual (TAU) group, with a medium to large effect size.

Patients who participated in BFT and had in-person family meetings reported fewer days of substance use in the three months following detox, indicating that family involvement may enhance the effectiveness of aftercare support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief family treatment intervention to promote aftercare among male substance abusing patients in inpatient detoxification: A quasi-experimental pilot study. O'Farrell, TJ., Murphy, M., Alter, J., et al.[2019]

In a study of 2,789 veterans with substance use disorders, those who met the HEDIS engagement criterion showed significantly greater improvements in addiction severity compared to those who did not engage, particularly in alcohol and legal outcomes.

While the improvements were statistically significant, they were described as clinically modest, suggesting that while engagement in treatment is beneficial, the extent of improvement may vary among individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does meeting the HEDIS substance abuse treatment engagement criterion predict patient outcomes? Harris, AH., Humphreys, K., Bowe, T., et al.[2021]

A study involving 96 experts used the Classic e-Delphi method to identify and reach consensus on the needs of family caregivers of individuals with substance use disorder (SUD), highlighting ten key resource needs.

The findings emphasized the importance of increasing access to healthcare services, promoting self-care strategies for families, and advocating against stigma related to SUD, which are crucial for enhancing caregiver resilience and coping mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

e-Delphi Study: Expert Consensus on the Needs and Resources Available to Family Caregivers of Individuals with Substance Use Disorder. Tyo, MB., McCurry, MK.[2023]

The study identified five distinct models of integrated care for families affected by opioid use disorder (OUD), emphasizing the need for supportive and frequent visits with various providers, although billing constraints hinder full integration of services.

Key components for effective dyadic care include prioritizing care coordination, overcoming barriers to integrate medical and behavioral services, and ensuring child safety while maintaining parental trust, highlighting the complexities of addressing both parental and infant health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring for Families Impacted by Opioid Use: A Qualitative Analysis of Integrated Program Designs. Schiff, DM., Partridge, S., Gummadi, NH., et al.[2023]

A qualitative study involving interviews with 20 staff and providers at 3 harm reduction and medical care sites in New York identified 8 key themes for integrating harm reduction into patient care, emphasizing a collaborative and stigma-free environment.

The findings suggest that adopting harm reduction strategies, such as low-threshold care and robust referral networks, can help medical providers effectively engage patients with substance use disorders and improve their overall care experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Harm Reduction into Medical Care: Lessons from Three Models. Chang, JE., Lindenfeld, Z., Hagan, H.[2023]

The low-threshold group-based MOUD program at a federally qualified health center in Philadelphia effectively increased patient access and retention through its person-centered harm reduction approach and integration into primary care.

Challenges included varying staff acceptance of harm reduction principles and the need to manage clinic workflow, highlighting the importance of understanding both strengths and challenges for similar programs in other clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It's a place that gives me hope": A qualitative evaluation of a buprenorphine-naloxone group visit program in an urban federally qualified health center. Lai, S., Li, E., Silverio, A., et al.[2022]

The National Partnership for Maternal Safety has developed a Consensus Bundle on Obstetric Care specifically for pregnant and postpartum women with opioid use disorder, aiming to standardize care and improve maternal and neonatal health outcomes.

Implementation resources and quality improvement initiatives are being created to help healthcare providers adopt these evidence-based recommendations, ensuring consistent and safe care for women affected by substance use during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Partnership for Maternal Safety: Consensus Bundle on Obstetric Care for Women With Opioid Use Disorder. Krans, EE., Campopiano, M., Cleveland, LM., et al.[2021]

The <<Familias que Funcionan>> program, implemented in four secondary schools with 380 students in Asturias, effectively reduced adolescent drug use over a two-year follow-up period, showing significant decreases in drug use rates.

Consistent attendance in the program also positively impacted certain family risk factors associated with drug use, indicating that family involvement is crucial in prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Family-based drug use prevention: the "Familias que Funcionan" ["Families that Work"] program]. Errasti Pérez, JM., Al-Halabí Díaz, S., Secades Villa, R., et al.[2019]

Collaboration between agencies addressing substance abuse treatment and child welfare significantly improves child safety, parental recovery, and overall family well-being, based on data from over 15,000 families served by 53 federal grantees.

The study highlights effective strategies that can help reduce negative outcomes for families affected by substance use disorders, emphasizing the importance of integrated support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promising Results for Cross-Systems Collaborative Efforts to Meet the Needs of Families Impacted by Substance Use. Dennis, K., Rodi, MS., Robinson, G., et al.[2016]

A new Plan of Safe Care was developed to improve perinatal support for families affected by parental substance use, addressing barriers to accessing prenatal care and treatment services.

This plan promotes care coordination by engaging both patients and healthcare providers, facilitating better delivery planning and resource alignment for families with substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating Integrated Perinatal Care for Families Affected by Substance Use. Schmidt, CN., Patel, D., Alpers, BS., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3725219/

The Impact of Substance Use Disorders on Families and ... SUDs negatively affect emotional and behavioral patterns from the inception of the family, resulting in poor outcomes for the children and adults with SUDs.

2. library.samhsa.gov library.samhsa.gov/sites/default/files/advisory-low-barrier-models-of-care-pep23-02-00-005.pdf

Low Barrier Models of Care for Substance Use Disorders Research demonstrates the potential effectiveness of low barrier care in improving treatment engagement and outcomes for individuals with substance use ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11367307/

Family-centred interventions for people with substance use ... This review aims to synthesise the existing evidence on family-centred interventions for improving substance use and/or psychosocial outcomes in individuals ...

4. casey.org casey.org/media/SF_Substance-use-family-based-treatment-programs.pdf

How can family-based residential treatment programs help focused only on substance use disorders, and were just as effective as treatment focusing only on substance use disorders. • Lowered the risk of child ...

5. recoveryanswers.org recoveryanswers.org/research-post/involve-family-in-treatment-enhance-substance-use-disorder-outcomes/

Involving family members in substance use disorder ... This study summarizes findings from clinical trials that include significant other involvement and demonstrates its effectiveness when combined with individual ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12320045/

Caregiver substance use among families in the U.S. child ... Caregiver substance use is a significant risk factor for child maltreatment, considering that it can impair caregivers' ability to provide safe ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04637581

Wraparound for High-risk Families with Substance Use ... Data Collection. Outcomes will be measured on five domains: Family Functioning (primary), Child Well-Being, Child Safety, Child Permanency, Parent Recovery.

8. samhsa.gov samhsa.gov/data/data-we-collect/nsduh-national-survey-drug-use-and-health/national-releases/2022

2022 National Survey on Drug Use and Health (NSDUH) ... The 2022 NSDUH Detailed Tables present national estimates of substance use, mental health, and treatment in the United States.

9. casey.org casey.org/substance-use-disorders-keep-families-together/

How can families affected by substance use disorder safely ... This brief offers strategies for minimizing the time children are separated from parents as a result of substance use disorder.