Active Case Management for Domestic Violence

(SCOPE Trial)

Overseen By Rebecca Beebe, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Kevin Borrup

Disqualifiers: Behavioral health, DCF or police custody

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

225 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce violence exposure in children and families in Hartford by connecting them with community services. Participants will be divided into two groups: one will receive active case management, where a coordinator reaches out monthly to assist in connecting them to services, while the other will receive a list of resources to connect on their own. The trial seeks children aged 8 to 17 who live in Hartford and visit Connecticut Children's during recruitment hours. Families interested should be able to communicate in English or Spanish and should not have behavioral health as their primary concern. As an unphased trial, this study offers families the opportunity to access valuable community resources and support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that active case management is safe for children and families?

Studies on active case management for domestic violence have examined how these programs help families connect to community services. These studies suggest that this approach is generally well-received. While no serious side effects have been reported, the focus remains on improving access to support rather than introducing new medical treatments. Participants primarily work with case managers who guide them to available resources.

Because the program links families to existing services, the risks are low. Participants can expect supportive interactions aimed at meeting their needs and improving their situation. So far, reports of harmful outcomes from these types of programs have not emerged. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring a proactive approach to managing domestic violence cases. Unlike the usual treatment, which mainly offers a list of community resources, the intervention in this trial involves active case management. This means families receive consistent monthly contact from a case manager to help connect affected youth with necessary community services. This hands-on support and regular follow-up aim to better address the needs of families and ensure they are actively linked to the resources that can make a real difference in their lives.

What evidence suggests that active case management is effective for reducing violence exposure?

This trial will compare Active Case Management with Treatment as Usual. Studies have shown that actively helping families manage their situations can reduce violence. Programs that connect families with community services, such as Active Case Management in this trial, have been linked to positive outcomes. Research indicates that organized support helps families access necessary resources more easily. This support can lead to less violence and improved overall well-being for everyone involved. These programs prove more effective than simply providing families with a list of resources without direct assistance, which is the approach used in the Treatment as Usual arm of this trial. ^{1 2 4 6 7}

Who Is on the Research Team?

Kevin Borrup, DrPH

Principal Investigator

Connecticut Children's

Are You a Good Fit for This Trial?

This trial is for children and teens aged 8-17 from Hartford, accompanied by a consenting parent or guardian. They must be able to assent/consent in English or Spanish and visit CT Children's during recruitment hours. Those with behavioral health issues or in DCF/police custody cannot join.

Inclusion Criteria

I can understand and agree to the study's requirements.

I am between 8 and 17 years old.

Hartford resident based on zip code of primary residence or parent report

Exclusion Criteria

Patients whose primary complaint is for behavioral health

Patients in Connecticut Department of Children and Families (DCF) or police custody

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive active case management to connect affected youth to community services. Families are contacted monthly by the case manager for additional support.

12 months

Monthly contacts, quarterly assessments

Follow-up

Participants are monitored for changes in violence exposure, resilience, and satisfaction with case management services.

12 months

Quarterly assessments

What Are the Treatments Tested in This Trial?

Interventions

• Active Case Management
• Treatment as usual

Trial Overview

The SCOPE project tests if connecting families to a Care Coordinator can reduce violence exposure. It compares 'treatment as usual' with 'Active Case Management' where coordinators actively help families navigate services.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 2 Interventions

Enrolled subjects will provide the study team with email, mobile, work phone, physical contact address, and contact numbers for two or more close contacts. Families will be contacted monthly by the case manager assist with additional supports they might need. Quarterly, patients and families will be contacted and patients will be asked to complete VPET and other measures. The intervention group will receive active case management to connect affected youth to community services.

Group II: Treatment as Usual Active Control 1 Intervention

The comparison group will receive treatment as usual which consists of a list of community resources and a recommendation that youth not already connected with a community service provider be connected.

Treatment as usual is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Nicotine Replacement Therapy (NRT) for:

• Smoking cessation

Approved in United States as Bupropion (Zyban) for:

• Smoking cessation

Approved in Canada as Varenicline (Chantix) for:

• Smoking cessation

Who Is Running the Clinical Trial?

Kevin Borrup

Lead Sponsor

Trials

1

Recruited

230+

The Tow Foundation

Collaborator

Trials

1

Recruited

230+

Published Research Related to This Trial

In a pilot study involving 214 inpatients over three months, the recording of patient smoking status in medical notes significantly increased from 1.9% to 11.4%, indicating improved awareness and documentation of smoking habits.

The proportion of inpatients offered smoking cessation treatment rose from 11.0% to 26.8%, suggesting that targeted interventions can enhance access to smoking cessation resources in mental health settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted Intervention to Reduce Smoking among People with Severe Mental Illness: Implementation of a Smoking Cessation Intervention in an Inpatient Mental Health Setting. Lappin, JM., Thomas, D., Curtis, J., et al.[2021]

In a study of 3140 psychiatric inpatients, 35% reported daily tobacco smoking, but very few received effective tobacco cessation treatments upon discharge, highlighting a significant gap in care.

Barriers to initiating smoking cessation treatment included low prioritization of tobacco use, the belief that it should be managed by outpatient providers, and a lack of education among staff about available treatments, suggesting a need for improved training and intervention strategies in inpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary barriers to addressing tobacco cessation during an inpatient psychiatric hospitalization. Schnitzer, K., AhnAllen, CG., Beck, S., et al.[2021]

A study involving 1,938 participants with serious mental illness (SMI) showed that proactive outreach for tobacco cessation significantly increased engagement in counseling (22% vs. 3%) and use of nicotine replacement therapy (51% vs. 41%) compared to usual care.

Participants receiving proactive outreach were more likely to achieve abstinence from smoking (18% vs. 11%) after 12 months, highlighting the effectiveness of this approach in promoting tobacco cessation among smokers with SMI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Proactive Tobacco Cessation Treatment Outreach Among Smokers With Serious Mental Illness. Japuntich, SJ., Hammett, PJ., Rogers, ES., et al.[2021]

The implementation of a smoking cessation intervention in Queensland's adult acute psychiatry inpatient units led to a sustained high rate of smoking status documentation, exceeding 90% even three years after the intervention began.

While the percentage of discharges with a completed smoking cessation intervention stabilized during the maintenance phase, the overall effectiveness of the system change intervention in addressing smoking among inpatients remained significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can improvement in delivery of smoking cessation care be sustained in psychiatry inpatient settings through a system change intervention? An analysis of statewide administrative health data. Plever, S., Kisely, S., Bonevski, B., et al.[2023]

In a study of 60 adolescents and young adults with mental health issues, 11% to 17% achieved confirmed 7-day point prevalence abstinence from smoking at 3, 6, and 12 months, indicating that while some participants benefited from the intervention, overall success rates were modest.

The study found that girls had significantly higher rates of abstinence compared to boys, and lighter smokers were more likely to quit than heavier smokers, suggesting that gender and smoking intensity are important factors in tobacco cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gender differences in a randomized controlled trial treating tobacco use among adolescents and young adults with mental health concerns. Prochaska, JJ., Fromont, SC., Ramo, DE., et al.[2018]

A clinical practice change intervention significantly increased the provision of nicotine dependence treatment in inpatient psychiatric facilities, with improvements in five key outcome measures over a 19-month period involving 4175 patients.

The intervention included strategies like training, leadership support, and systematic audits, leading to notable increases in clinician assessments and treatment provisions, aligning with clinical guidelines for smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a clinical practice change intervention in increasing the provision of nicotine dependence treatment in inpatient psychiatric facilities: an implementation trial. Wye, PM., Stockings, EA., Bowman, JA., et al.[2022]

A statewide initiative in Queensland successfully increased the routine screening of smoking status among adult acute mental health inpatients from 88% to 97% over two years.

The implementation of a brief smoking cessation intervention for identified smokers also improved significantly, rising from 38% to 73%, highlighting the effectiveness of the clinical practice change in addressing smoking in mental health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Queensland smoking care in adult acute mental health inpatient units: Supporting practice change. Plever, S., McCarthy, I., Anzolin, M., et al.[2021]

In a study of 500 smokers under community corrections supervision, standard behavioral counseling did not significantly improve overall smoking cessation rates, with an end-of-treatment abstinence rate of only 9.4%.

However, the effectiveness of counseling varied by race: white smokers benefited from counseling, showing higher quit rates, while African American smokers who did not receive counseling had better cessation rates, suggesting that medication adherence plays a crucial role in achieving smoking cessation regardless of race.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Race and Medication Adherence Moderate Cessation Outcomes in Criminal Justice Smokers. Cropsey, KL., Clark, CB., Zhang, X., et al.[2022]

Stakeholders in community mental health centers (CMHCs) expressed a strong interest in integrating tobacco cessation treatments, highlighting the need for such services given the high prevalence of tobacco use among individuals with serious mental illness.

The study identified that both the 5 As model and proactive outreach strategies for tobacco cessation are viewed as feasible and acceptable, with participants requesting additional support and resources to effectively implement these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Chronic Care Model Treatments for Cigarette Dependence in Community Mental Health Clinics. Japuntich, SJ., Adkins-Hempel, M., Lundtvedt, C., et al.[2023]

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